Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

The aim of the study was to evaluate the efficacy and safety of Kolofort® (a complex medicine containing technologically processed forms of antibodies to S-100 protein, tumor necrosis factor-α and histamine) in the management of functional dyspepsia (FD) in outpatient clinical practice.Methods: Outpatients (N = 309) at the age of 18–45 in whom FD was diagnosed according to the Rome IV criteria were enrolled in a multicenter, double-blind, placebo-controlled, randomized clinical trial. Patients were randomized in two groups receiving Kolofort® or placebo 2 tablets tid for 8 weeks. The primary endpoint of the study was a change in the FD symptoms severity score according to the Gastrointestinal symptom score (GIS) at week 8. ITT and [PP] analysis were performed.Results: at week 8 the reduction in GIS sum score was observed in Kolofort® group and placebo group (by 7.2 ± 3.3 [7.2 ± 3.4] and 6.3 ± 4.6 [6.2 ± 4.5], respectively, p = 0.041 [0.039]). The proportion of cases with GIS score reduction by ≥4 was 88,1 % [88.6 %] and 79.1 % [79.6 %] in Kolofort® group and placebo group, respectively (p = 0.046 [p = 0.051]). None of the patients in Kolofort® group had progression of FD symptoms or required additional therapy. There were 29 adverse events (AEs) recorded in 25 patients including 16 cases in 13 (8.6 %) patients in Kolofort® group and 13 AEs in 12 (7.6 %) patients in placebo group.Conclusion: the clinical trial demonstrates the positive effect of Kolofort® in FD with a favorable safety profile

Phenotypes of Non-Alcoholic Fatty Liver Disease in Different Regions of the Russian Federation, Diagnostic and Therapeutic Approach in Clinical Practice

Аim: to present data on the prevalence of various phenotypes of non-alcoholic fatty liver disease (NAFLD), the features of its diagnosis and treatment in various regions of the Russian Federation following a meeting of chief gastroenterologists.Key points. Non-alcoholic fatty liver disease (NAFLD) holds the leading position among non-infectious liver diseases in the Russian Federation, its prevalence is 37.3 % and does not tend to decrease.To get information on various aspects of NAFLD diagnosis and treatment, opinion of 18 chief external regional gastroenterologists and leading specialists in the field of liver diseases was studied by analyzing the responses to questions specially formulated for them. Information on the situation in the Ural, Privolzhsky, Southern, Central and Northwestern Federal Districts was obtained. Regional statistics on the prevalence of NAFLD and its certain phenotypes (steatosis, steatohepatitis, cirrhosis), diagnostic instruments and treatment approaches which are used in clinical practice, as well as on the most common associated conditions was presented.Conclusions. The collected information allows to improve both administrative and treatment and diagnostic-related activities in managing patients suffering from this disease

Phenotypes of Non-Alcoholic Fatty Liver Disease in Different Regions of the Russian Federation, Diagnostic and Therapeutic Approach in Clinical Practice

Aim: to present data on the prevalence of various phenotypes of non-alcoholic fatty liver disease (NAFLD), the features of its diagnosis and treatment in various regions of the Russian Federation following a meeting of chief gastroenterologists.Key points. Non-alcoholic fatty liver disease (NAFLD) holds the leading position among non-infectious liver diseases in the Russian Federation, its prevalence is 37.3 % and does not tend to decrease.To get information on various aspects of NAFLD diagnosis and treatment, opinion of 18 chief external regional gastroenterologists and leading specialists in the field of liver diseases was studied by analyzing the responses to questions specially formulated for them. Information on the situation in the Ural, Privolzhsky, Southern, Central and North-western Federal Districts was obtained. Regional statistics on the prevalence of NAFLD and its certain phenotypes (steatosis, steatohepatitis, cirrhosis), diagnostic instruments and treatment approaches which are used in clinical practice, as well as on the most common associated conditions was presented.Conclusions. The collected information allows to improve both administrative and treatment and diagnostic-related activities in managing patients suffering from this disease

Protein-energy status and quality of life at patients HCV - related cirrhosis class A

