[Endoscopic and morphometric analysis of the reduction of acute inflammatory process in the gastric mucosa after therapy with Regasthym Gastro].

AIM: To analyze the anti-inflammatory efficacy of Regasthym Gastro (alpha-glutamyl-tryptophan) in the treatment of patients with chronic atrophic gastritis according to endoscopic and morphometric studies. MATERIALS AND METHODS: As part of a double-blind placebo-controlled study, the results of gastroscopy and histological (morphometric) studies were retrospective analyzed in 80 patients diagnosed with chronic atrophic gastritis associated with Helicobacter pylori in exacerbation: 43 patients took Regasthym Gastro, 37 patients - placebo. The conclusions of the gastroscopy were structured in the form of a standardized scale, which included an assessment of criteria in points (from 0 to 3): thickness of folds, hyperemia, edema of the gastric mucosa, the signs of atrophy, metaplasia; the severity of the erosive process. The sum of points according to all criteria was used to assess the dynamics of the inflammatory process: positive dynamics; lack of dynamics; the pathological process is progressing. The results of the endoscopic examination were compared with morphometry data (the number of inflammation pool cells per 1 mm2 of gastric mucosa). Statistical processing of the results was carried out using the Statistica 12 application software package. RESULTS: According to the gastroscopy, before therapy, hyperemia of the gastric mucosa was present in 82.5%, edema - in 53.8%, erosion - in 17.5%, signs of metaplasia - in 12.5% of patients. After therapy with the investigated drug a statistically significant decrease in the severity of edema of the gastric mucosa (p=0.008), the total set of signs of acute inflammatory process (p=0.006), a decrease in the proportion of outcomes with negative dynamics of the inflammatory process (p=0.038) was revealed. Statistically significant (p<0.05) correlations were found between gastroscopy data of inflammation and the number of neutrophil, eosinophil granulocytes, macrophages and lymphocytes per 1 mm2. CONCLUSION: Regasthym Gastro contributes to a significant decrease in the severity of the inflammatory process according to the evaluation of the results of gastroscopy and morphometry. It is possible to recommend the inclusion of this drug in the complex therapy of chronic gastritis to increase the effectiveness and reduce the risks of progression of inflammation.

[The results of phase III multicenter open randomized controlled study REM-Chol-III-16 in patients with intrahepatic cholestasis syndrome caused by chronic diffuse liver diseases].

AIM: To assess the safety and efficacy of Remaxol, solution for infusion, compared with parenteral form of S-adenosyl-L-methionine, in the treatment of patients with intrahepatic cholestasis syndrome accompanying chronic diffuse liver diseases of various etiology. MATERIALS AND METHODS: In a multicenter open-label comparative study of the safety and efficacy of Remaxol (inosine + meglumine + methionine + nicotinamide + succinic acid) 317 patients aged 18 to 65 years were randomized into 2 groups: patients of the experimental group (n=168) received intravenous Remaxol, solution for infusion, 400 ml, and patients of the control group (n=149) Heptral (S-adenosyl-L-methionine) 800 mg. The duration of treatment was 10 days. The primary efficacy endpoint was the proportion of patients who responded to therapy, as demonstrated by dynamics of laboratory parameters of liver functional status: decrease in gamma glutamyl transpeptidase level by 40%, and/or alkaline phosphatase level by 30%, and/or decrease total bilirubin level by 30% from baseline by the end of the treatment course. RESULTS: The proportion of responders was 51% in the Remaxol group vs. 44.9% in the Heptral group (p=0.303); the lower limit of the one-sided 95% confidence interval for the difference in the proportions of responders was -4.01%, which exceeds the non-inferiority margin pre-defined by the study protocol, thus, the non-inferiority hypothesis was proven, i.e. Remaxol at a dose of 400 ml/day demonstrates similar efficacy to Heptral at a dose of 800 mg/day in patients with intrahepatic cholestasis syndrome associated with chronic diffuse liver diseases. Similar positive trends in the levels of transaminases, total bilirubin and the severity of pruritus were revealed in both treatment groups. We did not reveal statistically significant between-group differences in the frequency of adverse events definitely related to the study treatment. CONCLUSION: Administration of Remaxol as a part of the pathogenetic therapy of patients with intrahepatic cholestasis syndrome who need hepatoprotection is justified.

[ECONOMIC BURDEN AND CURRENT STATUS OF THE DRUG SUPPLY MANAGEMENT FOR IMMUNE INFLAMMATORY DISEASES (BY EXAMPLE OF ULCERATIVE COLITIS AND CROHN'S DISEASE)].

AIM: to estimate the quality and availability of medical care for patients with ulcerative colitis (UC) and Crohn's disease (CD), to assess the impact of the economic burden of these diseases on the healthcare budget of Russia and to systematize the main problems in the organization of medical care and drug supply for patients with inflammatory bowel diseases (IBD). Regional IBD databases (2016-2018), official statistical databases, costs of treatment and results of expert interviews with specialists in IBD were used in the study. The analyzed databases showed 104,668 patients with UC in Russia in 2018 (prevalence rate 71 per 100,000 people) and 66,647 patients with CD (prevalence rate of 45 per 100,000 people). The economic burden including agents for biologic therapy (ABT) for the UC was 39.54 billion rubles a year (495 rubles per capita), and CD - 32.98 billion rubles a year (378 rubles per capita). It requires an additional 9.87 billion rubles annually for UC and 9.20 billion rubles annually for CD patients to provide the complete supply with ABT. The annual burden of IBD is 72.52 billion rubles, which is comparable to the costs of other socially significant diseases, including malignant tumors. It shows the high social and economic value of IBD for the country. The main problems of medical care and drug supply for IBD patients are the mismatch of official statistical data and real IBD prevalence in Russia due to absence of comprehensive register and the insufficient supply with ABT due to limited funding. A federal center for IBD should be founded for better quality of registration, for the precise monitoring and for the active management of personal drug supply.