The Efficacy And Safety Of Obeticholic Acid For The Treatment Of Non-alcoholic Steatohepatitis: A Meta-analysis

ObjectiveA comprehensive and systematic review of the effectiveness and safety of published obeticholic acid(OCA)in the treatment of non-alcoholic steatohepatitis(NASH)through META analysis is provided Treatment of NASH provides new treatments to maximize prognosis and delay disease progression.MethodsComprehensive retrieval of the RCTS for the treatment of NASH by OCA was conducted in Pubmed,Cochrame Library,Embase,cnki,wanfang database and weipu database.Strict literature screening was conducted according to the established inclusion and exclusion criteria.RevMan5.3 software was used to conduct systematic data consolidation analysis and draw forest maps to obtain scientific evidence-based conclusions on the effectiveness and safety of OCA in treating NASH.ResultsFinally,4 English multicenter RCT documents were included,and these 4documents were all high-quality documents with a total of 1684 patients.Meta analysis results are as follows:1.Compared with the placebo group,the experimental group of OCA 25mg/day significantly improved liver histology(RR=1.45,95%CI[1.31,1.60],P<0.00001).Among them,liver fibrosis,hepatic steatosis,hepatic lobular inflammation,and hepatocyte ballooning were all significantly improved(P?0.001).Except for hepatic steatosis,the heterogeneity is slightly larger(I~2=62%),and the other heterogeneity is very small or even 0%.2.OCA 25mg/day experimental group significantly improved liver function indicators ALT,AST and GGT(P<0.0001),but ALP was aggravated(P<0.00001).3.The OCA 25mg/day experimental group increased the lipid indexes LDL and TC(P<0.05),decreased HDL(P=0.03),and had no statistical significance in TG(P=0.32).4.In terms of safety,the incidence of adverse reactions in the skin and subcutaneous tissue(mainly itching of the skin)and gastrointestinal tract of the experimental group of OCA 25 mg/day was statistically significant(P<0.01).However,in the nervous system,there was a higher incidence of adverse reactions in the placebo group(P=0.02).There was no significant difference between the infection group,the cardiovascular system,and the musculoskeletal and connective tissue groups compared with the placebo group.Conclusions1.OCA treatment of NASH can reduce its NAS score and significantly improve the degree of fibrosis,steatosis,hepatic lobular inflammation and hepatocyte ballooning,which may reverse the degree of NASH liver fibrosis.2.OCA treatment of NASH can improve serum liver function indicators ALT,AST,GGT,suggesting that it helps to improve liver function.3.OCA treatment of NASH can increase serum LDL and TC indicators and reduce serum HDL indicators,suggesting that it has an adverse effect on blood lipids.4.OCA treatment of NASH main adverse reactions are skin and subcutaneous tissue(mainly itching of the skin)and gastrointestinal adverse reactions.No OCA-related deaths occurred.