Annotation. A new coronavirus infection is a disease that, in addition to the respiratory system, can affect the gastrointestinal tract due to the affinity of the virus to endothelial receptors with the manifestation of dyspeptic syndrome. The manifestation of gastrointestinal disorders can be associated not only with viral damage, but also with the action of antiviral and antibacterial drugs used to treat COVID-19.

The purpose of this study is to analyze the effectiveness of enterosorbents in the treatment of dyspeptic syndrome in patients with a new coronavirus infection. This retrospective analysis evaluates the possibility of using drugs with a high sorption capacity in reducing the viral load in the intestine, thereby reducing the clinical symptoms of gastrointestinal tract damage in COVID-19.

Keywords: coronavirus, SARS-CoV-2, COVID-19, symptoms of gastrointestinal tract damage, dyspepsia, diarrhea, Polisorb MP, colloidal silicon dioxide.

Today the world faces the rise of the incidence rate due to the new coronavirus infection COVID-19. Clinical and epidemiological specifics of this disease are continuously studied and new means of its diagnostic assessment, treatment and prevention are being developed. Aside from fever and respiratory disorders patients often make complaints of the dyspeptic nature of COVID-19 infection.

During the SARS-CoV coronavirus outbreak in 2003 every fourth patient complained of diarrhea [1]. It stemmed from coronavirus receptors being not only in the respiratory tract, but also on the mucous membranes of the gastrointestinal tract. Similar situations happen with SARS-CoV-2. Viral infection starts with its entry into target cells, the surface of which has receptors of angiotensin-converting enzyme II (ACE2).  Receptors, which the virus uses to enter the cell, are situated on enterocytes – cells of epithelium of the small intestine. Disruption of these receptors is the cause of diarrhea when being infected with a coronavirus.

A study by Chinese scientists from the Fifth Hospital at Sun Yatsen University has shown that 55% of coronavirus patients have the virus RNA in their stool samples, and can be detected there within 9-27 days from the moment the first symptoms appear [2].

Appearance of gastrointestinal disorders can be connected, apart from a viral disease, to the effect of antiviral and antimicrobial drugs used for the treatment of the COVID-19 coronavirus infection.

The use of drugs with high sorption activity and a significant absorbing area can reduce the viral load in the intestine and thus reduce the clinical manifestations of dyspepsia associated with the new coronavirus infection. One of these drugs is Polisorb MP, an inorganic non-selective multifunctional enterosorbent based on highly dispersed silica with a particle size of up to 0.09 mm and a chemical formula of SiO2, which has pronounced sorption and detoxification properties. In the intestinal lumen the drug binds and removes from the body endogenous and exogenous toxic substances of various nature, including pathogenic bacteria and bacterial toxins, antigens, food allergens, drugs and poisons, heavy metal salts, radionuclides and alcohol. Polisorb MP also sorbs some metabolic products of the body, including an excess of bilirubin, urea, cholesterol and lipid complexes, as well as metabolites responsible for the development of endogenic toxicosis.

Aim of the research: to determine the effectiveness of the enterosorbent in dyspeptic syndrome relief in patients with the new coronavirus infection – COVID-19.

METHODS AND MATERIALS

A retrospective analysis of 254 medical records of patients hospitalized at the Regional Budgetary Healthcare Institution City Clinical Hospital No. 1 in Ivanovo in April-September of 2020 was carried out. They were diagnosed with a new coronavirus infection on the basis of clinical and epidemiological data, confirmed virologically — by the detection of SARS-CoV-2 virus RNA on the mucous membranes of the nasopharynx via the PCR method. The condition of all patients included in the study was assessed as moderate or severe. Patients underwent laboratory and instrumental examination, treatment in accordance with the Interim Guidelines of the Ministry of Health of Russia «Prevention, diagnosis and treatment of the new coronavirus infection (COVID-19)» [3].

Symptoms of gastrointestinal dyspepsia were recorded in 82 patients (32.2%), that is, every third patient complained of nausea, vomiting, abdominal pain, and loose stools. Characteristics of the existing clinical symptoms of gastrointestinal tract lesions are presented in Table 1. These patients were divided into 2 groups:

Group 1 (treatment group) – 56 patients (68.3%) who were prescribed the Polisorb MP enterosorbent to counter the effects of dyspepsia;

Group 2 (control group) – 26 patients (31.7%) who were not administered enterosorbents.

Table 1

Characterization of clinical symptoms of gastrointestinal tract lesions in patients with novel coronavirus infection COVID-19

Symptoms	Symptom occurrence
	Group 1, n=56		Group 2, n=26		Total, n=82
	patients	%	patients	%	patients	%
Nausea: persistent sporadic	38 18	67.8 32.2	19 7	73.1 26.9	57 25	69.5 30.5
Vomiting: up to 3 times per day more than 3 times per day	22 10	39.2 17.8	8 3	30.7 11.5	30 13	36.5 15.8
Regurgitation: persistent sporadic	4 11	7.2 19.6	2 4	7.7 15.3	6 15	7.3 18.3
Heartburn: persistent sporadic	4 7	7.2 12.5	1 3	3.8 11.5	5 10	6.1 12.2
Bitter taste in the mouth: persistent sporadic	10 16	17.8 28.6	5 7	19.2 26.9	15 23	18.3 28.1
Pain: in the epigastrium and upper abdomen predominantly in the umbilical region mainly in the lower abdomen	26 10 3	46.4 17.8 5.3	12 4 1	46.7 15.3 3.8	38 14 4	46.3 17.1 4.9
Constipation	—	—	6	23.1	6	7.3
Diarrhea (more than 3 times per day): persistent sporadic	6 13	10.7 23.2	3 5	11.5 19.2	9 18	11.0 22.0
Dryness of the mucous membranes of the oropharynx	44	78.5	16	61.5	60	73.2
Taste sense disorder	18	32.2	7	26.9	25	30.5

No significant differences of clinical manifestations were found between the compared groups.

Polisorb MP was prescribed to patients in the form of an aqueous suspension within which the drug was stirred in 1/4-1/2 glass of water, ingested 1 hour before meals or other drugs. The dosage was calculated depending on the patient’s body weight and amounted to 0.1-0.2 g/kg body weight (6-12 g). Frequency — 3-4 times per day.

All observed patients received combined antimicrobial therapy including azithromycin. Patients with signs of intestinal dysfunction underwent bacteriological and virological stool examination. All of them received negative results.

RESULTS

Among the most frequent clinical symptoms of gastrointestinal dyspepsia recorded in patients with new coronavirus infection were dryness of the mucous membranes of the oropharynx (n = 60; 73.2%), persistent nausea (n = 57; 69.5%), pain in the epigastrium and upper abdomen (n = 38; 46.3%), as well as vomiting up to 3 times a day (n = 30; 36.5%), which was most often associated with coughing fits characteristic of the classic manifestations of coronavirus infection.

Nausea is a symptom recorded in all observed patients and in two thirds of cases nausea was identified on the constant basis, in 30% of cases it appeared sporadically. Vomiting was recorded in half of the patients (52.3%), bitterness in the mouth — in 46.4% of the patients. Only 6 patients (7.3%) complained of constipation, and this complaint was never a singular case – most often the patients complained of bitterness in the mouth and regurgitation.

Abdominal pain was recorded in more than half of the observed patients (68.3%), and most often the pain was localized in the epigastrium and in the upper abdomen, very rarely (4.9%) — in the lower parts. Liquid stools were found in every third patient (33.0%) with gastrointestinal disorders, and diarrhea most often developed sporadically. Every third patient admitted to an infection ward of the hospital had a change in taste perception or a complete loss of it. Changes in taste were mainly related to a decrease in the perception of sweetness and an increased sensitivity to salted products, i.e. most often patients added sugar to their food and believed that their food was too salty. The duration of this symptom could not be established since most often this symptom persisted after the patient was discharged from the hospital.

Group 1 patients were prescribed Polisorb MP for the treatment of dyspeptic disorders in accordance with the prescribing information of the drug. In the course of the treatment with the enterosorbent, the duration of disorder symptoms was significantly reduced (Table 2).

Thus patients receiving Polisorb MP complained of nausea on average 5.22 ± 1.36 days, while patients without enterosorption suffered from nausea for more than 9 days. Vomiting in patients of the 1st group was relieved 3 times faster — on average after 2 days. Regurgitation and heartburn persisted in the patients a little longer – up to 4 days. In patients of the control group these symptoms lasted up to 8 and 5 days respectively.

The longest symptoms in terms of duration were persistent bitterness in the mouth, abdominal pain and dryness of the mucous membranes of the oropharynx — about 7 days, but in patients who did not receive enterosorbents these symptoms lasted much longer — about 9 days.

Table 2

Characteristics of the duration of the main clinical symptoms of dyspepsia in patients with the new coronavirus infection

Symptoms	Duration of the symptoms (days)		p
	Group 1 (n=56)	Group 2 (n=26)
Nausea	5.22 ± 1.36	9.37 ± 2.44	p<0.05
Vomiting	2.16 ± 0.76	6.63 ± 1.15	p<0.05
Regurgitation	4.39 ± 1.02	8.57 ± 2.42	p<0.05
Heartburn	4.87 ± 0.55	5.42 ± 1.03
Bitterness in the mouth	7.51 ± 2.28	9.34 ± 2.31
Abdominal pain	6.44 ± 2.07	8.50 ± 2.00
Diarrhea	2.94 ± 0.46	7.19 ± 1.25	p<0.05
Dryness of the mucous membranes of the oropharynx	7.18 ± 1.04	9.13 ± 1.46

CONCLUSION

Dyspeptic disorders in patients with the new coronavirus infection occur in every third patient (32.2%), are always characterized by the appearance of nausea, often (73.2%) by dryness of the mucous membranes of the oropharynx accompanied by pain in the epigastrium and upper abdomen (46.3% ). Changes in taste (in 30.5% of patients with moderate and severe forms of infection) were mainly related to a decrease in the perception of sweet and an increased sensitivity to salted products.

The use of Polisorb MP in the comprehensive therapy of the new coronavirus infection in patients with gastrointestinal dysfunction significantly (p <0.05) reduces the duration of nausea, vomiting, regurgitation and diarrhea, which significantly improves the patients’ well-being and, most importantly, promotes adherence to the therapy.

REFERENCES

1. Supotnitskiy M. V. Novel coronavirus SARS-CoV-2 in the context of global epidemiology of coronavirus infections // Journal of NBC Protection
   Corps. — 2019. — V. 4. — №1. — P. 32—65. https://doi.org/10.35825/2587—5728-2020—4-1—32-65.

2. Xiao F., Tang M., Zheng X., Liu Y., Li X., Shan H. Evidence for gastrointestinal infection of SARS-CoV-2 // Gastroenterology. — 2020. DOI: https://doi.org/10.1053/j.gastro.2020.02.055.

3. Interim Guidelines: Prevention, diagnosis and treatment of the new coronavirus infection (COVID-19), 2020.

INFORMATION ON AUTHORS

Svetlana Nikolaevna Orlova – Doctor of Medicine, Professor, Head of the Department of Infectious Diseases, Epidemiology and Dermatovenereology, Federal State Budgetary Educational Institution of Higher Education Ivanovo State Medical Academy of the Ministry of Health of the Russian Federation; e-mail: orloff3.dok@mail.ru.

Oksana Valentinovna Dudnik — Candidate of Medical Sciences, Associate Professor of the Department of Infectious Diseases, Epidemiology and Dermatovenereology, Federal State Budgetary Educational Institution of Higher Education Ivanovo State Medical Academy of the Ministry of Health of the Russian Federation; e-mail: dudnik_oks@mail.ru.

Maria Aleksandrovna Kolosova — Assistant of the Department of Infectious Diseases, Epidemiology and Dermatovenereology, Federal State Budgetary Educational Institution of Higher Education Ivanovo State Medical Academy of the Ministry of Health of the Russian Federation; infectious diseases doctor, Regional Budgetary Healthcare Institution City Clinical Hospital No.1, Ivanovo; e-mail: maska-koks@mail.ru.

Sergey Evgenievich Lebedev — Assistant of the Department of Infectious Diseases, Epidemiology and Dermatovenereology, Federal State Budgetary Educational Institution of Higher Education Ivanovo State Medical Academy of the Ministry of Health of the Russian Federation; Board certified doctor in infectious diseases, Regional Budgetary Healthcare Institution City Clinical Hospital No.1, Ivanovo.

Zemskov Dmitry Ivanovich — infectious diseases doctor, head of the infectious diseases department, Regional Budgetary Healthcare Institution City Clinical Hospital No.1, Ivanovo.

Popilov Mikhail Andreevich — General Director of JSC Polisorb, Chelyabinsk Region, Kopeysk; e-mail: info@polisorb.com.

Enterosorption, a promising novel therapy, has effective uses in pediatrics. Enterosorbents can help treat a variety of diseases by binding and excreting various exogenous substances, microorganisms and the toxins they produce, as well as endogenous metabolites from the body. Enterosorbents are pharmaceuticals that have a high sorption capacity and do not disintegrate in the gastrointestinal tract (GIT); they are able to bind exogenous and endogenous substances contained in the chyme; they are released into the GIT cavity through its walls by absorption and adsorption, ion exchange, or complexing.

 Enterosorption is integral to efferent therapy (from the Latin efferens, ‘to remove’), which consists in treatments designed to nullify the effects of toxins of various origins and to eliminate them from the body. Beside enterosorption, efferent therapy methods include hemodialysis, peritoneal dialysis, plasmapheresis, hemosorption, etc.

Here are the key requirements to enterosorbents:

• no toxicity;

• no damage to the mucous membranes;

• an ability to evacuate completely from the intestinal tract;

• good functional (sorption) capacity;

• no resulting dysbacteriosis;

• a convenient dosage form.

Many different enterosorbents, both wood-based and chemically synthesized, are available and used in Russia. Polisorb MP is a domestic silica-based sorbent produced in Chelyabinsk Oblast; it meets all the above requirements and represents the best of enterosorbents.

Polisorb MP is a next-gen enterosorbent based on natural highly dispersed silica; it is capable of multifunctional nonselective sorption and is available as powder of particle size ranging from 5 to 20 nm.

Enterosorbents, including Polisorb MP, are designed to remove toxins of any origin from the body. Polisorb MP binds endogenous and exogenous toxins of various origin, including microorganisms and microbial toxins, antigens, food allergens, medications and poisons, salts of heavy metals, radionucleotides, and alcohol in the GIT lumen to further remove them from the body. Polisorb MP also sorbs some body metabolites, including excess bilirubin, cholesterol and lipid complexes, products of nitrogen metabolism, and medium molecular weight substances that contribute to metabolic toxicosis.

Indications for pediatric use of Polisorb MP 

• Acute intestinal diseases accompanied by diarrheal syndrome (dysentery, salmonelloses, bacterial food poisoning).

• Hepatitis of any etiology (viral, toxic, autoimmune).

• Endogenous and exogenous intoxication of any origin.

• Allergic reactions (drug and food allergies including angioedema, diathesis, dermatitis, psoriasis, bronchial asthma, obstructive pulmonary disease).

• Chronic kidney failure. 

