Results of multicenter double blind randomized placebo-controlled post-registration clinical study (IV phase)

Ивашкин, В. Т.; Бакулин, И. Г.; Богомолов, П. О.; Мациевич, М. В.; Гейвандова, Н. И.; Корой, П. В.; Недогода, С В; Саблин, О. А.; Ленская, Л. Г.; Белобородова, Е. В.; Багрецова, А. А.; Абдулхаков, Р. А.; Осипенко, М. Ф.; Осипова, И. В.; Почепцов, Д А; Чумачек, Е. В.; Хромцова, О. М.; Кузьмичева, Е. В.

doi:10.22416/1382-4376-2017-27-2-34-43

Cited by 6 publications

(1 citation statement)

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“…После завершения полного курса терапии у пациентов основной группы был зафиксирован более высокий средний балл по шкале «Уровень жизненной энергии» (5,9 ± 1,0 против 5,6 ± 1,0; р = 0,034). На фоне терапии зарегистрированы лишь единичные нежелательные явления, статистически значимых различий в их частоте между группами не выявлено [7]. Все эти позитивные данные дают основания для широкого применения препаратов глицирризина в клинической практике.…”

Section: принципы рационального выбора полипотентных молекулunclassified

Features of the therapy of non-alcoholic fatty liver disease in comorbid patients

Маевская

2021

Medicinskij sovet

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The problem of modern medicine and modern society is a comorbid patient with metabolic disorders. Hypothetical portrait of such a patient: over 40 years old, overweight, arterial hypertension, coronary atherosclerosis, impaired carbohydrate and lipid metabolism, liver steatosis or steato-hepatitis, often with changes in the function of the musculoskeletal system. Rational pharmacotherapy of this patient is of fundamental importance. The article analyzes, from the point of view of polypotency, efficacy and safety, the main drugs used in Russia for treatment of non-alcoholic fatty liver disease in comorbid patients. Attention is paid to vitamin E, glycyrrhizin, ursodeoxycholic acid. Domestic and foreign studies of these drugs are analyzed, and the scope of their rational use is shown: reducing the risk of cardiovascular complications, a positive effect on the lipid spectrum, reducing the activity of serum transaminases and other hepatotropic effects. Their side effects are also considered, which should be taken into account when choosing the treatment of a comorbid patient. We have analyzed the efficacy and safety of new molecules that are in clinical trials and/or have not yet been registered in our country, e.g. obeticholic acid, cenicriviroc, tropifexor, etc. The ability of some molecules to act as biological enhancers is also highlighted, which is important to consider when prescribing combination therapy. Doctors are recommended to carefully consider and take into account all the features of a comorbid patient and choose for this category of patients safe drugs of hepatotropic action with simultaneous positive effect on the cardiovascular system. Among other things, it will avoid polypragmasy.

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Section: принципы рационального выбора полипотентных молекулunclassified

Features of the therapy of non-alcoholic fatty liver disease in comorbid patients

Маевская

2021

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Efficacy and Safety of a Fixed Combination of Glycyrrhizic Acid and Essential Phospholipids in Non-Alcoholic Fatty and Alcoholic Liver Disease: Results from Randomized Placebo-Controlled Trials

