THE ROLE OF POLISORB MP IN THE TREATMENT FOR ACUTE ENTERIC INFECTIONS AND VIRAL HEPATITIS

  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 (1st subgroup) were administered baseline therapy (diet, vitamins, and choleretics); 12 patients of control group and 11 patients who took Polisorb MP (2nd 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 (3d 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.