Polisorb MP is not absorbed in the intestinal tract and naturally excretes from the body, hence virtually no contraindications for use. With few exceptions, the medication is not allergenic. Like other enterosorbents, Polisorb MP must be used with care when treating exacerbation of peptic ulcer disease and gastrointestinal tract hemorrhage.

Posology and administration

Therapeutic dosage is 100-200 mg / kg of body weight per day. The maximum permissible daily dosage is 330 mg / kg for short-term use. The sorbent is taken only in the form of an aqueous suspension.

To prepare an aqueous suspension, take the required amount of the medication (1 heaping teaspoon contains 1 g, and 1 heaping tablespoon contains 3 g of the powder), add 100 ml of water and stir thoroughly. Take the resulting suspension orally an hour before or 1-2 hours after a meal or intake of other medications.

Dosing Polisorb MP is generally not difficult. For adults, the average therapeutic dose is 3-4 tablespoons per day. For children, consult Table 1 to recalculate the dosage.

A.I. Grekova et al. carried out clinical trials of Polisorb MP in acute intestinal infections (AII) in children at Smolensk State Medical University. 

AII is one of the most common infections. 60% to 65% of all AII cases are registered in children, with a particularly high incidence in toddlers (up to 70%).

Literature review suggests the entirety of medical testing can detect the etiology in 56-80% of all cases; Salmonella, Shigella, Vibrio cholerae cause no more than 10% of intestinal infections in children in developed countries.

Rotavirus infection accounts for 9% to 73% of all AII cases, is diagnosed in 20% to 60% of all children hospitalized for intestinal disorders.

Novel etiopathogenetic medications and better AII therapy become imperative as the etiology and pathogenesis of AII in children change with viral diarrheas becoming more prevalent, whilst bacteria grow resistant to antibiotics, and ever more cases have adverse outcomes due to preexisting conditions.

Pathogenetic therapy of diarrhea-associated AIIs includes:

• detoxification;

• correcting fluid and electrolyte imbalance;

• correcting gastrointestinal motility and secretion disorders;

• correcting intestinal microflora disorders;

• reinforcing the mucosal reparation of the large intestine;

• enterosorption.

In case of an infection, enterosorption constitutes pathogenetic and etiological treatment, since sorbents are capable of both absorbing the endogenous and exogenous pathogenic toxins, and binding bacterial and viral pathogens to remove them from the process. The ability to bind endogenous and exogenous pathogenic toxins contributes significantly to detoxifying the body.

Russia’s pharmaceutical market offers a variety of enterosorbents: activated charcoal, lignins, ion-exchange resins; their clinical effects are diverse, and the organoleptic properties are sometimes unpleasant (hydrolyzed lignin). Solubility varies; often, there is an added fragrance, which might be critical for allergic children and may injure the intestinal mucosa. In light of the above, making novel enterosorbents

that meet the safety requirements, especially for pediatric use, remains a relevant undertaking.

Polisorb MP is a fine silica-based medication that meets all the basic requirements to enterosorbents: it is nontoxic, does not injure the GIT mucous membrane, evacuates easily, has great sorption and organoleptic properties.

The goal hereof was to test Polisorb MP in a clinical setting and to improve pathogenetic AII therapy in diarrhea-affected children.

Materials and methods: 65 pediatric inpatients were examined in 2005-2006 at Smolensk City Hospital No. 1, Unit 5 (Intestinal Infections). The clinical trial used hospital-collected data on intoxication (duration of nausea, emesis, loss of appetite), the severity of clinical manifestations (fever period, abdominal syndrome, duration of diarrhea, abnormal findings in stool contents), and laboratory findings (bacteriological and serological data on pathogen identification).

Children were split into two groups: Group A of 35 children on Polisorb MP administered in addition to conventional background therapy including specific antibacterial or antiviral treatment; Group B of 30 children with no Polisorb MP.

Table 1. Polisorb MP dosage chart
Aged <1	0.3–1 g per day
Aged 1-2	1–2 g per day
Aged 2-7	2–5 g per day
Aged 7-14	5–7 g per day
Aged >14, adults	7–20 g per day

WOMAN AND CHILD

 Age-wise, children aged 5 or younger were dominant in either group, see Fig. 1. Rotavirus infection was prevalent etiologically in both groups. Group A had 18 rotavirus-affected children (51.4%), Group B had 13 (43.3%), see Fig. 2. Moderate cases were prevalent in both groups, see Fig. 3.

Toxicosis assessment. Disappearance of intoxication symptoms reported on Day 4 in Group A, maximum extinction on Day 1 or 2; intoxication symptoms persisted up to Day 7, maximum extinction on Day 2 to 4 in Group B, see Fig. 4.

Table 2. Course of the disease
Criteria	Group А (n=35)	Group B (n=30)
Duration of fever response	2.8 days	3.2 days
Duration of nausea and vomiting	2.3 days	3.6 days
Duration of abdominal pains	2.5 days	3.8 days
Duration of diarrhea	3.2 days	4.3 days
Abnormal findings in stool contents (invasive diarrhea)	3.14 days	3.8 days
Average period of hospitalization	4.3 days	5.8 days

Course of the abdominal syndrome. The abdominal syndrome alleviated in the study group mainly by Day 3; it persisted up to Day 4 in 25% of Group B patients, see Fig. 5. Stool was formed by Day 3 in most patients in Group A, remained liquid in 3.3% in Group B until Day 8. Abnormal findings in stool contents reported up to Day 5 in Group B; no such findings reported in Group A by the end of Day 2 or 3, see Fig. 6. Course based on the data is shown in Tables 1 and 2.

In two cases of shigellosis in Group A (Shigella flexneri 2a isolated), post-treatment control fecal cultures were negative.

No rotavirus isolated in post-treatment stool tests of the 18 rotavirus-infected children (laboratory-confirmed).

Group B also had 2 cases of Shigella flexneri 2a; post-treatment fecal cultures negative.

5 out of the 13 rotavirus-infected children (laboratory-confirmed) tested positive for rotaviruses after treatment.

Each group had 15 cases of AII that were not laboratory-confirmed.

Adverse reactions and hypersensitivity to the enterosorbent not reported in this study.

Table 3. Laboratory data dynamics
Pathogen	Group A		Group B
	Pretreatment pathogen detection	Posttreatment pathogen detection	Pretreatment pathogen detection	Posttreatment pathogen detection
Shigella flexneri 2а	2	0	2	0
Rotavirus	18	0	13	5
Pathogen not detected	15		15

Thus, the collected evidence shows that:

1. Use of Polisorb MP in AII-affected children is associated with a faster recovery from intoxication symptoms, normalization of stool, and disappearance of abnormal findings compared to Group B.

2. Therapy delivered to Group A resulted in a better elimination of rotaviral pathogens from the intestines.

3. Therapeutically, Polisorb shortens the course of infection and allows discharging the patient sooner; the medication is cheaper than the alternatives, hinting at potentially better cost-effectiveness.

4. Enterosorption with Polisorb MP is recommendable for intoxication and diarrhea-accompanied AII in children.

Polisorb MP, an inorganic sorbent, effectively counters those.  It has unique sorption properties and does not have a resorption effect. Polisorb MP binds and removes many biologically active compounds (histamine, serotonin, bradykinin, etc.) to reduce the intensity of allergic tissue inflammation. This is how it alleviates allergies. ID, even subcompensated, often results in the presence of incompletely digested foods in the intestines. Those sustain clinical manifestations of food allergy, as they can be allergenic themselves; at the same time, direct irritation of the GIT mucosa they cause aggravates inflammation.

Polisorb MP has been used by the authors to treat 35 children in the Toddler Pathology Unit, 22 children in the Gastroenterology Unit, and 34 children in the Allergy Unit. The Toddler Pathology Unit mainly prescribed Polisorb MP treatment to children with acute allergic reactions (AAR) and ID. 19 (54%) children had AAR. 19 (54%) children had AAR. 10 of them (28.5%) had generalized urticaria; 5 (14.2%) had angioedema, and 4 (14.3%) had both. Notably, all the children received conventional, well-tested therapy (diet coupled with antihistamines, enzymes, biologicals, and hormones in severe cases). They were also prescribed Polisorb MP. A 3-5% aqueous suspension, 200 mg/kg/day was used until the clinical symptoms subsided. In general, a significant reduction in manifestations was noted on Day 2. Besides, novel allergic reactions (having manifested no earlier than the day before) tended to resolve faster. This might be due to the fact that Polisorb MP binds the incorporated allergen and removes it from the intestinal lumen before it can enter the bloodstream. Comparative retrospective analysis of 23 AAD histories from 1996 (before Polisorb MP came into use) showed that Polisorb-treated children would generally have their symptoms subside 3.8 ± 0.4 days faster on average than conventionally treated children. Only one child that had severe manifestations of food allergy (giant urticaria) had a significantly later recovery, although normally effective large-dose hormone therapy was not effective either. This might be a very specific case of AAR.

16 (45.7%) children had ID treated with Polisorb. The medication (3-5% aqueous suspension, 100 mg/kg/day) was prescribed upon admission for initial 7-10 days treatment on top of conventional therapy. Polisorb MP was taken 2 hours after a meal or intake of other medications. Where the disease relapsed, treatment was repeated after a two-week pause. ID was subcompensated in most cases: change in the quantity, and the emergence of altered strains of Escherichia coli; opportunistic flora identified in excess of 103 to 105 (staphylococcus, Klebsiella, Proteus, Candida, etc.) on top of reduced bifidobacterium flora. 6 (37.5%) children had unstable bowel movements, 10 (62.5%) had constipation. Posttreatment stool culture showed Polisorb MP to drastically reduce the presence of opportunistic flora (isolation rates dropped in 70% of cases) and altered E. coli (43%). However, bifidobacterium flora was reduced or totally zero in 80% of cases. That said, Polisorb courses must be followed by age-appropriate biologicals. Notably, the frequency and quality of bowel movements normalized in Polisorb-treated children.

The Gastroenterology Unit used Polisorb MP to treat ID in children with chronic enterocolitis. Whilst their bacterial tests differed from those of infants (higher isolation rates of opportunistic flora), the pattern was the same: faster elimination of pathogens and lack of bifidobacteria afterwards. Persistent opportunistic flora is typical of this condition. The results indicate Polisorb MP is a recommendable addition to the conventional treatment of chronic inflammatory bowel diseases.

The Allergy Unit treated older children with Polisorb. The medication was used in urgent AAR cases within a few hours upon admission. The results did not differ significantly from the effectiveness of Polisorb in younger children with similar conditions.

Thus, the inorganic sorbent Polisorb is effective for treatment of food allergies and ID. The effects described herein suggest Polisorb could have broader use in treatment of chronic inflammatory diseases of the GIT and allergies of various sensitization, as well as in comorbid cases.

References 

1. Enterosorbent Polisorb MP guidelines for clinical usage, Polisorb JSC, Chelyabinsk, 2007

2. Sovremenny vzglyad na problemu enterosorbtsii. Optimalny pokhod k vyboru preparata [A modern view of the problem of enterosorption. The optimal approach to the choice of drug] Ursova N.I., Gorelov A.V. Russian Journal No.19, 2006

3. Infektsionny toxikoz u detey [Infectious toxicosis in children] Uchaikin V.F., Molochny V.P. Moscow, 2002

Zhakov Ia.I. (2007) used Polisorb MP in the early age pathology unit (35 children), in the gastroenterological unit (22 children) and serum unit (34 children) of the children’s hospital. In the early age pathology unit, the course of administration with Polisorb MP was mainly received by children with acute allergic reactions (19 people) and intestinal dysbacteriosis (16 people). The results obtained allow for the conclusion that the enterosorbent Polisorb MP is a highly effective medication for the treatment of allergic diseases associated with food hypersensitivity, as well as intestinal dysbacteriosis [35].

101 children aged 2 to 7 years were examined by Stepanov O. G. et al. (2000). The observations show that Polisorb therapy exhibits the most prominent positive effect in the treatment of acute cases of food allergy, especially in patients with gastroenterological pathology combined with dysbiotic changes (shortening the hospitalization period by 3.8 days compared to children not receiving Polisorb). Other findings demonstrate the high efficiency of Polisorb in terms of opportunistic flora (isolation rate decrease in 70% of the cases) and E. coli with modified properties (43%) [36].

Khasanova R.B. (1997) included Polisorb MP in conventional treatment regimens for 28 patients with drug allergies. The control group consisted of 20 patients with drug allergies. Polisorb MP was prescribed for drug allergies from 5 to 15 days, depending on the severity of the clinical manifestations. Polisorb MP was the only medication for these patients in combination with fasting dietary treatment for a period of three days. With recurrent angioedema along with Polisorb MP, prednisolone was introduced into the treatment regimen at a dosage of 0.5 mg per 1 kg of the patient’s body weight in a decreasing regiment for five days. The recovery of eosinophils in the blood was determined for 4.5 ± 0.3 days (in the control after 7.8 ± 0.7 days) when analyzing laboratory findings. A statistically significant decrease in the IgE level was recorded in patients from the main group (p <0.05) in patients with drug allergy in the Polisorb MP group before discharge from the hospital. According to the results of the research, the authors documented and confirmed the high efficiency of the use of the medication Polisorb MP in urticaria, drug fever and eosinophilia [37]. 

Novikova L.A. et al. (2011) investigated the effectiveness of the complex therapy of toxicodermia using the enterosorbent Polisorb MP. The study included 36 patients with toxicodermia, 20 women and 16 men. The etiological factor was the intake of medications in 22 patients, including 6 — penicillin, 4 — ampicillin, 4 — erythromycin, 4 – biseptol and 4 — doxycycline. Food toxicodermia was reported in 10 patients and inhalation of dyes was the etiological factor in 4 patients. In the clinical picture, bullous eruptions were found in 4 patients, in 6 patients — vesicular eruptions, in 12 patients — papular eruptions and in 14 patients — erythematous squamous eruptions. Blood count parameters were determined with the calculation of Kalf-Kalifa leukocyte index of intoxication and level of medium molecular weight peptides. A leukocytosis reaction with medications was performed in 22 patients. Drug therapy was carried out with hyposensitizing agents — antihistamines. Polisorb MP was prescribed at a dose of 150-200 mg / kg / day (7-20 g per day). The sorbent was taken in the form of an aqueous suspension one hour before meals. The daily dosage was divided into three dosages. The duration of treatment was 5-10 days. All patients showed positive clinical dynamics expressed in a decrease in the area and intensity of inflammatory response of the skin. The use of the medication Polisorb MP in patients with toxicodermia caused a decrease in itching, the disappearance of vesicular and bullous, and deflorescence of spotted and papular eruptions. Prescription of Polisorb MP led to positive dynamics of endogenous intoxication indicators (leukocyte index of intoxication, medium-weight molecules), reduced the amount of drug therapy, and reduced the duration of treatment [38].