2021

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Background. Drug treatment of non-alcoholic fatty and alcoholic liver disease remains an urgent, unsolved problem. Due to the commonality of many pathogenetic mechanisms and predictors of progression, a universal approach to the search for a therapeutic agent can be considered. Aims pooled analysis of the results of two multicenter, randomized, double-blind, placebo-controlled studies of a fixed combination of glycyrrhizic acid and essential phospholipids in two dosage forms to study its efficacy and safety in non-alcoholic fatty and alcoholic liver disease, in the presence and absence of predictors of disease progression. Methods. The pooled analysis included 180 patients with non-alcoholic fatty liver disease (Gepard study) and 120 patients with alcoholic liver disease (Jaguar study). Patients of the main group received a fixed combination of 5.0 g intravenous jet 3 times a week for the first 2 weeks; then 2 capsules 3 times a day for the next 10 weeks. Patients in the control group received placebo according to the same scheme. The total duration of treatment was 12 weeks in the Gepard study (1 course of stepwise therapy) and 24 weeks in the Jaguar study (2 courses of stepwise therapy). A comparative analysis of the efficacy and safety of a fixed combination and a placebo was carried out, in the presence and absence of predictors of progression, separately for each nosology and in a mixed sample. Results. In patients with non-alcoholic fatty and alcoholic liver disease who received the fixed combination, in contrast to the placebo group, there was a statistically more significant decrease in the level of biochemical markers of inflammation alanine aminotransferase, aspartate aminotransferase, adiponectin, and the value of the AktiTest index. There was no negative trend in the NAFLD fibrosis score; more significant positive dynamics of FibroTest is shown. Predictors of disease progression hyperglycemia, hyperlipidemia, age did not have a negative impact on the results in the study group. The efficacy of the study drug was noted in patients with non-alcoholic fatty liver disease and normal body weight; data were obtained indicating its possible effectiveness with a high activity of the inflammatory process associated with alcoholic liver damage. The frequency of adverse events in the study and control groups was comparable. Conclusions. Based on a generalized analysis of the results of two studies, promising directions for the study and use of a fixed combination of glycyrrhizic acid and essential phospholipids were identified: non-alcoholic fatty liver disease without obesity, alcoholic steatohepatitis of high activity (as an adjuvant); steatohepatitis of non-alcoholic and alcoholic etiology, combined with hyperglycemia and hyperlipidemia.

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Non-alcoholic fatty liver disease and psoriasis: mechanisms of comorbidity and approaches to therapy

Livzan,

Gaus,

Ekimov

2024

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Psoriasis is a chronic immune-mediated skin disease of a multifactorial nature, characterized by accelerated proliferation of keratinocytes and impaired differentiation, an imbalance between pro-inflammatory and anti-inflammatory cytokines, with frequent involvement of the musculoskeletal system in the pathological process. The etiology of psoriasis is unknown, but several risk factors have been identified, including family history, smoking and obesity. The high prevalence of obesity, diseases of the cardiovascular system and digestive organs in patients with psoriasis allows us to consider it as an indicator of the patient’s metabolic disorders. In the structure of comorbidity of patients with psoriasis, special attention is drawn to non-alcoholic fatty liver disease (NAFLD), which occupies a leading position in the structure of the incidence of chronic diffuse liver diseases among the adult population in many countries of the world, including Russia. Patients with psoriasis are more often diagnosed with NAFLD, regardless of the presence of metabolic syndrome and other traditional risk factors. The presence of NAFLD is associated with more severe psoriasis and worse outcomes. On the other hand, a negative effect of psoriasis on the course of liver pathology has been noted. In this regard, it seems particularly relevant to study the etiological factors and pathogenetic links underlying this comorbidity, as potential targets for targeted therapy, which can improve the effectiveness of treatment for this cohort of patients. The purpose of this review publication is to summarize and systematize the available data on the prevalence of comorbidity of psoriasis and NAFLD in the population, the mechanisms of its formation and approaches to patient management.

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Results of multicenter double blind randomized placebo-controlled post-registration clinical study (IV phase)

Cited by 6 publications

References 0 publications

Features of the therapy of non-alcoholic fatty liver disease in comorbid patients

Features of the therapy of non-alcoholic fatty liver disease in comorbid patients

Efficacy and Safety of a Fixed Combination of Glycyrrhizic Acid and Essential Phospholipids in Non-Alcoholic Fatty and Alcoholic Liver Disease: Results from Randomized Placebo-Controlled Trials

Non-alcoholic fatty liver disease and psoriasis: mechanisms of comorbidity and approaches to therapy

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