The purpose of the present work was studying of laws, protein-energy insufficiency (PEI) and indicators of quality of life (QL) at sick virus (HCV) hepatic cirrhosis (HC) class A in the course of antiviral therapy. Object and methods of research: It is spent randomized, prospective, controllable, open research of parameters PEI and indicators QL of sixty patients with virus (HCV) by hepatic cirrhosis class A in the course of antiviral therapy (AVT) with enteral food (EF) and without it. Indicators PEI (an index of weight of a body, a circle of muscles of a shoulder, skinny - a fatty fold on triceps and albumin of blood whey) were analyzed; quality of life of patients was estimated by a method of questioning with application of questionnaire SF - 36. Results: At sick virus (HCV) HC class A protein- energy insufficiency meets already to AVT in 14,8 % of cases. Antiviral therapy sick HCV HC class A is accompanied by increase in relative frequency PEI in group to 61,5 % of patients. An enteral food reduces relative frequency PEI in the course of AVT to 21,4 %, p = 0,0035. Lowered base (before treatment) indicators QL at sick virus (HCV) HC class A in the course of AVT worsens. Indicators of ‘a physical component of health» (SF - 36) and PEI have authentic positive communication (r> 0,46, p 0,46, р < 0,01). Энтеральное питание предотвращает ухудшение «физического компонента здоровья» (SF - 36) в процессе пртивовирусной терапии, р Заключение: В процессе ПВТ больных HCV ЦП класса А усугубление БЭН тре`бует проведения мониторинга её показателей и превентивное назначение энтерального питания

Practical Aspects of Clinical Manifestations, Pathogenesis and Therapy of Alcoholic Liver Disease and Non-alcoholic Fatty Liver Disease: Expert Opinion

Aim: to present the results of an expert discussion of modern aspects of the clinical manifestations, pathogenesis and treatment of alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD).Key points. ALD and NAFLD are characterized by high prevalence and have a significant impact on public health. For the diagnosis of liver pathology, it is important to determine the stage of fibrosis and the severity of the exacerbation of the disease. In the treatment of ALD, it is recommended to achieve abstinence, proper nutrition, the appointment of B vitamins, drugs with cytoprotective activity. In severe hepatitis, corticosteroids may be prescribed. In the treatment of NAFLD, diet and lifestyle modification, weight loss, the use of insulin sensitizers, vitamin E, statins (in the presence of hyperlipidemia) and drugs with metabolic activity are effective.Currently, a point of view is being actively expressed about the synergism of the action of alcohol and the metabolic syndrome on the development of fibrosis, cirrhosis, and hepatocellular carcinoma. The current international consensus recommends a change in the nomenclature of NAFLD and ALD and proposes the terms “metabolically associated steatotic liver disease” and “metabolically associated alcoholic liver disease”.Conclusion. The closeness of the clinical manifestations and pathogenesis of NAFLD and ALD justifies attention to drugs with metabolic activity, which are recommended by the Russian Gastroenterological Association and Russian Scientific Liver Society for the treatment of these diseases. The experts support the suggestion to quantify alcohol consumption in patients with NAFLD in order to change the management of patients, if necessary

Impact of symptoms of eating disorders on the risk of gastrointestinal diseases

The aim of the study - to study the risk of comorbidity of gastrointestinal diseases with eating disordersЦель исследования - изучить влияние симптомов РПП на риск возникновения заболеваний желудочно-кишечного тракта (ЖКТ)

Optimization of antiviral therapy results at sick with chronic hepatitis and with the cirrhosis in its outcome