Ugleva T.N. et al. (1997) has studied the efficiency of Polisorb in 80 children aged from 1 month to 15 years with eczema and neurodermatitis and other skin allergological diseases in the acute stage at the Children’s Clinical Hospital. Polisorb was administered upon admission as the first therapy course. In some children, in cases of disease recurrence, repeated courses were used after a period of 2-3 weeks. The research results demonstrated high efficiency of using Polisorb in children suffering from skin diseases. Positive changes were observed in the majority of patients – as a decrease of hyperemia and infiltration in the skin and lesser severity of itching and oozing. The most significant clinical effect was observed in children with a short history of eczema and in the case of diffuse neurodermitis characterized by generalized skin lesions, long-term disease history, by the presence of polyvalent allergy and multi-organ lesions. The authors also noted the normalization of the frequency and nature of the bowel movement in patients using the medication Polisorb MP. The achieved positive clinical results persisted after discontinuation of the medication in the settings of following the hypoallergenic diet. In the majority of patients, improvements were observed in the results of feces analysis: decreased isolation rate and the number of opportunistic microflora and better survivability of bifido- and lactobacteria in cases of taking bacterial drugs [39].

The research conducted by Malikova M.S. (2013) included 40 patients of both genders aged 7 to 57 years with the following diagnoses: topic dermatitis of moderate severity– 20 patients (50%) and acute or recurrent urticaria — 20 patients (50%). The effectiveness of therapy was evalauted using the Scoring Atopic Dermatitis Index (SCORAD), according to which a higher score corresponds to a more severe disease severity. Before treatment the mean SCORAD scores in the main group of atopic dermatitis patients to the moment of treatment initiation was 47.3, while in the control group – 46.5 points. The decrease in the intensity of hyperemia, swelling, infiltration and itching in the main group was observed on the 6-7th treatment day (6.5 days), while in the control group – on the 9-10th treatment day (9.6 days). The SCORAD scores at the end of the first week were 30.2 and 36.4 points, respectively. By the end of the second week of treatment in patients from the main group, hyperemia and edema disappeared and the severity of infiltration and itching significantly decreased, but dry skin and peeling remained. In patients from the control group, hyperemia and infiltration persisted and itching was of moderate intensity. By the end of the second week of treatment, remission in the main group was found in 7 patients (70%), incomplete remission (remaining moderate skin dryness and exfoliation) – in 2 patients (20%) and one patient (10%) had persistent moderate itching. The SCORAD scores by the 14th day were 9.5. In patients with urticaria, the pruritis after using Polisorb persisted for 1.9 days, while in the patients of control group it persisted for 3.6 days; the urticaria elements in the main group persisted for 5.8 days with 9.1 days in the second group; the repeated rash onsets in the main group were found in 3 patients (30%) with 6 patients in the control group (60%) [40]. 

Bondar S.A. et al. (1992) conducted research which included 250 patients with eczema and 160 patients with psoriasis. As a result of the conducted comprehensive treatment, recovery was observed in 71% of patients with eczema and in 53% of patients with psoriasis, significant improvement was observed in 22% and 30%, respectively, improvement — in 5% and 17%, respectively and no changes were observed in 1% of patients, deterioration — at 1%. After the treatment, a decrease in the level of EMS was found: 0.289 ± 0.025 patients with eczema and 0.327 ± 0.018 in patients with psoriasis in the remission phase. There was a decrease in sorption capacity of red blood cells in patients with eczema to 38.1 ± 1.57%. Significantly higher indicators were found in the parameters of cellular and humoral immune response, in the activity of catalytic properties of myeloperoxidase and succinate dehydrogenase within the blood corpuscle, which indicates the applicability of introducing enterosorption therapy with Polisorb into the practical dermatological service for debridement of patients with eczema and patients with psoriasis. The authors also noted the high efficiency of Polisorb MP in the treatment of allergic state, including allergic dermatoses [41]. 

Pyatnitskaya S.A. et al. (2010) examined 100 children of both genders aged from 6 months to 15 years with the following diagnoses: acute or recurrent urticaria, atopic dermatitis and impaired purine metabolism with acetonemic vomiting. The authors selected 2 groups of children. Patients from the first group (n = 60) received Polisorb MP and children from the second group (n = 40) received other enterosorbents (Enterosgel®, activated charcoal). In patients with urticaria, the duration of persisting pruritus was statistically significantly lower in the course of therapy with Polisorb MP (1.7 days versus 3.4 days in patients from group 2, p <0.05), as well as the duration of preservation of urticaria skin elements (6.4 days versus 8.8 days, p <0.05), and the duration of eosinophilia (5.2 days versus 7.6, p <0.05). When discharging patients with atopic dermatitis the average value of the SCORAD scores decreased to a greater extent in children under Polisorb MP — from 58.7 to 43.2, while the value of this indicator decreased from 57.5 to 50.4 without the use of Polisorb MP. Eosinophilia duration in the course of therapy with Polisorb MP was lower — 7.8 days versus 9.1 days without the use of Polisorb MP (p <0.05). Thus, when using the medication Polisorb MP in children with urticaria, atopic dermatitis and purine metabolism disorders, faster resolving of disease symptoms and the normalization of the laboratory research methods results were reported, in addition, the use of the medication Polisorb MP shortens the hospitalization period for children [42].

Mitkovskaya O. A. (2014) in an open-label prospective comparative research studied the effectiveness of the use of the medication Polisorb MP for the treatment of allergic diseases in patients aged 15-50 years with moderate atopic dermatitis during a period of exacerbation. With a background of therapy with the studied medication, the author revealed an improvement in patients’ health, recovery of a normal lifestyle, a decrease in the pruritus and eruptions severity in 85% of patients and a decrease in the number of eosinophils in the blood and the level of interleukin (IL) -5, IL-4. No serious exacerbation of atopic dermatitis was observed when patients were under supervision for the period of 1 month after undergoing treatment [43].

Acute intestinal infections (AII) are very prominent in infectious pathology and are characterized by a high incidence and frequent development of post-infectious disorders. 

The problems associated with the reduction in the burden of acute intestinal infections and improving the outcome of their treatment are still relevant at the present time. Thus, adequately prescribed etiotropic and/or pathogenetic therapy can affect both the outcome and the duration of the disease.

Patients and methods:

Under our supervision, there were 97 patients with acute intestinal infections aged from 18 to 84 years, who were treated in the first infectious disease unit of the Municipal health care institution City hospital No. 5 in Barnaul. The vast majority of patients were admitted to the hospital in the first three days of the disease. Moderate and severe forms of the disease prevailed amongst all hospital patients — in 52 patients (53.6%) and a mild course of the disease was observed in 45 patients (46.4%). Clinical monitoring of patients was carried out daily from the moment of their admission to the hospital and until their discharge. In addition, all patients underwent general clinical research, coprological and bacteriological examination and serum diagnosis (HAI with salmonella and dysenteric antigens). The etiological deciphering of the diagnosis took place in 16.5% of cases. Salmonellosis caused by Salmonella enteritidis prevailed in 43.75% of cases among the deciphered diseases. Unspecified intestinal infections occurred in 81 patients (83.5% of cases). The patients were divided into 2 groups by random sampling technique and matched by sex, age and presence of concomitant somatic pathology. The main group «A» included 42 patients who received, along with etiotropic therapy (33 people), as part of a complex pathogenetic therapy (detoxification and rehydration therapy, enzyme preparations, pre- and probiotics), the medication «Polisorb MP» in a therapy dosage of 100-200 mg/kg of body weight per day (average dose — 2 grams 4 times a day). The course of the medication ranged from 2 to 7 days (an average of 3-5 days). The control group «B» included 52 patients, who received both etiotropic (43 patients) and pathogenetic therapy, with the exception of enterosorbents (Polisorb MP).

Results:

According to the severity of the course of the disease, moderate and severe forms prevailed in group «A» (moderate severity in 23 patients, severe in 2), in group «B» moderately severe courses of the disease were also observed (in 28 patients). Concomitant somatic pathology occurred in 14 patients of the main group (patients with chronic or acute non-infectious pathology of gastrointestinal tract, severe secondary immunodeficiencies, and oncology diseases were excluded from the research) and in 14 patients of the control group. Pathological admixtures in the bowel movement in patients of both groups were met with the same frequency (16% in group «A» and 17% in group «B»). Parenteral detoxification/rehydration therapy was prescribed (taking into account the peculiarities of the clinical course of the disease) to 24 patients of the main group and 26 patients of the control group. At the same time, the average duration of intravenous infusion was about 2.4 days in both groups. The duration of the conducted antimicrobial therapy ranged from 2 to 10 days and averaged 4.8 days in the main group and 5.2 days in the control group. It is important to note that the rapid recovery of body temperature in the study group (33 patients had fever). In the course of the treatment with Polisorb MP, the average number of days of fever was 1.7 days versus 2.3 days in the control group (40 patients had fever). It is also important to mention a more rapid disappearance of symptoms of gastric indigestion and a more rapid recovery of bowel movement consistency in group «A» (3.9 days of diarrhea); 4.1 days of diarrhea in group «B». The average hospitalization period was 6.7 patient days in the main group and 7.7 patient days in the control group. Moreover, by the time of discharge, residual effects occurred only in 2 patients from both groups: one patient retained a loose bowel movement (unauthorized leave from the department), and 1 patient retained a small admixture of mucus in the bowel movement.

Conclusion:

Our research has shown that the use of the enterosorbent «Polisorb MP» in the treatment of acute intestinal infections is characterized by high clinical efficacy. Thus, the use of Polisorb MP in the complex therapy of patients with AII leads to a decrease in the duration of symptoms of intoxication and diarrheal syndrome, helps to reduce the duration of antimicrobial therapy, and also reduces the hospitalization period, which is undoubtedly significant in the treatment of this patient population. The medication «Polisorb MP» can be recommended in the comprehensive treatment of patients with acute intestinal infections.

Witness: Deputy Chief Doctor /Signed/

/Sealed: Health care Committee of Barnaul city Administration

Municipal health care institution “City hospital No. 5” * OGRN 1022201767191/

Acute intestinal infections (AII) with severe diarrhea syndrome constitute a significant portion of hospitalized patients with infectious diseases, which necessitates the use of enterosorbents.
The aim: to analyze the effectiveness of the use of the Polisorb MP enterosorbent (active ingredient: colloidal silicon dioxide), in comparison with other enterosorbents, as a component of the treatment of acute
intestinal infections, using the time period for eliminating pain and dyspeptic syndromes as the comparative variable.
Material and methods. 62 cases of acute intestinal infections were analyzed in the Penza Regional Clinical Center for Specialized Medical Care. The diagnosis of AII was established on the basis of anamnestic and clinical data. The diagnosis was confirmed by bacteriological inoculation of feces, by PCR for the presence of genetic material of causative agents of acute intestinal infections. Statistical processing of research materials was carried out using methods of variation statistics.
Results. The use of the Polisorb MP as part of the comprehensive therapy of acute intestinal infections agents contributes to a more rapid regression of the clinical manifestations of the disease: the pain syndrome was
stopped, on average, within 1–3 days and the dyspeptic syndrome was stopped within 1–6 days (when using another enterosorbent, from 2 to 6 days and from 2 to 7 days, respectively).
Conclusion. Enterosorbent Polisorb MP is effective in adults and children in the treatment of acute intestinal infections of various etiologies and is convenient to use and safe.
Funding. The study had no sponsor support.
Conflict of interests. The authors declare no conflict of interests.
Contribution. The concept and design of the study – Krasnova L.I., Baranova I.P., Kurmaeva D.Yu., Popilov M.A.; collection and processing of material – Krasnova L.I., Dubinovskaya E.V.; statistical processing – Dubinovskaya E.V.; writing the text – Krasnova L.I., Baranova I.P., Dubinovskaya E.V.; editing – Baranova I.P.; approval of the final version of the article – Baranova I.P., Kurmaeva D.Yu.
For citation: Krasnova L.I., Baranova I.P., Dubinovskaya E.V., Kurmayeva D.Yu., Popilov M.A. Some features of the treatment of acute intestinal infections in adults and children. Infektsionnye bolezni: novosti, mneniya, obuchenie [Infectious Diseases: News, Opinions, Training]. 2020; 9 (4): 92–7. DOI: https://doi.org/10.33029/2305-3496-2020-9-4-92-97 (in Russian)
Received 07.10.2019. Accepted for publication 09.11.2020.

Keywords: acute intestinal infections, treatment, enterosorbents, Polisorb MP (Silicium dioxide colloidal)

Acute intestinal infections (AII) constitute a significant part of infectious pathologies and represent one of the major causes of disease and death in developed and developing countries [1, 2]. According to the official data, 754 cases of AII [3] were registered in Penza region as of February, 2019. With intestinal diseases on the rise and strengthening resilience of intestinal infections agents to antibacterial drugs. As such, using the method of enterosorption remains at the forefront of disease treatment [4]. The growth of viral intestinal infections with a pronounced diarrhea syndrome represents the facet of the issue that requires the use of enterosorbents. However, most of them have a necessary therapeutic effect only in large doses (up to 100 g/day), causing a disorder of the morphofunctional state of intestinal tract [5]. The distinctive feature of Polisorb MP is that the silicon dioxide molecule constituted in a colloidal suspension does not have a crystalline structure and does no damage to the mucous membrane of gastrointestinal tract. The drug creates a suspension and does not flake for up to 60 hours and has a high level of dispersion, which strengthens its effectiveness a hundred-fold when compared to traditional carbon sorbents. Wall effects of Polisorb MP resembling the effects of coating medications are beneficial as well. Gluing together microbial bodies, Polisorb MP blocks their vital activity showing its bacteriostatic properties. Production of the drug corresponds to the GMP standards [6].

The aim – to analyze the effectiveness of the use of the Polisorb MP enterosorbent (active ingredient: colloidal silicon dioxide), in comparison with other enterosorbents, as a component of the treatment of AII, using the time period for eliminating pain and dyspeptic syndromes as the comparative variable.

Material and methods

62 cases of the disease were analyzed. A prospective controlled clinical study was carried out in 2019 in the infection ward No. 4 located on the basis of the Penza Regional Clinical Center of Specialized Types of Medical Care. The infection ward has 43 beds and is intended primarily for the treatment of patients with acute respiratory infections in children from the age of 5 and adult patients.

AII was diagnosed on the basis of anamnestic, clinical data, as well as complaints of weakness, pain in the epigastrium and along the intestinal tract, repeated vomiting, frequent liquid stool, fever and clinical data (dehydration, intoxication, loss of appetite, vomiting, dry tongue and lips, painful palpation of the abdomen in the epigastric region and along the intestinal tract, liquid stool).

The diagnosis was confirmed by clinical analysis, biochemical blood test (possible increase of urea and creatinine with the amylase levels in the norm), clinical urine analysis (high specific gravity, presence of protein, blood corpuscles, ketones), coprological test (increased amount of neutral fat, soap, white blood cells in large quantities, mucus, erythrocytes), bacterial culture test (pathogens of bacteria of the intestinal group), inoculation of feces by polymerase chain reaction (PCR) method for the presence of genetic material of causative agents of acute intestinal infections (rotaviruses, noroviruses, astraviruses, adenoviruses, shigella, salmonella, campylobacter) using the «Screening of acute intestinal infections … Determination of DNA (RNA) Shigella spp., E. coli (EIEC), Salmonella spp., Campylobacter spp., Adenovirus F, Rotavirus A, Norovirus 2 genotype, Astrovirus [real-time PCR] » test system; the results of ultrasound examination of the abdominal organs, kidneys and, if necessary, X-ray of the abdominal organs (in order to exclude the structural pathology of the organs of the gastrointestinal tract and acute intestinal obstruction).

