Efficacy of human placenta hydrolyzate in the treatment of patients with metabolic associated fatty liver disease at the stage of fibrosis (pilot study)

Abstract

Background. Despite active research, drug treatment options for metabolic associated fatty liver disease (MAFLD) are limited, and there are no currently approved drugs for patients with MAFLD. Treatment of patients at risk of developing non-alcoholic steatohepatitis and progressive liver fibrosis (LF) is of particular relevance, since they determine the clinical outcomes of the disease. Aim. To evaluate the clinical efficacy of complex polypeptide drug (CPD), human placenta hydrolyzate, containing low molecular weight regulatory peptides, amino acids, vitamins, macro- and microelements in patients with MAFLD at the LF stage. Materials and methods. A single-center, placebo-controlled pilot study. Patients with MAFLD at LF stage 1≤F≤3 according to METAVIR were included (n=10, of which 8 were women, median age was 55 years old). Patients were randomized into 2 groups: 5 people received CPD therapy for 12 weeks (intravenous infusion of 6 ml 2 times a week); another 5 people initially received placebo x 2 times a week (12 weeks), with transfer to the open phase for CPD therapy in the same regimen. The dynamics laboratory and instrumental data was assessed, as well as determine the presence of fibrosis by non-invasive tests – measurement of liver stiffness by transient elastography and use of serum biomarker (SM) by FibroTest and detection of steatosis with controlled attenuation parameter for transient elastography and SM by SteatoTest. The quality of life of patients was assessed using questionnaire SF-36 and well-being via Visual Analogue Scale. Statistical processing of the material was carried out using the methods of nonparametric analysis, using the Statistica 13.3 software. Results. Patients in the CPD group compared with the baseline data and with the placebo group showed a statistically significant improvement: 1) transaminases (ALT, AST), lipid profile indicators (cholesterol), ferritin; 2) indicators of LF, based on a decrease in liver stiffness by transient elastography and SM of Fibrotest, as well as the degree of steatosis based on controlled attenuation parameter and SM of Steatotest; 3) in well-being and quality of life (according to testing: SF-36 physical, mental well-being and general condition of the VAS). CPD was well tolerated, no side effects were noted. Conclusion. In patients with MAFLD during CPD therapy, a decrease in the level of liver enzymes was noted, as well as in LF and liver steatosis according to noninvasive methods. Randomized controlled trials are required to confirm these findings.