Purpose. Increasing the efficiency of treatment of a chronic hepatitis С and a cirrhosis in its outcome on the basis of optimization of selecting patients for antiviral therapy with using the integrated prognostic model. Methods. Efficiency of the developed integrated model with use of the module of MAR-SPLINES, for the forecast of results of antiviral therapy is analysed. That model is approved in prospective open controllable research on 36 pa-tients CVG С in comparison with control group of patients (35 people) which selection on AVT was spent taking into account routine predictors. AVT at patients CVG С was spent by short-range interferon and ribaverinum; at patients CVG С with failure AVT and patients with the LC - peg-interferon and ribaverinum. Results. Efficiency of treatment patients CVG С in group, where the prog-nostic model was used at selection of patients on AVT, has made 80,6 % and was on 23,5 % above that in the first group of comparison, p=0,04. Using the peg-interferon at patients CVG C, excluded from report AVT by short-range interferon in a kind of low values of prognostic effectiveness ratio AVT, along with patients sick LC class A, has allowed to reach RVA at 42,9 % of patients. Conclusions. Data of research work proves the possible increasing efficiency of combined AVT by optimization selection of patients on scheme AVT taking into account offered integrated mathematical model.Цель. Повышение эффективности лечения хронического гепатита С и цирроза печени в его исходе на основе оптимизации отбора больных на противовирусную терапию с использованием интегральной прогностической модели. Материал и методы исследования. Проанализирована эффективность разработанной интегральной модели с использованием модуля M AP-сплайнов, для прогноза результатов противовирусной терапии. Данная модель апробирована в проспективном открытом контролируемом исследовании на 36 больных ХВГ С по сравнению с контрольной группой пациентов (35 чел.), отбор которых на ПВТ проводился с учетом рутинных предикторов. ПВТ больных ХВГ С проводилась короткодействующими интерферонами и рибавирином; больных ХВГ С с неблагоприятным исходом ПВТ и пациентов с ЦП - пегилированными интерферонами и рибавирином. Результаты. Эффективность лечения больных ХВГ С в группе, где использовалась прогностическая модель при отборе больных на ПВТ, составила 80,6% и была на 23,5% выше таковой в первой группе сравнения, р=0,04. Использование пегилированного интерферона у больных ХВГ С, исключенных из протокола ПВТ короткодействующими интерферонами в виду низких значений прогностических коэффициентов эффективности ПВТ, наряду с пациентами ЦП класса А , позволило достичь УВО у 42,9% больных. Заключение. Данные исследовательской работы доказывают возможность повышения эффективности комбинированной ПВТ путем оптимизации отбора больных на схему ПВТ с учетом предложенной интегральной математической модели

Antiviral therapy of chronic hepatitis С: achievements and problems. Efficiency prognosis (literature review)

Though there are well-tested treatment protocols available for patients with viral hepatitis, the problem ot response efficiency to antiviral therapy (AVT) still remains urgent. Review contains current standard-of-care antiviral therapy used for patients with chronic hepatitis C. The critical key analysis of different treatment regimens and data from efficiency predictors in this patients category is presented.Несмотря на отработанные в настоящее время стандарты ведения больных вирусными гепатитами, остается актуальной проблема эффективности ответа на противовирусную терапию (ПВТ). В обзоре отражены современные представления о ПВТ, применяющейся у больных хроническим вирусным гепатитом С. Представлен критический анализ различных схем ПВТ и данные о предикторах эффективности лечения у данной категории пациентов

Digestive Disease Mortality Dynamics During New Coronavirus Infection Pandemic in Different Subjects of Russian Federation

Aim. An analysis of digestive disease mortality dynamics in different subjects of the Russian Federation in course of the new coronavirus infection pandemic.Key points. In most subjects of the Russian Federation, the first half of 2021 enduring the COVID-19 pandemic has witnessed a higher overall mortality from digestive diseases and from peptic ulcer, liver and pancreatic illnesses compared to the same period in 2020. This situation may have roots in both the adverse impact of coronavirus infection on pre-existing digestive diseases and shortages in providing specialty medical aid to gastroenterological patients during the pandemic. Improved outpatient care and remote counselling, as well as successful educational measures, may reduce gastroenterological disease-associated mortality.Conclusion. Most regions of Russia have registered a growing mortality from digestive diseases at the new coronavirus infection pandemic due to the SARS-CoV-2 adverse impact on illness progression, as well as imposed difficulties in providing specialty medical aid

Determination of Probiotics Prescription Indications in Patients with Irritable Bowel Syndrome (Materials of the Expert Council and Literature Review)

Aim. To review the main indications for probiotics prescription in patients with irritable bowel syndrome and to present the materials of an Expert Council, which was held on 18 March 2022 in Moscow.Key points. Gut microbiota disturbance is an integral part of irritable bowel syndrome (IBS) pathogenesis. Changes of colonic microbiota composition are associated with its functional potential modification, which leads to an increasing of the pro-inflammatory immune response, as well as to an exacerbation of the disease symptoms and quality of life decreasing in patients with IBS. The novel coronavirus infection (COVID-19) is an independent risk factor for both exacerbation and onset of IBS, which predispose to increase IBS incidence. Correction of gut microbiota composition with probiotics seems to be a promising therapeutic target for IBS treatment optimizing. The optimal probiotic should be effective, safe, strain-specific, and its dose and duration of administration should be confirmed by the results of clinical studies. Some of the probiotics with proven efficacy in IBS are Alflorex® and Enterol®.Conclusion. Prescription of certain probiotics in IBS is advisable to normalize the frequency and consistency of stools, relieve abdominal pain and bloating, as well as improve patients’ quality of life