Polisorb MP (active ingredient: colloidal silicon dioxide) was tested as an enterosorbent in a comprehensive therapy with the assessment of its effectiveness in AII patients as compared to other enterosorbents. The drugs were prescribed as a 6-day course in accordance with the age and weight categories of the patients.

Polisorb MP was prescribed in accordance with the instructions for use, in the form of an aqueous suspension administrated orally 3 times per day, i.e. the powder was mixed in 1/4–1/2 glass of water, depending on the body weight (Table 1).

The study included 62 patients with AII that manifested in the form of gastritis, gastroenteritis, enteritis or colitis syndromes. Gender-wise, the study included 39 females and 23 males. 32 patients were children from the age of 3 and 30 patients – adults (Tables 2 and 3).

All patients were divided into 2 groups: comprehensive therapy of the first group patients included Polisorb MP enterosorbent – 21 monitored patients; patients of the second group received another enterosorbent (activated carbon) – 41 monitored patients (Table 4).

In 11 (17.74%) patients the etiology of the disease was established bacteriologically; in 11 (17.74%) cases – using PCR diagnostics, in 40 (64.52%) cases the etiology of AII was not identified.

Statistical processing of research materials was carried out using methods of variation statistics and the determination of the reliability indicator (p <0.05).

Table 4. Etiological structure of verified acute intestinal infections (AIIs)

AII etiology	Polisorb MP	Activated carbon	Overall
Not identified	19	21	40
Staphylococcus	—	6	6
Salmonella	1	—	1
Norovirus	—	3	3
Mixed infection caused by a rotavirus or a norovirus	—	2	2
Shigella flexneri	—	3	3
Rotavirus	1	6	7
Total	21	41	62

Ingested as a water suspension an hour before or an hour after a meal and ingesting other medicaments.

Results and discussion

Assessment of the effectiveness of the use of enterosorbents with reference to the relief of pain and dyspeptic syndromes is given in Table 5. The average period of pain relief in patients with AII when using Polisorb MP was found to be 1.4 (from 1 to 3) days, when using another enterosorbent — 4.3 (from 2 to 6) days (p <0.001). The period of relief of dyspeptic syndrome exceeded the period of pain relief in both groups and averaged 2.1 (from 1 to 6) days when using Polisorb MP and 4.7 (from 2 to 7) days when using other enterosorbents (p <0.001).

Table 5. Periods of pain relief and the relief of dyspeptic syndrome in analyzed groups (the use of Polisorb MP enterosorbent, the use of another enterosorbent)

Syndrome	Period of relief of the assessed syndromes, days		p
	Polisorb MP	Activated carbon (2nd group)
Pain	1.4	4.3	<0.001
Dispeptic	1.2	4.7	<0.001

According to the obtained data the administration of Polisorb MP as part of the comprehensive therapy of AIIs of various etiologies led to a rapid regression of clinical manifestations of the disease: pain and dyspeptic syndromes during therapy with Polisorb MP disappeared much faster (by more than 2 times). This contributed to the reduction in the duration of hospitalization and, consequently, disability of the population. All patients noted the acceptability of the drug and its ease of use, since Polisorb has no taste or smell and does not stain fecal matter with a dark color as charcoal does, which allows patients to better monitor their condition. Having analyzed the effectiveness of the use of the enterosorbent Polisorb MP as compared with other enterosorbents, we can assume a pronounced sorption effect of the drug, which makes it possible to recommend it to patients with AII as part of a comprehensive therapy.

Conclusion

The use of Polisorb MP as part of the comprehensive therapy of acute intestinal infections of various etiologies led to a rapid regression of pain and dyspeptic syndromes by more than 2 times, which contributed to a reduction in the duration of hospitalization and disability of the population. Polisorb MP is effective in treating AII of various etiologies in adults and children. The use of the Polisorb MP enterosorbent is safe as it has no smell and taste, which increases the adherence to the treatment of AII on the part of patients.

AUTHORS

Lydmila Ivanovna Krasnova — Candidate of Medical Sciences, Associate Professor, Senior Lecturer of the Department of Infectious Diseases of Penza Institute for Advanced Training of Doctors — branch of the FSBEI FPE RMACPE MOH Russia, Penza, Russian Federation

E-mail: lik72@list.ru

Irina Petrovna Baranova – Doctor of Medicine, Professor, Professor of the Department of Infectious Diseases of Penza Institute for Advanced Training of Doctors — branch of the FSBEI FPE RMACPE MOH Russia, Penza, Russian Federation

E-mail: irinapetrovna.baranova@yandex.ru

https://orcid.org/0000-0002-3692-8359

Elena Vladimirovna Dubinovskaya — Assistant of the Department of Infectious Diseases of Penza Institute for Advanced Training of Doctors — branch of the FSBEI FPE RMACPE MOH Russia, Penza, Russian Federation

E-mail: d.e.v.1991@yandex.ru

Dzhamilya Yusupovna Kurmaeva — Candidate of Medical Sciences, Deputy Chief Physician for the Medical Department of the State Budgetary Healthcare Institution Penza Regional Clinical Center of Specialized Medical Care, Freelance Chief Infectious Disease Specialist of the Ministry of Health of Penza Region, Penza, Russian Federation

E-mail: d.kurmaeva@yandex.ru

Mikhail Andreyevich Popilov — General Director of JSC Polisorb, Chelyabinsk Region, Kopeysk, Russian Federation

E-mail: info@polisorb.com

https://orcid.org/0000-0001-8786-8635

REFERENCES

1. SP 3.1.1.3108-13 «Prevention of acute intestinal infections». (in
   Russian).

2. Men’shikova S.V., Ketova G.G., Popilov M.A. Diarrhea of various etiologies. Polisorb MP as a new solution to an urgent problem. Glavniy vrach
   Yuga Rossii [Chief Physician of the South of Russia]. 2017; 3 (56): 29–34.
   (in Russian).

3. Penza State Sanitary and Epidemiological Surveillance Center, official website. URL: http://medfirms.ru/firm41067.html

4. Kulmagambetov I.R. Modern approaches to the control and containment of antibiotic resistance in the world. Mezhdunarodniy zhurnal prikladnikh i fundamental’nikh issledovaniy [International Journal of Applied and Fundamental Researches]. 2015; (9): 54–9. (in Russian).

5. Men’shikova S.V., Popilov M.A., Ketova G.G. Alternative solutions to the
   pressing problems of modern medicine. Zhurnal mezhdunarodnoy meditsiny
   [Journal of International Medicine]. 2017; 1 (24): 54–8. (in Russian)

6. Men’shikova S.V., Ketova G.G., Popilov M.A. The use of enterosorbent Polisorb MP (colloidal silicon dioxide) in the complex treatment of various pathological conditions in children. Sovremennye problemy nauki I obrazovaniya [Modern Problems of Science and Education]. 2016; (6): 184. (in Russian)

Comprehensive preventive measures contributed to the significant decrease of diseased diagnosed with acute intestinal infections (AII). However, intensification of migrating processes, spreading of public catering services, poor quality of water in many regions of Russia and other countries lead to AIIs that still constitute a large part of infectious pathologies. One of measures designed to reduce the number of AII cases is a balanced and effective therapy for all patients.

The main area of focus of pathogenetic therapy for AII is detoxification. Enterosorption is a non-specific detoxification method that binds and removes toxins from the gastrointestinal tract. Polisorb MP is a new generation enterosorbent created on the basis of highly dispersed silica; it has polyfunctional non-selective sorption properties; is available in the form of a powder with a particle size of 5 to 20 nm. The modern pharmaceutical market has a wide variety of enterosorbent preparations.

We have carried out a comparative study of the effectiveness of different enterosorbents when treating AII. The study included 88 patients with the cases of bacterial food poisoning and salmonella (40 women and 48 men) aged 17 to 70 years.

Depending on the treatment method the patients were divided into 4 groups: in the 1st patients (n = 50) received Polisorb MP as an enterosorbent at a dose of 9 g/day, in the 2nd (n = 14) — activated carbon — 6 g/day, in the 3rd (n = 13) – the «Filtrum» medicine — 3.2 g/day, for the 4th group (n = 11) enterosorbents were not prescribed. The groups were matched by gender, age of patients and the presence of concomitant diseases (patients with concomitant gastrointestinal diseases and immunodeficiency states were excluded from the study). All patients received rehydration therapy (infusion or oral) and polyenzymes. The effectiveness of treatment was assessed by the rate of disappearance of the main symptoms of the disease (fever, diarrhea, vomiting).

The 1st group (25 men and 25 women aged 17 to 67 years) included 40 patients with the cases of bacterial food poisoning and 10 patients with salmonellosis. The diagnosis of bacterial food poisoning in 16 cases was verified by isolating St. aureus from gastric lavage; in other cases, it was determined by clinical means. Patients had a past history of eating expired salads, mushrooms, and cooked sausages. The diagnosis of salmonellosis in all cases was confirmed bacteriologically (isolation of S. enteritidis). Bacterial food poisoning in 32 cases progressed in a moderate form, in 5 patients there was a mild progression, in 3 patients — severe with pronounced dehydration. The course of salmonellosis in all cases was moderate with grade II dehydration. In the first 24 hours after the onset of the disease, 30 (60%) patients were admitted to the hospital, another 10 (20%) patients — on the 2nd day and the rest were hospitalized on the 3-4th day of the disease.

Polisorb MP at a dose of 3g 3 times a day was prescribed from the 1st day of hospitalization; the duration of treatment was 2–5 days (depending on the duration of diarrhea; on average 3.8 days). Diarrheal syndrome persisted on average 3.6 days (from 1 to 7 days), fever lasted from 1 to 6 days (average 2.1 days) and vomiting in all patients stopped on the day of hospitalization. The duration of hospital stay was 6.0 days.

In the 2nd group (10 men and 4 women aged 20 to 68 years) all patients were diagnosed with the moderate case of bacterial food poisoning. The diagnosis was verified by isolating the St. aureus culture in 3 patients. Patients of the 2nd group were hospitalized on the 1st – 3rd day of the disease; on the day of admission to the hospital, they were prescribed activated carbon as an enterosorbent in a daily dose of 6g.

The duration of diarrhea in patients of this group ranged from 1 to 5 days (on average 3.9 days), the duration of fever — from 1 to 4 days (on average 2.2 days) and the duration of hospital stay — on average 6.3 days.

In the 3rd group (7 women and 6 men aged 18 to 60 years), the patients were diagnosed with mild and moderate cases of bacterial food poisoning, and they received Filtrum as an enterosorbent at a dose of 0.8g 4 times a day for 4-5 days from the moment of admission to the hospital (1-3rd day of the disease). The duration of diarrhea in these patients was 4.6 days, the duration of the fever was 3.5 days, and the hospital stay was 8.3 days.

Patients of the 4th group (4 women and 7 men, aged 25 to 58), who did not receive enterosorbents, constituted the control group. All patients in this group were diagnosed with moderate bacterial food poisoning.

Diarrheal syndrome persisted in this group from 1 to 7 days (on average 4.0 days), fever — 2.5 days (from 2 to 3 days; in 2 patients, the body temperature did not increase) and the duration of hospital stay was 6.9 days (from 3 to 13 days).

Thus, the results of the study showed that enterosorption is an effective and necessary method of treating AII. When Polisorb MP was included in the treatment regimen, the duration of hospital stay, the duration of fever and diarrhea were significantly shorter than in the control group. The lack of significant differences in the timing of the recovery of patients in this and the 2nd group possibly appeared due to the earlier hospitalization of the latter. With the prescription of Polisorb MP, the duration of fever, vomiting and hospital stay was significantly shorter than in patients of group 3; in our study, Filtrum had no effect on the course of the infectious process.

The Polisorb MP medicine can be recommended for inclusion in the standards of medical care for bacterial food poisonings and salmonellosis.

POLISORB MP – EFFECTIVE MULTIPURPOSE ENTEROSORBENT Polisorb MP (medical, oral) is an inorganic, non-selective enterosorbent based on highly dispersed silica. Due to its non-porous surface Polisorb MP has a high adsorption rate (1–4 min). With prompt initiation of treatment in infection practice (bacterial food poisonings and AIIs) the duration of treatment is significantly reduced. Due to the adaptogenic action of the medicine the organism’s resistance to adverse environmental conditions and infections increases. Polisorb MP is used as a radioprotective agent in low radiation conditions. Specifics of use of Polisorb MP when treating various diseases: Bacterial food poisoning and acute poisoning. It is recommended to start therapy with gastric lavage with 0.5-1% suspension of Polisorb. In the case of severe poisoning on the first day, gastric lavage is carried out via a probe every 4-6 hours. In addition, the medicine is given orally. The dose in adults can be 100-150 mg/kg of the patient’s body weight 2-3 times a day. Acute intestinal infections. It is recommended to start treatment with Polisorb in the first hours or days of the disease in combination with other methods of treatment. On the first day, the daily dose is given for 5 hours with 1-hour intervals between doses. On the second day the daily dose is divided into 4 doses administered during the day. Duration of treatment is 3-5 days. Treatment of viral hepatitis. In the comprehensive therapy of viral hepatitis, Polisorb is used as a detoxifying agent in usual doses during the first 7-10 days of the disease. Allergic diseases. In case of acute allergic reactions of drug or food origin, preliminary gastric and intestinal lavage with 0.5-1% suspension of Polisorb is recommended. After that, the drug is administered in usual doses until the onset of the clinical effect. For chronic food allergies, Polisorb courses are recommended for 7-15 days that the medicine is ingested immediately before meals. Similar courses are prescribed for acute recurrent urticarial fever and Quincke’s edema, eosinophilia, before and during the course of pollen allergy and other atopy aggravations. Chronic kidney disease — CKD (azotemia). The prescribed course of treatment with Polisorb is: a daily dose of 150-200 mg/kg of body weight for 25-30 days with a 2-3-week break. The combination of enterosorption with hemosorption can reduce the rate of CKD progression and delay the onset of chronic hemodialysis by up to 8 months. Polisorb MP is non-toxic, has no age restrictions and is thermal and lightproof. In 2005 Polisorb MP was patented for the use as a means with a membrane-stabilizing effect, which makes it possible to use it as a monotherapy in the treatment of a large number of diseases. CJSC Polisorb     www.polisorb.ru      Registration certificate of the Ministry of Health of the Russian Federation P No. 001140/01 – 2002. Patent No. 2253459

Acute infectious diarrheal diseases (AIDD) in children remain both a recent and prominent public health issue. The patterns of AIDD has changed in the recent years. Viral diarrhea is predominant (up to 70%), the main clinical sign of which is gastroenteritis syndrome. A syndrome of the same nature occurs in a number of bacterial infections, mainly caused by Escherichia, as well as by opportunistic flora. According to the modern approach to the treatment of diarrhea, the attitude towards antibacterial therapy, which is recommended only for enteroinvasive infections, has changed. Antiviral agents are being introduced to treat viral diarrhea. At the same time, enterosorption is one of the most effective types of etiopathogenetic therapy. New generations of modern enterosorbents appear in the medical practice such as Polisorb MP.

