Research report (стр. 8 )

CONCLUSION

The study of efficacy and safety of using the drug Enterosgel ®, indicated for the treatment of patients with irritable bowel syndrome with predominant diarrhea demonstrated the effectiveness of the study drug.

When evaluating complaints of patients with IBS with diarrhea was found that the rate of drug administration Enterosgel ® has reduced the incidence of abdominal pain, rumbling in the abdomen, excessive flatus, unpleasant taste in the mouth. A statistical comparison of clinical efficacy of the study drug _ drug comparisons showed no statistically significant differences between the groups (p> 0,05): in both groups equally decreased the incidence of abdominal pain, rumbling in the abdomen, excessive flatus, unpleasant taste mouth. The frequency of the propensity to looser stools in the study group decreased from 93.3% to 46.7%, while in the control group it increased from 46.7% to 80.0%.

When evaluating data of the questionnaire GSRS in patients receiving study drug showed a significant decrease of severity of complaints on the scales of abdominal pain, diarrhea syndrome, dyspeptic syndrome, _ on the scale of the total measurement.

An important effect should also recognize the significant reduction of subjective sensations of pain, which is celebrated on patients after treatment medication Enterosgel ®.

Evaluation of stool frequency in patients with IBS with diarrhea allowed to reveal the beneficial effects of the course of a study drug: reduction in stool frequency (full normalization of stool frequency was observed in almost Ѕ of patients) _ improvement in stool (complete normalization of stools was observed in 2/3 patients ).

According to the coprogram, after a course of therapy with Enterosgel ® was observed the normalization of stool consistency, normalization of digestion of vegetable fiber and protein components of food. Thus, after a course of therapy study medication Enterosgel ® patients there was a significant _ substantial reduction in symptoms of IBS as the results of the subjective assessment of the patient (according to the complaint standardized questionnaire and questionnaire data GSRS, pain intensity VAS) and objective manifestations of the disease (stool frequency _ stool form scale on Bristol). The most clinically significant changes were observed in patients of the main group were: normalization of stool frequency (slowing of up to 7 times a week), normalization of stool form (up to 4 types of stool on the Bristol scale) and a decrease in severity of pain. In contrast to the reference drug (bismuth tri dicitratobismuthate), in the treatment of patients medication Enterosgel ® noted a beneficial effect not only on subjective clinical manifestations of IBS, but also normalization of stool frequency and form, improve digestion according coprogram. After the course of taking of the enterosobrent Enterosgel ® was not observed negative changes in the quantitative composition of the intestinal microflora, in contrast, there was found clinically not significant increase in the number of bifidobacteria and clinically significant reduction in the number of enterotoxigenic Escherichia coli (before therapy increase its amount was observed in 80% of patients after a course of therapy - only 50%). When analyzing the data of the quality of life questionnaire SF-36 and  psychological questionnaires _after a course of Enterosgel was not a statistically significant change in the quality of life on all scales of quality of life, reactive anxiety, trait anxiety_ fatigue.

Enterosgel ® drug had no effect on clinical and biochemical parameters of blood, kidney function. Course of taking the drug did not cause clinically significant decrease in absorption of trace elements and vitamins in the gastrointestinal tract, which could result in a decrease in their concentration in the blood. The study drug also had no effect on the function of digestion on the results coprogram.

Interesting facts revealed in the course of examination of patients with diarrheal predominant form of IBS, is observed both before and after treatment with aberrant reaction IEA postprandial period. Prior to treatment in 11 patients (37%) out of 30 patients with IBS-D AUC exceeded 1.5, reaching in 8 (27%) patients values​​> 2.0; while 12 (40%) patients had a decrease of AUC <1.0, reaching in 7 (23%) patients values ​​of <0.6. After treatment in 16 (53%) patients showed a reduction in AUC <1.0, increased the AUC> 1.5 was observed in 8 (27%) patients, of whom 5 (17%) AUC was> 2.0. It is possible that after treatment, against clinical improvement, reduction of diarrhea and the evacuation function normalization trend towards significant decrease AUC and decrease postprandial power is expected. Further study of the IEA in patients with different forms of IBS is reasonable for the selection and correction of adequate therapy for this category of patients. Studies on a large number of patients may allow to develop an algorithm of treatment of patients with IBS-D, based on study of the IEA of digestive tract.

Another interesting fact from the examination of patients with IBS with diarrhea is that after a course of therapy with Enterosgel ® in patients of the main group showed a tendency to decrease in serotonin levels in the blood.

CONCLUSIONS

-  Enterosgel ® has a positive effect on the clinical picture of the disease, reduces the severity of abdominal pain, normalize stool frequency in patients with IBS with diarrhea contributes to the harmonization of quality of life.

- Due to the treatment by Enterosgel ® in patients with IBS with diarrhea, a decrease signs of dysbiosis of the digestive tract are seen, together with improvement of the quantitative and qualitative composition of the microflora of the colon.

- Enterosgel ® is well tolerated, safe, can be recommended for use in patients with IBS with diarrhea.

- Treatment regimens that can be recommended for use in patients with IBS with diarrhea: orally for 3 consecutive weeks at a dose of 1 g of paste 22.5 with the active substance polymethylsiloxane polyhydrate 3 times a day 1 hour after a meal (pasta dose divorces 200 ml of cool boiled water or washed down with at least 200 ml of cool boiled water).

Principal researcher,

Head of Department

propedeutics of Internal Medicine

SZGMU. II Mechnikov

Z. d.n. RF, MD, Professor H. Tkachenko

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