Efficiency and safety of ademetionine in the correction of liver function in patients with steatohepatitis. Results of an open multicenter comparative post-marketing study
Journal Title: Сучасна гастроентерологія - Year 2019, Vol 0, Issue 1
Abstract
Objective — to study the efficacy and safety of the drug ademetionine, lyophilisate for solution for injection in patients with non-alcoholic steatohepatitis (NASH). Materials and methods. The examinations involved 120 patients with NASH, who were divided into two groups. Patients of the main group (35 men and 27 women, mean age 49.0 ± 2.1 years) were administered ademetionionine generic drug Hepamethion (Arterium) in a dose of 400 mg intravenously daily for 2 weeks, subjects of the comparison group (34 men and 24 women, mean age 52.0 ± 2.3 years) received as a referent preparation the original ademetionine preparation «Heptral» in a dose of 400 mg intravenously daily for 2 weeks. The groups were gender-, age-, and metabolic indices matched (p > 0.05). The diagnosis of non-alcoholic fatty liver disease was established in accordance with international and national protocols and standards for its diagnosis. The level of depression was determined by the method of questioning using the standard Beck questionnaire. Results. Against the background of the ademetionine administration in patients with NASH, there was a significant positive dynamics in the indices of cytolysis (p < 0.05) and inflammation, tumor necrosis factor-α (p < 0.001) already on the 18—22nd days and on 48—52nd days of therapy vs baseline, and relief of depression signs, as evidenced by a significant decrease in the level of depression (p < 0.001). Conclusions. The results of the use of ademetionine enable to positively evaluate its effects in patients with NASH as a pathogenetic drug with an additional pronounced antidepressant effect. The investigated generic ademetionine preparation was comparable to the reference drug (p > 0.05).
Authors and Affiliations
G. D. Fadieienko, I. M. Skrypnyk, G. V. Oisodlo, O. E. Gridnev, Ya. V. Nikiforova
Keywords
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- EP ID EP492757
- DOI 10.30978/MG-2019-1-13
- Views 122
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