Goal of the research: To carry out a comparative evaluation of the efficacy of the new generation sorbent Polisorb and Smecta, which was the chosen alternative medication for AIDD treatment.

Two groups of patients with AIDD were taken. The 1st group consisted of 26 patients, in whose complex treatment Polisorb was used; The 2nd group consisted of 20 patients receiving Smecta. The two groups of patients with AIDD were randomly selected. The 1st group consisted of 26 patients, in whose comprehensive treatment Polisorb was used; 2nd group consisted of 20 patients receiving Smecta. The age of the patients in both groups varied from 1 to 3 years, both groups were comparable in terms of the severity of a disease: the moderate-severe form was mainly observed. Efficacy was evaluated according to the duration of the fever and the duration of the diarrhea syndrome. The average duration of fever in the 1st group was 1.83 days and in the 2nd group — 2.05 days. The duration of diarrheal syndrome in the 1st group was 1.59 days and in the 2nd group — 2.9 days. The duration of diarrhea syndrome in the 1st group was 1.59 days and in the 2nd group — 2.9 days. With OIDD of viral etiology in the 1st group and the 2nd group, the period of fever was 2.0 ± 0.29 and 2.1 ± 0.31, (p = 0.53), with bacterial diarrhea 2.21 ± 0.26 and 3.1 ± 0.59 days, respectively (p = 0.11). The difference in both etiological groups is not statistically significant. The duration of diarrhea in viral AIDD was 1.5 ± 0.22 and 2.2 ± 0.25 days. (р = 0.051), bacterial – 1.68 ± 0.34 and 3.6 ± 0.64 days (р = 0.0077) – a significant statistical difference.

Conclusion. No differences in the duration of fever were revealed after using Polisorb and Smecta in the complex therapy of AIDD. At the same time, Polisorb was more effective in alleviating diarrhea syndrome in both viral and bacterial AIDD. In addition, there was a better tolerance of Polisorb as there was no nausea and vomiting, which were observed with the use of Smecta. Conclusively, there was a better tolerance of Polisorb, without nausea and vomiting, which were observed with the use of Smecta.

(Proceedings of the 5th Annual All-Russian Congress on Infectious Diseases, Moscow, March 24-26, 2014 http://www.congress-infection.ru/Tezisi IB2014.pdf p.106)

S.N. Elovikov investigated the efficiency of the use of Polisorb MP in narcological practice for the relief of drug and alcohol abstinence. The use of Polisorb MP in the comprehensive therapy of patients with alcohol and drug abstinence was carried out on the basis of a neuropsychiatric hospital, as well as on the basis of an emergency drug treatment team, an anonymous office and a day hospital, where only alcohol abstinence syndrome was treated. Polisorb MP was prescribed up to 4 g 4 times a day for 5 days in case of alcohol abstinence syndrome and up to 10-12 days in the same doses in case of opium abstinence. For all patients enterosorption was performed in the course of basic drug detoxification and psychotropic therapy. The course of treatment was carried out in 183 patients with chronic alcoholism and 32 patients with opium addiction. Based on the experience of using Polisorb MP, the author came to the conclusion that it is advisable to include this medicine in the comprehensive therapy of abstinence conditions. 

Based on the study of M.K. Vishnevetsky  et al. (2017) high efficiency and gastrointestinal sorption capacity of Polisorb MP in the case of drug poisoning was established. The study was carried out on the basis of the toxicological center of the city ambulance station in Perm. The study included 3 groups: comparison group (n = 175), group 2 with patients that received Polisorb PM at the hospital stage (n = 107) and group 3 with patients that received Polisorb MP at the prehospital stage with continued administration of the drug in the hospital (n = 53). At the prehospital stage, enterosorbent was injected into the stomach through a tube at the rate of 14 g per 150 ml of water. After a 10-minute exposure, the stomach was lavaged until lavage water was clean and Polisorb MP was re-administered at a dose of 30g per 150 ml of water. In the hospital, Polisorb MP was prescribed in the dose of 4–5 g every 4–6 hours for 2–5 days. The average daily dose of the sorbent was 30 g. The results revealed that the use of Polisorb MP at the prehospital stage and in the hospital had a positive effect on the course of poisoning, a decrease in the incidence rate of pneumonia was observed by 1.6 times, the cardiotoxic effect by 1.3 times, and the duration of hospitalization by 2–2.5 times.

After the administration of Polisorb MP, an improvement in the clinical condition was noted within the first hours; all patients left the toxigenic phase of poisoning. No deaths in the study group were recorded. A decrease of the hospital stay was noted in those patients who were included in the main study group.

N.Kh.Khafizov et al. (2000) investigated the efficiency of the use of Polisorb MP enterosorbent in the treatment of alcohol abstinence syndrome. The authors observed 250 patients (218 men and 32 women), aged between 16 and 70 years, who received detoxification therapy using Polisorb MP for 1 to 5 days. All patients were admitted to the center for the treatment of acute poisoning with a diagnosis of alcohol abstinence syndrome. Enterosorption was performed in the course of symptomatic drug therapy, the volume of which corresponded to the degree of intoxication and abstinence. Polisorb MP was used at a dose of 5 g per reception 3 times a day until the relief of abstinence symptoms. The condition of patients was assessed by clinical and functional indicators. An improvement in the condition of patients, normalization of the functions of the respiratory and cardiovascular systems and a decrease in the severity of withdrawal symptoms were noted. Studies have shown that Polisorb MP is effective depending on the severity of alcohol abstinence syndrome, the presence of concomitant chronic gastrointestinal diseases, and it can be successfully used in the treatment of patients with alcohol abstinence symptoms. 

N.A. Karpun et al. conducted a clinical testing of the Polisorb MP enterosorbent, which was used in the preparation of 10 patients with heroin intoxication to perform anesthesia-assisted pharmacological detoxification. The control group consisted of 14 patients with heroin addiction without the use of enterosorption. After the patient was under the effect of anesthesia, with intubated trachea and transferred to artificial ventilation, a probe was inserted into the stomach and an aqueous suspension of the drug was injected. Polisorb MP was administered in a daily dose twice with a 2.5 hour interval between the administrations. At the end of anesthesia-assisted pharmacological detoxification, the probe was removed in the course of active aspiration of gastric contents. Compared with the control group, patients who received Polisorb MP have shown no sign of dyspeptic disorders (nausea, vomiting, frequent loose stools); 100% of patients had a negative test for the presence of opioids in the urine at the end of the anesthesia-assisted pharmacological detoxification (while in the control group this test was positive in 30% of patients), which made it possible to speak of adsorption and elimination of some of the heroin from the gastrointestinal tract.

(R.V. Popova et al. 2018) conducted an assessment of extraintestinal manifestations of the norovirus infection among children. The study included 80 children hospitalized in the pediatric infectious disease unit. Norovirus etiology was confirmed via polymerase chain reaction (PCR) method. The authors assessed clinical symptomatology, laboratory examination results, ECG, echocardiography (EchoCG), ultrasonic investigation (ultrasonography) of the abdominal organs and kidneys. The most prevalent of the observed extraintestinal clinical manifestations (34% of patients) is rhinopharyngitis. According to the ECG and EchoCG results, abnormalities were found in 71% of children, changes in pancreas in 53%, changes of liver in 46%, and changes in kidneys in 38%. Extraintestinal symptoms of the majority of patients were alleviated within 18-25 days. However, the ECG and EchoCG of 2 children still showed said abnormalities, 8 children (19%) still had pancreas swelling, 11 children (29%) had abnormalities of their parenchyma and 6 children (16%) had hepatomegaly. The authors concluded that typical gastrointestinal symptoms of a norovirus infection in children are in many cases followed by the signs of disturbance to the hepatobiliary system, pancreas, upper respiratory tract, kidneys and heart in the infection-inflammatory process. Active and prompt comprehensive therapy lowers the frequency of development, longevity and severity of the major symptoms extraintestinal manifestations. The authors concluded that the most efficient medicine for treatment of a norovirus infection was colloidal silicon dioxide (Polisorb MP). 

L.V. Belokonova et al. (2017) investigated the efficiency of modern enterosorbent treatment of moderate rotavirus gastroenteritis in children. The study included 120 children, aged between 0-5 years. All patients were receiving background therapy as part of the standards for providing specialized medical care that included a balanced diet, rehydration therapy, enzyme preparations and probiotics; symptomatic therapy was performed as clinically indicated. Patients of the first group (n = 40) were receiving Polisorb MP enterosorbent in addition to the background therapy in doses based on their age. The patients received treatment for 5 days. Patients of the second group (n = 40) were receiving dioctahedral smectite in addition to the background therapy, and patients of the third group (n = 40) were receiving activated carbon. All patients were examined in accordance with the standards for providing specialized medical care to patients. Laboratory tests included a complete blood test, a clinical urine test, a stool test, a bacteriological stool test for the presence of coliform bacteria, campilobacteriosis, typho-paratyphoid group and coprofiltrate examination for the presence of rotavirus antigen in an AIE reaction. Re-examination of coprofiltrate for rotaviruses was performed on the 4th – 5th day from the beginning of treatment. If the AIE result was positive upon re-examination, it was recommended to extend the course of administration of Polisorb MP for 5 more days with a subsequent verifying detection of a rotavirus antigen in fecal matter 5 days after the patient had been dismissed.

Therapy efficiency was assessed by the length of the acuity of a disease: time of alleviation of fever, intoxication, end of vomiting, diarrhea and tympanites (Table 2).

Table 1 Average length of clinical symptoms depending on the received therapy among children with moderate rotavirus gastroenteritis 

Clinical symptom	First group	Second group	Third group
Fatigue	2.34 ± 0.153	2.28 ± 0.193	2.95 ± 0.21,2
Reduced appetite	2.22 ± 0.113	1.90 ± 0.173	3.10 ± 0.221,2
Vomiting	1.68 ± 0.223	1.54 ± 0.153	2.65 ± 0.21,2
Tympanites	2.35 ± 0.113	2.23 ± 0.143	3.12 ± 0.11,2
Fever	2.56 ± 0.263	2.40 ± 0.143	3.35 ± 0.151,2
Diarrhea syndrome	2.88 ± 0.173	2.80 ± 0.193	3.85 ± 0.141,2

Note: superscript is used to show groups, differences between which are statistically significant (p < 0.05).

Thus, the inclusion of Polisorb MP enterosorbents or dioctahedral smectite in the background therapy had a quicker and more prominent detoxifying, hypothermal and antidiarrheal clinical effect than when using activated carbon (p < 0.05 in each case).

With the use of Polisorb MP, the rotavirus antigen was detected in coprofiltrate on the 4th-5th day in 45% of the patients, in second group on the 4th-5th day coprofiltrate test results were positive in 40% of the patients, in the third group — in 65% of the patients. 9 convalescents who continued ingesting Polisorb MP were examined 5 days after dismissal, as well as 8 convalescents who were administered dioctahedral smectite and 10 children who were ingesting activated carbon. 1 convalescent from the first group, 1 from the second and 6 convalescents who were ingesting activated carbon had shown positive EIA results. Thus, no statistically significant differences in the sanitizing effect of Polisorb MP and dioctahedral smectite when treating rotavirus infections were detected (p > 0.05). After the dismissal of children that had a rotavirus gastroenteritis from hospital, part of convalescents continued to emit rotaviruses in the atmosphere creating a big epidemiological risk despite their clinical recovery and stool improvement. That is why using Polisorb MP as part of the comprehensive therapy of a rotavirus infection in children significantly reduces the time required for virus elimination with bowel movement and consequently reduces the number of rotavirus carriers among convalescents, thus improving the epidemiological situation within child groups.

E.V. Diachuk  et al. (2011) performed a clinical assessment of the efficiency of Polisorb MP in a comprehensive therapy. The study included 97 patients hospitalized with acute intestinal infections, aged between 18 and 84 years. The majority of patients were hospitalized during the first three days of the disease. The predominant forms of disease among the patients were moderate and severe – in 52 patients (53.6%), while a mild form was registered in 45 patients (46.4%). The patients were monitored on a daily basis from the moment of hospitalization and until their dismissal. Moreover, general clinical studies, coprological and bacteriological examinations, serum diagnosis (reaction of indirect hemagglutination with salmonella and dysentery antigens) were performed for all patients. Etiological interpretation of the diagnosis was performed in 16.5% of the cases. The predominant diagnosis among the confirmed cases was salmonellosis caused by Salmonella enteritidis – in 43.75% of the cases. Intestinal infections of an unknown origin were detected in 81 patients (83.5% of the cases). The patients were randomized into 2 groups. The main group A included 42 patients who, along with casual therapy (33 of them were receiving only casual treatment), were receiving Polisorb MP in the clinical dose of 100-200 mg/kg of the body mass per day (average dosage — 2 grams, 4 times a day) as part of complex pathogenic therapy (detoxification and rehydration therapy, enzyme preparations, pre- and probiotics). The prescribed medicine intake period was 2 to 7 days (3-5 days on average). The control group B included 52 patients, medical treatment of whom included both casual (n = 43) and pathogenic therapies excluding enterosorbents.

Pathological foreign substances were detected in stools of patients of both groups at an identical rate (16% in group A and 17% in group B). 24 patients of the treatment group and 26 patients of the control group were assigned a parenteral detoxification/rehydration therapy with consideration to the specifics of disease progression. That notwithstanding, the average period of intravenous infusions was 2.4 days in patients of both groups. The period of assigned antibacterial therapy varied from 2 to 10 days with the average result in the treatment group being 4.8 days and in the control group — 5.2 days. The authors took notice of the rapid body temperature normalization in patients of the treatment group (33 patients presented with a burning fever). When the treatment included the use of Polisorb MP, the average number of days with fever was 1.7 days as opposed to 2.3 days for the patients of the control group (40 patients presented with a burning fever). The authors also stressed quicker subsidence of gastric indigestion and more rapid stool consistency normalization in group A patients (3.9 days with diarrhea) as opposed to the index value in group B patients – 4.1 days with diarrhea. Treatment group patients stayed in the hospital for 6.7 bed-days on average while the control group patients stayed for 7.7 bed-days on average. Notably, only 2 patients out of both groups had residual effects of the disease at the time of dismissal: one patient still had a loose stool (unauthorized leave from the medical ward) and one patient still had an insignificant amount of mucus in the stool.

A.S. Vershinin et al. (2008) investigated the efficiency of the use of Polisorb MP enterosorbent in children. The study included 65 children divided into 2 groups: Study group A – 35 children who were receiving Polisorb MP enterosorbent in conjunction with traditional background therapy (including specific antibacterial and antivirus therapies), and control group B – 30 children who were receiving traditional background therapy (including specific antibacterial and antivirus therapies). Children under one year old received the study medicine in the dosage 0.3-1g/day, 1-2 years – in the dosage 1-2 g/day, 2–7 years – 2–5 g/day, 7–14 years – 5–7 g/day, over 14 years – 7–20 g/day. Ages of the children are shown in Figure 1, and etiological structure of diseases on Figure 2 .

