Meta-Analysis and GRADE Evaluation on Efficacy and Safety of Statins in the Treatment of Non-Alcoholic Fatty Liver Disease
OBJECTIVE:To systematically review the efficacy and safety of statins in the treatment of non-alcoholic fatty liver disease(NAFLD),so as to provide reference for rational drug use in clinic.METHODS:Randomized controlled trials(RCT,the observation group was treated with statins,while the control group received non-statins or placebo and lifestyle intervention)of statins in the treatment of NAFLD were collected through PubMed,Embase,the Cochrane Library,MEDLINE,CBM,Wangfang Data,CNKI,VIP and other databases.There was no limitation on the variety,dosage and treatment duration of statins,and the retrieval time was from the establishment of the database to Jul.2022.Two evaluators screened literature according to inclusion and exclusion criteria and extracted data.RevMan 5.4 and GRAED pro3.6 software were used to analyze the data.RESULTS:A total of 7 RCT(6 in Chinese and 1 in English)were included,and a total of 1 121 NAFLD patients were enrolled.Results of Meta-analysis showed that compared with control interventions,statins significantly reduced levels of liver enzyme in NAFLD patients(alanine transaminase:WMD=-10.45,95%CI=-15.49--5.41,P<0.000 1;aspartate transaminase:WMD=-9.59,95%CI=-13.03--6.15,P<0.000 01;γ-glutamyl transferase:WMD=-6.37,95%CI=-9.90--2.84,P=0.000 4),improved the levels of blood lipid indicators(total cholesterol:WMD=-0.80,95%CI=-1.07--0.53,P<0.000 01;triacylglycerol:WMD=-0.32,95%CI=-0.41--0.24,P<0.000 01;low density lipoprotein cholesterol:WMD=-0.59,95%CI=-1.03--0.15,P=0.009;high density lipoprotein cholesterol:WMD=0.54,95%CI=0.15-0.93,P=0.007),improved liver histological changes(OR=2.79,95%CI=1.59-4.90,P=0.000 4),the differences were statistically significant.In terms of safety,no severe adverse drug reactions occurred in both groups,and the difference in the incidence of adverse drug reactions between two groups was not statistically significant(OR=1.00,95%CI=0.44-2.27,P>0.05).In sensitivity analysis,the results were robust except for low density lipoprotein cholesterol.Results of GRADE evidence assessment showed that triacylglycerol was of intermediate quality of evidence,and other outcome measures were of low or very low quality of evidence.CONCLUSIONS:Based on the situation of this study,statins play a positive role in the treatment of NAFLD,and can reduce liver enzymes,improve lipid levels and liver fat infiltration degree,and are well tolerated.However,the number of included studies in this study is insufficient and the studies on statins varieties,administration doses and multiple potential drug interactions are insufficient,so further studies are needed in the future.