LIPOSOMAL TECHNOLOGIES FOR SILYBIN DELIVERY TO THE LIVER IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE

Abstract

The aim of the study is to evaluate the effectiveness and safety of liposomal technologies in the treatment of non-alcoholic fatty liver disease (NAFLD) using Silybin (Lipoliv) as an example.
 Materials and Methods. The authors conducted a randomized placebo-controlled study approved by the ethics committee. The study included 111 subjects with NAFLD, aged 18–65. Lipoliv therapy (experimental group) or placebo therapy (control group) lasted for 12 weeks, the trial subjects received 1 capsule per day. The authors evaluated success rates, such as steatohepatitis activity (AST, ALT), severity of liver steatosis (transient elastography with controlled attenuation parameter), quality of life(SF-36 questionnaire); and safety profile: adverse events. Statistical analysis was carried out using the StatTech v. 1.2.0.
 Results. The subjects of the experimental group demonstrated a significant decrease in ALT (p<0.001) and AST (p<0.001) levels as well as in steatosis (p<0.001) after treatment. There was a significant improvement in the parameters of physical and mental well-being in both groups (p<0.001). No adverse reactions or therapy interruption were noted.
 Conclusion. When treating patients with NAFLD, the effectiveness of Silybin, synthesized with liposomal technologies (Lipoliv), was confirmed by a significant decrease in steatohepatitis activity, improved quality of life, and a decrease in steatosis severity. The drug demonstrated a high safety profile.