Figure 1 Ages of the children with AII who received traditional therapy with or without Polisorb MP 

Note: group A patients (n = 35) were receiving Polisorb MP enterosorbent together with the traditional therapy while group B patients (n = 30) did not receive this medicine.

Figure 2 Etiological structure of AII in children who received traditional therapy with or without Polisorb MP 

Note: group A patients (n = 35) were receiving Polisorb MP enterosorbent together with the traditional therapy while group B patients (n = 30) did not receive this medicine.

When using Polisorb MP enterosorbent for children the authors noted short intoxication symptom alleviation time, stool normalization and disappearance of pathological foreign substances as opposed to the control group patients’ indicator values. In connection with the assigned therapy, children of the study group showed better results of intestinal debridement from infectious agents (during a rotavirus infection). Therapeutic benefit of Polisorb MP was connected to a reduction of the duration of infectious disease, hospital stay and lower cost (as compared to analogous drugs) which allowed the authors to suggest possible positive economic effects. The researchers concluded that the enterosorption method using Polisorb MP can be recommended for treating intoxication syndrome and diarrhea in children.

L.I. Ratnikova et al. (2008) investigated the efficiency of enterosorbents. The study included 88 patients with bacterial food poisoning and salmonellosis (40 females and 48 males, aged between 17 and 70 years). Depending on the treatment method, the patients were divided into 4 groups: in group I (n = 50) patients received Polisorb MP as an enterosorbent in the dosage of 9g/day; in group II (n = 14) patients received activated carbon in the dosage of 6g/day; patients of group III (n = 13) were administered Filtrum medicine in the dosage of 3.2 g/day; patients of group IV (n = 11) were not administered enterosorbents. All patients received a rehydration therapy (both infusional and oral) and polyenzymes.

Treatment efficiency was assessed by the speed of subsidence of the main disease symptoms (fever, diarrhea, vomiting). Patients of group I were prescribed 3 grams of Polisorb MP 3 times per day on the day of their admission to hospital, treatment duration was 2 to 5 days depending on the duration of diarrhea and constituted 3.78 days on average. The duration of diarrhea syndrome was 3.58 days (1 to 7 days). The duration of the fever period was 1 to 6 days and constituted 2.09 days on average. Vomiting stopped on the day of hospital admission in all cases. The average hospitalization period equaled to 6.04 days. Patients of group II received 6 grams of activated carbon as an enterosorbent per day. The duration of diarrhea in patients of group II ranged from 1 to 5 days and constituted 3.85 days on average. The duration of the fever period was 1 to 4 days and constituted 2.2 days on average. The average hospitalization period for the patients of this group equaled to 6.25 days. The patients of group III received 0.8 grams of Filtrum medicine as an enterosorbent 4 times per day for 4-5 days. The treatment was assigned upon admission to hospital (day 1-3 of the disease). The duration of diarrhea for these patients was 4.6 days, duration of the fever period – 3.5 days and average bed-days – 8.33 days. The patients of group IV (11 total: 4 females and 7 males, aged between 25 and 58 years) did not receive enterosorbents and constituted the control group. The duration of diarrhea syndrome for the patients of this group was 1 to 7 days (3.98 days on average). The duration of the fever period was 2.5 days (2 to 3 days, and in two cases no temperature rise was detected) and average hospitalization period equaled to 6.9 days (3 to 13 days).

The authors reached the conclusion that enterosorption is an efficient and necessary method of treating intestinal disturbances. Inclusion of Polisorb MP in the treatment regimen allowed for a significant reduction in the duration of fever and diarrhea as compared to the patients of the control group. Patients that received Polisorb MP recovered earlier than those who received activated carbon. Prescribing Polisorb MP allowed for a significant reduction in the duration of fever, vomiting and diarrhea while hospitalized when compared to the patients of group III. Throughout the course of this study, Filtrum medicine did not affect the infection process.

N.V. Smirnova (2007) investigated the efficiency of Polisorb MP enterosorbent in patients with infectious diseases. The study included 42 patients, aged between 18 and 55 years, diagnosed with bacterial food poisoning. The patients were divided into 3 groups: patients of the first group in addition to the standard therapy were receiving 2 grams of Polisorb MP 4 times per day, an hour before a meal for 3 days since the first day of the disease; patients of the second group were receiving standard therapy without enterosorbents and patients of the third group were receiving 2 grams of Polisorb MP 5 times per day for 3 days as part of a monotherapy regimen. Clinical efficiency of the treatment was assessed by the duration of intoxication syndrome (fatigue, headache, loss of appetite), times of temperature normalization and subsidence of diarrhea. The duration of intoxication syndrome for patients receiving Polisorb MP together with the standard therapy was 1.5± 0.6 days, their temperature normalized in 1.3± 0.5 days and stool in 1.8± 0.7 days; for Patients that did not receive Polisorb MP, the figures were 1.8± 1.5, 1.7± 0.8 and 2.3± 0.3 days respectively, and for the patients of the third group – 1.5± 0.9, 1.4± 0.3 and 1.7± 0.5 days respectively, i.e. there was no significant difference from the first group patients.

L.I. Ratnikova et al. (2011) presented an experience of using Polisorb MP in the treatment of botulism. A 45 year old patient was admitted to the infection ward on the third day of the disease with complaints of muscle fatigue, nausea, vomiting, liquid stool, visual acuity decrement, blurry vision, double vision and choking when swallowing solid food. Past history has shown that the disease started acutely, 3-4 hours after ingesting 250 ml of pickled mushrooms (of the suillus variety) that she purchased from another individual. The patient felt cold, fatigue and abdominal pain. In the following hours multiple cases of vomiting (more than 20 times in 2 days of the disease), liquid stool 6-7 times per day were added to the number of symptoms. From the first hours of the disease the patient was ingesting Polisorb MP in large doses (25 g of the medicine in 2 days) without prescription. On the second day of the disease, muscle fatigue increased, vision impairments and difficulties when swallowing solid food manifested. On the third day of the disease the patient was brought to the infection ward by an ambulance unit. Her condition upon admission was qualified as moderate. Body temperature 37.3°C, ABP – 140/90 mm HG, heart rate – 80 beats/min. and respiratory rate – 22 per minute. The neurological status revealed mydriasis, limitation of eyeball movements, weakening of accommodation, impaired convergence and choking when swallowing fluid. Clinical and epidemiological diagnosis was: “moderate botulism”.

The premorbid background in the observed case was aggravated by the consequences of multiple surgical interventions on the abdominal organs (9 abdominal operations over the past 8 years, including surgery on the esophagus). The patient was admitted to the intensive care unit, where specific therapy with anti-botulinum serum was carried out intravenously and nonspecific detoxification was performed: gastric and intestinal lavage, Polisorb MP at a dose of 9 g / day, infusion therapy with crystalloid solutions and antibacterial therapy (ciprofloxacin per os). Previous surgeries on the esophagus caused technical difficulties in conducting the probe gastric lavage. The administered therapy restored swallowing ability and removed diplopia within a day. On the third day of hospitalization, the patient retained only residual symptoms of bulbar and ophthalmoplegic syndrome. However, at the same time the patient developed laboratory signs of pyelonephritis in the form of leukocyturia of up to 50 cells in the field of vision and an increase in the level of urea and creatinine in the blood by 1.5 times (from the upper limit of the norm), which was qualified as a nonspecific complication of botulism. In the following days, a positive trend was observed. The patient was discharged on the 16th day of the disease in satisfactory condition. Blood analysis using the neutralization test did not give results, probably due to late hospitalization.

When analyzing this clinical case, the authors emphasized the relative ease of the course of the disease after a short incubation. The onset of the disease with pronounced gastroenteritis, apparently, contributed to the mechanical removal of some of the toxins from the gastrointestinal tract. The early use of the Polisorb MP enterosorbent in large doses at the pre-hospital stage also provided a detoxification effect and could affect the benign nature of the course of the disease.

A.A. Pentyuk et al. (2008) investigated the efficiency of enterosorption of Polisorb. The study included 125 patients with acute gastroenterocolitis of various etiology and severity. Results of treatment were compared between 3 groups of patients. The first group (control) consisted of 55 patients treated with traditional methods. The second group consisted of 16 patients who took white clay (comparison medicine) in addition to traditional treatment. The third group (54 people) consisted of patients who received Polisorb MP in addition to traditional treatment. All patients received antibacterial drugs in usual doses (furasolidone — 0.1 g 4 times per day; phtalazolum — 1.0 g 4 times per day; chloramphenicol — 0.5 g 4 times per day) for an average of 3-7 days. Oral rehydration was performed. With severe dehydration, fluids were administered intravenously. Gastric lavage was performed for part of the patients (9–11%) upon admission. During the entire period of treatment, patients received calcium gluconate and multivitamins. Patients from the second group, in addition to the above drugs, received white clay at a dose of 20 g 4 times per day from the day of admission. Patients of the third group were prescribed Polisorb MP at a dose of 100 mg/kg divided into 3 doses per day. The sorbent was used in the form of an aqueous suspension for no more than 3 days. Considering the severity and nosological form of intestinal infection, additional subgroups were identified in each of the groups. The diagnosis was made on the basis of bacteriological examination, clinical picture, co-program data, indirect hemagglutination reaction with the corresponding diagnosis and epidemic history. Patients, in whom the pathogen was not isolated, made up a subgroup with a diagnosis of acute gastroenterocolitis of unknown etiology with a mild or moderate course respectively. The rest had opportunistic pathogenic microflora, shigellas and salmonellas. Therapy efficiency was assessed by the rate of regression of disease symptoms.

The authors have established a high efficiency of the inclusion of Polisorb MP in the complex of treatment of patients with AEI, which manifested itself in a significant acceleration of the regression of clinical and laboratory symptoms of the disease. The inclusion of white clay in the complex of treatment of patients did not have a significant additional therapeutic effect compared to the control. On the contrary, the use of Polisorb MP as a sorbent accelerated the relief of diarrhea syndrome, in comparison with traditional therapy and treatment with white clay (for example, in patients with a mild course of undifferentiated gastroenterocolitis by 2.9 and 2.6 times, respectively), and increased the positive dynamics of other symptoms of the disease. (nausea, vomiting, intestinal pain and spasm and loss of appetite). Co-program indicators normalized significantly faster. None of the 125 patients had a bacterial carriage or chronicity of the disease. Opportunistic pathogens were isolated during the repeated examination in two of the control patients who had salmonellosis (3.6%).

Vrach (The Doctor) No. 9, 2007, pp. 50-51

Smolensk State Medical Academy

Children’s Infectious Diseases Unit

Polisorb JSC

Grekova A.I., Smolyankin N.N., Vershinin A.S., Popilov A.N.

     Acute intestinal infections (AII) occupy one of the leading positions in infectious morbidity. 60-65% of all AII cases are registered among children, with a particularly high incidence in young children (up to 70%).

    According to recent literature, the entire spectrum of modern research allows us to determine the etiology of AII in 56-80% of cases. Such etiological agents as Salmonella, Shigella, Vibrio cholerae cause less than 10% of all cases of intestinal infections in children in developed countries.

     The share of rotavirus infection in the structure of AII varies from 9 to 73%, and is diagnosed in 20-60% of all children hospitalized for intestinal disorders.

      Changes in the etiological structure and pathogenesis of acute intestinal infections (AII) in children (an increase of viral diarrhea cases), an increase in bacterial resistance to antibacterial drugs and an increase in the number of adverse outcomes associated with a burdened premorbid background of patients in recent years all dictates the need to search for new etiopathogenetic drugs and improvement of therapy for patients with acute intestinal infections.

       The main direction of pathogenetic therapy of acute intestinal infectious diseases accompanied by diarrhea syndrome are as follows:

— detoxification

— fluid and electrolyte disorders correction

— correction of motor and secretory disorders of the gastrointestinal tract

— intestinal microflora disorders correction

— strengthening of reparative processes in the mucous membrane of large intestine

— enterosorption

Enterosorption in infectious diseases is not simply a pathogenetic method of therapy, but also is an etiological one, as sorbents are able to absorb not only endo- and exotoxins of pathogens, but also bind on its surface bacterial and viral agents, thus excluding them from the pathological process. The ability of enterosorbents to bind endo- and exotoxins of pathogens provides a significant contribution to macroorganism detoxification.

        On the Russian pharmaceutical market, various groups of enterosorbents are represented by activated charcoal, lignins, ion-exchange resins, which have quite different clinical effects, sometimes unpleasant organoleptic properties (polyphepan), different solubility status, the presence of various aromatic flavorings, which is vital when used in children with allergic pathology and, naturally and a possible traumatic effect on the mucous membrane of intestine.  In this regard, the production of new medications — enterosorbents which meets modern requirements, especially when used in children, remains vital.

     One of these new drugs is the domestically produced medication Polisorb MP, manufactured in Chelyabinsk by Polisorb JSC, which is made from fine silica and meets all the essential requirements for enterosorbents: is non-toxic, non-harmful for the mucous membrane of the gastrointestinal tract, is easily excreted from the gastrointestinal tract and is characterized by good sorption and organoleptic properties.     

      This work presents the results of the use of the enterosorbent «Polisorb-MP» in children with acute intestinal infections.

Purpose: 

Evaluation of the clinical efficacy of the medication-enterosorbent «Polisorb-MP», improvement of the pathogenetic therapy of acute intestinal infections in children accompanied by diarrhea syndrome.

Materials and methods:

In accordance with the purpose of work in 2005-2006, 65 children who were examined and hospitalized due to intestinal disorders at the MPTF Smolensk City Clinical Hospital No. 1​, department No. 5 (of intestinal infections) were examined. Clinical information on the phenomena of intoxication was used to evaluate the efficacy of the medication: duration of nausea, vomiting, decreased appetite; status of clinical signs of the disease: febrile period, abdominal syndrome, duration of diarrhea, the presence of pathological admixtures in feces; laboratory evaluation of the release of pathogens — bacteriological and serological methods were used.

     Children were divided into two groups. In the study group «A», 35 children received, along with conventional therapy (including specific antibacterial or antiviral), the medication/enterosorbent «Polisorb-MP», while in the control group «B», 30 children received the conventional therapy alone (including specific antibacterial or antiviral).

Children’s age structure

(SLIDE No. 1)

Children under the age of 5 years were predominant in both groups.

Etiological structure

(SLIDE No. 2)

The predominance of rotavirus infection was reported in both groups, as rotavirus infection was found in 18 children (51.4%) in the study group “A” and in 13 children in the control group “B” (43.3%).

According to the severity

(SLIDE No. 3)

The predominance of moderate forms in both groups was reported.

Evaluation of intoxication:

(SLIDE No.4)

The disappearance of symptoms of intoxication in the study group was completely reported on the 4th day with maximum extinction on the 1st and 2nd day, however in the control group the symptoms of intoxication persisted until the 7th day with maximum extinction on the 2nd and 4th day. 

Course of abdominal syndrome:

(SLIDE No. 5)

Abdominal syndrome was reversed in the study group predominantly by the 3rd day and persisted in 25% of the subjects until the 4th day in the control group.

Course of bowel movement:

(SLIDE No.6)

By the 3rd day, the stool was no longer loose in the overwhelming majority of the study group, while in the control group, 3.3% cases remained liquid until the 8th day of illness.

Pathological admixtures disappeared by the end of the second to third day in the study group while in the control group, they persisted up to the fifth day. 

An analysis of the obtained data the following course was reported:

COURSE OF CLINICAL SYMPTOMS OF THE DISEASE

CRITERIA	GROUPS
	GROUP “A”   (N-35)	GROUP “B”  (N-30)
Duration of fever	2.8 days	3.2 days
Duration of nausea and vomiting	2.3 days	3.6 days
Duration of abdominal pains	2.5 days	3.8 days
Duration of diarrhea	3.2 days	4.3 days
Preservation of pathological admixtures in feces (invasive diarrhea)	3.14 days	3.8 days
Average period of hospitalization	4.3 days	5.8 days

According to laboratory findings:

Pathogen	Group “A”		Group “B”
	Release of pathogen before the treatment	Release of pathogen after the treatment	Release of pathogen before the treatment	Release of pathogen after the treatment
Shigella Flexneri 2а	2	0	2	0
Rotavirus	18	0	13	5
Pathogen was not identified	15		15

COURSE OF LABORATORY FINDINGS

Out of 2 cases of shigellosis (Shigella Flexneri 2a was isolated) in group «A», a negative result was obtained in the control stool cultures after the therapy.

Rotavirus was not found in control studies of feces out of 18 cases of rotavirus infection (laboratory confirmed).

Out of 2 cases of shigellosis in the group «B», Shigella Flexneri 2a was isolated, a negative result was obtained in the control cultures after the therapy.

Of the 13 laboratory confirmed cases of rotavirus infection, in 5 cases rotaviruses was detected in the feces.

15 children were diagnosed with acute intestinal infection in both groups. 

The development of adverse reactions and manifestations of hypersensitivity to the used enterosorbent in sick children were not found. 

Conclusion:

Therefore, the obtained data indicate that:

1. Usage of the enterosorbent POLISORB-MP in children with acute intestinal infections, promotes a rapid reversal of intoxication symptoms, faster recovery of bowel movement and the disappearance of pathological admixtures when compared to the control group.

1. In the course of the conducted therapy, the best intestinal sanitation from infectious agents (with rotavirus infection) was achieved in the study group.

1. The therapeutic effect of the medication POLISORB with a reduction of infectious disease duration, hospitalization period and a lower cost (compared to analogs) suggests a possible economic benefit.

1. The enterosorption method with the use of the medication «Polisorb-MP» can be recommended for the treatment of acute intestinal infections in children with toxidrome and diarrhea syndrome. 

References:

1. «Enterosorbent Polisorb MP methodological recommendations for clinical use» Polisorb JSC, Chelyabinsk, 2006.

2. “Contemporary View on the Issue of Enterosorption. The Best Approach to Drug Selection” Ursova N.I. Gorelov A.V. Russian Medical Journal No. 19, 2006

3. “Infectious toxicosis in children” Uchaikin V.F., Molochny V.P. Moscow, 2002

SLIDE 1

SLIDE 2

SLIDE 3

SLIDE 4

SLIDE 5

SLIDE 6

According to different authors the rate of mortality from acute generalized peritonitis is from 24.4% to 55% [4,5]. One of the main reasons for this is impaired motor-evacuation function of the large intestine [1,2] and as a consequence, the development of endogenous intoxication syndrome (EIS), which determines to a large extent the severity of the disease.

Therefore the clinician is faced by the necessity to conduct detoxification actions among the patients with acute generalized peritonitis as soon as possible.

Enterosorbtion conducted in early postoperative period can be one of such actions.

P.K. Zagniboroda (1994) using the models of obturated and strangulated intestinal obstruction of dogs showed high efficiency of intraoperative enterosorbtion using enterosorbent POLYSORB MP.

For evaluation of clinical efficacy of POLYSORB MP in intensive care we used the medicine on 11 patients with acute generalized peritonitis of different ethiology (acute intestinal obstruction — 4 patients, perforation of the hollow organ — 4 patients, penetrating ballistic wounds of abdomen — 3 patients). The condition of patients and wounded was estimated as grave and very grave.

Technology. Through polyfunctional probes set intraoperatively into initial sections of small gut, during first hours after the operation lavage and enterosorbtion were conducted. Electrolytic solution with addition of POLYSORB MP with dose of 300 mg/kg/day was used as lavage medium. Enterosorbtion was done fractionally 4 times per day. Solution made with rated dose of POLYSORB MP was administered with Janet’s syringe into the gut through the probe and then the probe was clamped with exposure time 40 minutes, and then at the time of active aspiration the gut contents were removed.

When using the medicine it was noticed that POLYSORB MP is easily suspended in indoor temperature water without flocculation, this gives the possibility to deliver it into sounds of any diameter.

At the ground of conducted enterosorbtion during 3-5 days of postoperation period was noticed the decrease of the level of intoxication markers (LII, leucocytosis, stab shift, the level of middle-molecular peptides). The efficiency of enterosorbtion was proved by decrease of the level of GOT, GPT, creatinine, urea nitrogen and bilirubin in blood serum. This fact proves that usage of the POLYSORB MP at the time of enterosorbtion improves detoxication function not only of digestive tract but also of the detoxication organs (liver, kidneys). It should be noted that detoxication function was improved due to the strengthening of the barrier function of intestinal tract, normalization of indestinal flora and decrease of bacterial translocation. The other remarkable fact is that the level of creatinine in blood serum lowered almost in two times among patients with intact nephatony in comparison with control group (without usage of POLYSORB MP), this fact allows to advertise this medicine among patients with acute and chronic kidney disease in interdialysis period and in some cases even avoid hemodialysis.

Therefore, enterosorbent POLYSORB MP (CJSC Polysorb, the city of Chelyabinsk) is high-efficiency medicine for complex therapy of difficult cases of generalized peritonitis that is accompanied by frank organ disorders.

References:

1.Belyakov N.A. and others. Intraoperative decompression and sorption dialysis of small intestine in case of peritonitis: Manual for medical practitioners. St. Petersburg, 1998.p.3.

2.Burnevich S.Z. and others. The condition of barrier function of digestive tract in case of generalized peritonitis// Endointoxications. Thesis of international symposium. St. Petersburg,1994.p.23.

3.Zagniboroda P.K. The efficiency of intraoperational enterosorbtion with usage of Polysorb in cases of acute intestinal obstruction. ib, p.219.

4. Popova Т. S. and others. Intestinal obstruction syndrome in surgery. Мoscow, 1991.

5. Shorokh G.P. and others. Complex approach to detoxication of organism in case of generalized peritonitis // Endointoxications. Thesis of international symposium. St. Petersburg,1994. P.58.

Under the Approval of Main Army-Medical Direction of Ministry of Defence of RF №161/7/1/1859 dated 07.04.2000г. in Hematological Center (HC) named after the acad. N.N. Burdenko from 10.04. 2000 to 05.05.2000 Clinical enterosorbent absorbation was carried out POLYSORB MP (CJSC Polysorb, Chelyabinsk).

In order to achieve the assigned objective this medicine was administrated in the organism of 77 patients. These patients are undergoing treatment in different units of HC named after N.N. Burdenko in the following groups:

1)        15 patients with coronary disease which were cardia bypass open-heart operated;

2)       42 patients with infectual diseases (acute enteric infection, virus hepatitis, yersinia infections, pseudotuberculosis);

3)       10 patientwithheroinintoxication.

For POLYSORB clinical effect appraisal different clinical tests besides clinical methods were carried out (leucocytosis, band changes, blood-sedimentation test, leucocytal intoxication quotient, medium molecules levels, glucose, creatinine, GOT, GPT, urea nitrogen, bilirubin in blood, urea and blood diastase).

Open-heart surgery usesfactors of considerable force and depth: cardia bypass, total body hypothermia, pharmaco hypothermic cardioplegia, anoxic myocardial ischemia. In post-operation period some patients had considerable changes in phlogistic response, and life support can be affected (heart-vascular system, GI tract, eliminative organs and detoxication), it leads to endotoxemia progression. Fifteen patients with coronary heart disease underwent myocardial revasculization surgery and used POLYSORB MP. There were twenty patients in the control group; these patients received a course of congestive heart failure operative therapy. Both groups were strictly randomized (randomization tests: coronary affection, pumping ability affection of left ventricle, age of patients, associated diseases, extent and character of operational intervention; exception criteria: perioperative acute myocardial infarction, severe acute cardiovascular collapse, profuse blood loss).

Technology. Enteral use of medicine was prescribed in the form of aquatic suspension after extubation in early postoperative period. Drug dose made 200 mg/kg/day, is used 3 times per day 2 hours after meals and other medicine use. Enterosorbent course takes 5 days.

POLYSORB MP has no taste and odor, that’s why tolerance is good.

Enterosorbent presentation of POLYSORB MP consists in:

1)       improvement of subjective general mend (1-2 day before than subjective results in control group);

2)       absence of dyspeptic disorder in post-operation period (in control group 5 patients felt sick and voimit);

3)       lower intensity of postpericardiac syndrome.

After laboratory findings analysis in both groups where patients used enterosorbent POLYSORB MP, vitalses normalization is earlier (4-5 days) than it is in control group (8-10 days): creatinine, urea nitrogen, glucose, blood serum diastase, medium molecules levels, intoxication leukocytic index. Four patients with diabetes mellitus of second stage showed positive results in enterosorbent use, consisting in carbohydrate metabolism subcompensation, the second day after post-operation period and during 5-8 days after post-operation period carbohydrate metabolism subcompensation was still evident in control group analyses.

Consequently, enterosorbent POLYSORB MP was used by patients who underwent bypass open-heart operation. This medicine is an active and harmless component in post-operation treatment, optimizes base treatment, considerably improves post-operation results. Patients quickly recover and leave surgical hospital (2 days before than patients of control group).

Acute infectious diseases. Forty-two patients with intermediate and severe forms of acute infectious diseases used POLYSORB MP. There are thirty-five patients in control group, these patients didn’t use enterosorbent.

Technology. After admission, medicine in the form of aquatic suspension is prescribed to take in orally. Daily dose makes 200 mg/kg/day. A patient with acute diarrheal syndrome takes in daily dose during 5 hours every hour. Further medicine is prescribed to be taken four times per day 1.5-2 hours after meals and after other medicine. Enterosorbent POLYSORB MP was used in combination with eubiotics, probiotics treatment (bifidumbacterin forte (Probifor), Flonivin, Bactisubtil, Normoflor).

Twenty patients with acute enteric infection (salmonellosis, shigellosis, colibacillosis, bacterial food poisoning) shown the following results:

1)      diarrheal syndrome period decreased for 2 days (in control group 4-5 days);

2)      there was no meteorism the second day after enterosorbent was taken in. But 40 % of patients had symptoms of meteorism during 7 days of base therapy after admission;

3)      general intoxication syndrome decreased for 1-2 days with POLYSORB MP use (for 4-5 days in control group);

4)      there was no anorexia the first day after POLYSORB MP use (in control group 50 % patients suffered from loss of appetite during treatment of 6-7 days).

Enterosorbent POLYSORB MP use quickly reduced endointoxication and anorexia syndrome in the organism of 15 patients with virus hepatitis А and В (clinical overt forms of severe and intermediate forms). In the period of fast recovery 7 patients with Yersinia syndrome and pseudotuberculosis deceases shown fast antibiotic colitis resolution caused by dysbacteriosis.

Therefore POLYSORB MP is high-effective enterosorbent used in acute infectious disease complex therapy.

POLYSORB MP was used to treat 10 patients with heroin intoxication in order to prepare them for pharmacologic detoxication. Fourteen patients with heroin intoxication formed the control group, they didn’t take in enterosorbent.

Technology. Probe with aquatic suspension was administrated in stomach during the period when the patient was under anaesthesia and after intubation of trachea and APV. Daily dose of POLYSORB MP was administrated each 2,5 hours. After pharmacological detoxication under anaesthesia the probe was pulled out with active aspiration of gastric contents. Patients which used POLYSORB MP showed the following results:

1)      there is no dyspeptic disorder (sickness, vomiting, loose stool);

2)      negative tests in 100 %, there are no opioids in urine after pharmacological detoxication under anaesthesia (in control group these tests were positive in 30 %). GI tract absorbs and eliminates a portion of heroin. 

 Acute enteric infections (AEI) take one of the leading places in the range of infectious incidences. 60 — 65% of all the AEI cases are registered among children, at that the incidence rate among young children is particularly high (up to 70%).

  According to literature sources, the whole complex of modern researches helps to define AEI etiology in 56—80% of cases. Such aetiologic agents as Salmonella, Shigella, Vibrio cholerae cause less than 10% of all the intestinal infections cases of children in civilized countries

  The rate of rotavirus infections in the structure of AEI varies from 9 to 73%, and in respect of all the children, hospitalized on the occasion of enteric disorders, it makes 20—60%.

  Change of aetiologic structure and pathogenesis of AEI of children (increase of the number of virus diarrhea), resistance increase of bacteria to antimicrobials, increase of the number of unfavorable outcomes in recent years, connected with burdened preclinical background of patients, dictate terms of search for new etiopathogenesis medicines and development of therapy for patients with acute enteric infections.

  Basic directions of pathogenetic therapy for the treatment of acute enteric infectious diseases accompanied by diarrhea syndrome, are as follows:

deintoxication;

aquatic-electrolytic disorder correction;

motor-secretory disorder correction of gastro-intestinal tract;

correction of gut organisms disorders;

reinforcement of reparative processes in mucous membrane of large bowel;

enterosorption.

   Enterosorption in case of infectious diseases is not just pathogenetic therapy method, but also aetiologic, as sorbing agents can uptake not just endo- and ectotoxind of causative agents, but also detect at its surface causative agents of bacterial and viral nature, thus excluding them from pathologic process. The ability of enterosorbents to bind endo- and ectotoxins of causative agents contributes much to the macroorganism deintoxication.

  At the pharmaceutical market of Russia various groups of enterosorbents are presented by absorbent carbons, lignines, ion exchanger resins, which have quite different clinical effect, sometimes unpleasant organoleptical properties (Polyphepan), different level of solubility, various aromatic flavorings, which are vital in case of children treatment with allergic diseases and, of course, possible traumatic impact on mucous membrane of the intestinal tract. In this respect the problem of use of new medicine – enterosorbents, which meets modern requirements, especially in respect of children, is quite vital.

  One of new medicines is native drug POLYSORB MP, manufactured by Polysorb CJSC, city of Cheliabinsk, produced from fine silicon, meeting all basic requirements in respect of enterosorbents: non toxic, does not traumatize mucous membrane of gastro-intestinal tract, can be easily removed from gastro-intestinal tract, has good sorption and organoleptical properties.

  The results of using enterosorbent POLYSORB MP for the treatment of acute enteric infections of children were included into this work.

Purpose:

  Estimation of clinical efficiency of the medicine-enterosorbent POLYSORB MP, development of pathogenetic therapy of acute enteric infections of children, followed by diarrhea syndrome.

Materials and methods:

  In compliance with the work purpose in 2005-2006 65 children were examined, who underwent hospital treatment at MMPI (Municipal Medical and Preventive Treatment Institution) City Clinical hospital №1, City of Smolensk, department №5 (intestinal infections). Clinical information on intoxication phenomena estimation was used for the medicine efficiency estimation: duration of sickness, vomit, dysorexia; evidence of disease clinical features: feverish period, abdominal syndrome, diarrhea period, presence of abnormal foreign substances in the stool; laboratory evaluation of causative agent release –bacteriological and serologic methods were used.

  2 groups of children were selected, group “А” — 35 children apart from traditional basis therapy (including specific antimicrobial or antiviral) underwent the treatment with the help of the enterosorbent POLYSORB MP and control group “B” — 30 children who underwent the traditional basis (including specific antimicrobial or antiviral) therapy.

  Total absence of intoxication syndromes in the group examined stated at the 4^th day with maximum fading at the 1^st
and the 2^nd day, and in the control group – intoxication symptoms preserved to the 7^th day with maximum fading at the 2^nd and the 4^th.

  Abdominal syndrome cut shorted in the research group with the overwhelming majority up to the 3^rd day, in the control set in 25% preserved up to the 4^th day.

  In the research group with the overwhelming majority up to the 3^rd
day the stool was formed, in the control group in 3.3% it was preserved to be liquid to the 8^th day of disease.

  In the research group abnormal foreign substances disappeared up to the end of the 2-3^rd day, in the control group preserved up to 5 days.

 The following dynamics was formed in the process of obtained data analysis:

 DYNAMICSOFclinical symptoms

CRITERIA	GROUPS
	Group“А”  (N-35)	Group“B” (N-30)
Fever response duration	2.8 days	3.2 days
Duration of sickness and vomit	2.3 days	3.6 days
Durationof bellyache	2.5 days	3.8 days
Diarrhea duration	3.2 days	4.3 days
Preservation of abnormal foreign substances in stool (intrusive diarrhea)	3.14 days	3.8 days
Average period of hospitalization	4.3 days	5.8 days

According tolaboratory findings:

Causative agent	Group“А”		Group“B”
	Release of causative agents before treatment	Release of causative agents after treatment	Release of causative agents before treatment	Release of causative agents after treatment
Shigella Flexneri 2а	2	0	2	0
Rotavirus	18	0	13	5
Causative agents notreleased	15		15

laboratory findings dynamics

  In the group “А” out of 2 cases of shigellosis (released Shigella Flexneri 2а), in control inoculations of fecal masses after the therapy held only negative findings were detected.

  Out of 18 cases of rotavirus infection (laboratory certified) in the control studies of fecal masses the rotavirus was not detected.

  In the group “B” out of 2 cases of shigellosis Shigella Flexneri 2а was released, in control inoculations after therapy only negative findings were detected.

  Positive control inoculations of fecal masses for rotaviruses were detected in 5 out of 13 cases of rotavirus infection (laboratory certified).

  In both the groups 15 children were made a diagnosis of acute enteric infection, not certified laboratory.

  Development of adverse reactions and hyperresponsiveness to the enterosorbent used in the range of patients were not detected.

Conclusions:

Therefore, the information received shows that:

1. In the process of using enterosorbent POLYSORB MP by children with acute enteric infection there was determined quick intoxication syndrome reduction dynamics, stool normalization and disappearance of abnormal foreign substances in comparison with the control group.

2.  On the back of therapy held in the examined group, better intestinal tract sanitation from pathogenic causative agents (in case of rotavirus infection) was achieved.

3. Therapeutic action of POLYSORB with reduction of infectious disease duration, terms of hospitalization and lower cost of the medicine (in comparison with analogue) presupposes possible positive benefits.

4. Enterosorption method with the use of POLYSORB MP can be recommended for the treatment of children acute enteric infections with the syndrome of intoxication and diarrhea. 

  Endogenous intoxication based on bacteriotoxemia, increase in average mass molecules, andhemostasis abnormality accompanied by haemodynamics disorders predetermine the search of methods of artificial detoxification with high efficacy and minimal damaging action. One of the possible methods of detoxification is enterosorbents.

  This work includes the results of Polisorb MP therapy in children with acute enteric infections. Polisorb MP is a novel enterosorbent which is manufactured by ZAO Polisorb, Chelyabinsk.

  25 children aged from 2 months to 6 years were administered the drug and the majority of  the children (21) were infants. The diagnosis of acute enteric infection was made on the ground of clinical, epidemiological, and laboratory data. 

  Polisorb MP was administered at the moment of admission with dose 100 mg/kg/day. The children took the sorbent in the form of water mixture (50 ml) 4 times a day 1 hour before meal and drugs.

  The following results were obtained:

1. Stool came to normal after 2.5±1.1 days of the therapy and after 7.3±1.9 days in control group.

2. Signs of intoxication persisted for 1.7±0.2 days in patients who took Polisorb MP and for 7.1±1.3 days in patients who did not take the drug.

  Hence, available data suggest that Polysorb MP as a part of complex treatment is useful for acute enteric infections in children with treatment course of 3 – 5 days.  

  Acute enteric infections and viral hepatitides are still among the most common diseases with higher incidence only for acute respiratory infections. Containment efforts are associated with some difficulties due to inadequate efficacy or absence of etiotropic drugs. Antibiotics and chemotherapeutic agents are unsafe and should be administered only in case of severe shigellosis and generalized infection. However if only pathogenetic therapy is used there is a risk of chronic infection and bacteria carrying.

  The possible solution for the problem would be enterosorbents which would bind pathogenic agents, and toxic substances and have no negative properties of antibiotics. Sorbents are successfully used for diarrhea and viral hepatitis. However many of them show necessary therapeutic effect only when administered in high doses (up to 100 g/day) causing disorders of morphology and function of bowels.

  A novel enterosorbent Polisorb MP was developed on the basis of fine-grained silica. Due tio its hydrophilia, high sorption activity towards microbes, and affinity to some biologically active substances the drug is supposed to be efficient in the treatment for acute enteric infections and viral hepatitides.

  Our studies were aimed to evaluate action of Polisorb MP as a part of complex therapy for acute enteric infections and viral hepatitides and to specify contraindications and possible side-effects.

  The results of treatment of 125 patients with acute gastroenterocolitis of various etiology and degree of severity and 46 patients with viral hepatitis were analyzed. The results of treatment of patients with acute enteric infections were compared between three groups. The first (control) group included 55 patients who were treated with traditional methods. The second group included 16 patients who were treated with traditional methods and bolus alba (comparator drug). The third group included 54 patients who were treated with traditional methods and Polisorb MP.

  All the patients were administered standard-dose antibiotics (furazolidone 0.1 g 4 times a day; phthalazolum 1.0 g 4 times a day; laevomycetin 0.5 g 4 times a day) for the average of 3 – 7 days and oral rehydratation (Phillips solution number 1, rehydron, 5 % glucose solution). If a patient experienced marked dehydratation, he/she was administered intravenous therapy. Some patients (9 – 11 %) were made gastric lavage. During the treatment the patients took calcium gluconate and vitamins. The second group was also administered bolus alba 20 g 4 times a day and the third group – Polisorb MP 100 mg/kg 3 times a day. The sorbent was taken in the form of water suspension not more than 3 days.

  Every group was divided into subgroups according to degree of severity and clinical entity of enteric infection. The diagnosis was made on the basis of clinical presentation, epidemiological anamnesis, the results of bacteriological examination, coprogram, and indirect hemagglutination test with appropriate diagnosticum. Patients with unspecified causative agent were included in the subgroup with diagnosis: mild or moderate to severe acute gastroenterocolitis of unknown etiology. Opportunistic pathogens, Shigella and Salmonella were identified in other patients. Treatment efficacy was assessed by rate of signs regression.

  Polisorb MP 100 mg/kg 2 times a day was administered as a part of complex therapy for viral hepatitis. 21 patients took oral 3 % water suspension of sorbent for 7 days in average. 25 patients who were administered conventional therapy without enterosorbents were used as controls. The treatment depends on degree of severity of viral hepatitis. So the patients of these two groups were divided into three subgroups: 8 patients of the control group and 6 patients of the experimental group (1^st subgroup) were administered baseline therapy (diet, vitamins, and choleretics); 12 patients of control group and 11 patients who took Polisorb MP (2^nd subgroup) were additionally administered infusion solutions (5 % glucose solution, hemodez, and Phillips solution), antihistamines, and spasmolytics; 5 patients of control group and 4 patients of experimental group (3^d subgroup) were additionally administered prednisolone. Standardtreatmentsanddrugsdoseswereused.

  The diagnosis was made on the basis of clinical presentation and results of biochemical tests. The diagnosis was confirmed by identification of Australia antigen in 44 % of patients of control group and 42.9 % of patients who were administered the sorbent. Treatment efficacy was assessed by rate of evolution of clinical signs (jaundice, skin itching, color of urine and stool), serum bilirubin level, activity of aminotransferases and alkaline phosphatase.

  Groups were formed using random sampling technique, and they were not significantly varied in gender, age, and pre-morbid background. Frequency and intensity of signs before treatment was nearly equal in all compared subgroups. Average values were calculated using the data of patients who had analyzed feature.

  The studies revealed high efficacy of Polisorb MP as a part of complex therapy for acute enteric infections and viral hepatitis which was confirmed by significant regression of clinical and laboratory signs.

  Bolus alba as a part complex therapy for acute enteric infections does not have significant additional therapeutic effect comparing with control. However Polisorb MP stops diarrhea faster than conventional therapy and bolus alba (for example, 2.9 and 2.6 times faster in patients with mild undifferentiated gastroenterocolitis respectively) and improve other signs (nausea, vomiting, colics, appetite loss). Coprogram was normalized significantly faster.

  Neither bacteria carrying nor chronic infection were identified in any of 125 patients. Opportunistic pathogens were found in two patients with history of salmonellosis (3.6 %) at re-examination.

  Slight stool retention (up to 2 days) before its normalization was observed in each group. Perhaps, this is a variant of normal course of recovery period. In the control group constipation developed in 4 patients (7.3 %) who were administered conventional therapy and in 2 patients (12.5 %) who were administered bolus alba. Stool retention over 2 days was not observed in patients who were administered Polisorb MP 100 mg/kg/day for 3 days.

Table 1. Evolution of clinical signs of salmonellosis during complex therapy using Polisorb MP (М±m)

Signs duration (h)	Conventional therapy	Complex therapy using Polisorb MP
Salmonellosis
Nausea	61.7±14.5	40.0±4.2
Vomiting	38.0±14.9	20.0±2.1
Diarrhea	133.7+7.3	47.7±10.9*
Appetite loss	78.9±14.5	54.9±7.3
Abdominal pains	72.0±7.3	51.4±7.3
Enterospasm	136.0±29.7	60.0±6.7
Normalization of coprogram values	133.7±25.4	62.0±8.5*

Table 2. Evolution of clinical signs of dysentery during complex therapy using Polisorb MP (М±m)

Signs duration (h)	Conventional therapy	Complex therapy using Polisorb MP
Dysentery
Nausea	54.0±6.7	54.0±6.7
Diarrhea	172.8±36.1	56.0±10.0*
Appetite loss	72.0±20.6	48.0±20.1
Abdominal pains	139.2±36.1	56.0±10.0
Enterospasm	206.4±41.2	72.0±20.1*
Normalization of coprogram values	168.0±36.1	96.0±30.1

  Polisorb MP as a part of complex therapy for viral hepatitis significantly accelerates the recovery: jaundice and skin itch disappear by 4 – 6 and 6 – 7 days earlier, and color of urine and stool improves faster. Blood values, serum bilirubin level and activity of aminotransferases (Table 3), normalizes in these patients earlier. Polisorb MP had no side-effects.

Table 3. Evolution of laboratory signs of liver damage during complex therapy using Polisorb MP (М±m)

Values	Subgroup	Conventional therapy		Conventional therapy + Polisorb MP
		Before treatment	7-10 days after	Before treatment	7-10 days after
Bilirubin (mmol/l)	1	130±7.4	66.4±5.4*	122±9.7	46.4±4.9*
	2	160±9.6	108±8.2*	174±11.8	82.8±14.3*
	3	264±9.7	192±15.9*	244±28.7	151±22.8*
Alanine aminotransferase (mmol/l *h)	1	2.8±0.93	1.9±0.31*	3.1±0.41	1.4±0.25*
	2	2.9±0.35	2.1±0.22*	2.8±0.29	1.5±0.17*
	3	3.2±0.65	2.2±0.19	3.0±0.73	1.5±0.28
Alkaline phosphatase (U/l).	1	—	—	—	—
	2	190±19.2	134±9.8	174±11.8	112±4.2*
	3	207±24.3	162±13.5	181±31.4	133±16.8

Note: significance of difference is showed between groups “before treatment” and “10 days after”

  Comparison of the results of the Polisorb MP therapy with available literature data on therapeutic activity of other sorbents show that antidiarrheal action of Polisorb MP exceeds comparator sorbents and its therapeutic effect in patients with viral hepatitides is not inferior to modern coal sorbents and lignin derivates.

Method of administration of Polisorb MP:

  Our experience indicates that Polisorb MP is better to be administered in the form of water suspension. To prepare the suspension the appropriate amount of drug is adjusted with boiled water to mark 250 ml. The drug is administered at daily dose of 100 mg/kg 2 – 3 times a day. Patients with acute enteric infections are recommended to take the drug as early as possible. The first dose can be increased to 5 g (100 ml of water suspension). If a patient has vomiting the drug is given through gastric tube. 2-day therapy of Polisorb MP is sufficient in most of the cases of acute enteric infections. 5-7-day therapy of Polisorb MP (6 – 9 g per day) significantly improves the state of patient with viral hepatitis and shortens the duration of hospital stay.

  A separate study is devoted to the investigation of Polisorb MP efficacy in 144 children with severe enteric toxicosis who stayed in the Intensive Care Department of Khmelnitsk Infectious Diseases Hospital. The results of clinical observation and laboratory tests (P-proteins, immune complexes, erythrocyte index of endogenous intoxication, average mass molecules, malonic dialdehyde, diene conjugates, and dieneketones) showed high therapeutic activity of Polisorb MP 150 -200 mg/kg/day 3 – 4 times a day as a part of complex therapy for enteric toxicosis in children. For example, diarrhea stopped more than 2 days earlier comparing with the control group (children who were not administered Polisorb MP). Neurotoxicosis, microcirculation disorders, etc. resolved significantly faster, and laboratory values were normalized 1.5 – 2 times quicker. If the patients had vomiting they were given enemas with Polisorb MP. When vomiting stopped the patients were transferred to oral therapy. The duration of enterosorption depended on child’s state and averaged 2 – 3 days for moderate to severe toxicosis and 3 – 4 days for severe toxicosis. Polisorb MP did not cause any side-effects or complications.

Conclusions:

1. Polisorb MP as a part of complex therapy for acute enteric infections and viral hepatitis has a marked therapeutic effect.
2. Polisorb MP did not promote chronic infection and bacteria carrying.