化滞柔肝颗粒治疗非酒精性脂肪性肝病疗效的系统评价和Meta分析

Systematic evaluation and Meta-analysis of the efficacy of Huazhi Rougan granule in the treatment of non-alcoholic fatty liver disease

目的:系统评价化滞柔肝颗粒治疗非酒精性脂肪性肝病(Non-alcoholic Fatty Liver Disease,NAFLD)的疗效和安全性。方法:计算机检索中国知识资源总库(CNKI)、中文科技期刊数据库(维普网)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、Cochrane Library、PubMed、Web of Science、Embase和Scopus,并手工检索。检索范围为建库至2020年11月。收集基础治疗结合化滞柔肝颗粒治疗NAFLD(试验组),对比基础治疗结合其他药物治疗的临床随机对照试验(Randomized Controlled Trials,RCTs),提取资料并运用Cochrane协作网偏倚风险评估工具进行质量评价,采用RevMan5.4进行Meta分析。结果:共纳入13个RCTs,涉及患者1651例。Meta分析结果显示,与对照组相比,试验组总有效率[比值比(Odds Ratiio,OR)=3.40,95%置信区间(Confidence Interval,CI)[2.51,4.61],P <0.000 01)]、谷丙转氨酶(Alanine Transaminase,ALT)[均属差(Mean Difference,MD)=-16.15,95%CI[-26.01,-6.29],P=0.001)]、谷草转氨酶(Aspartate Transaminase,AST)(MD=-14.03,95%CI[-21.05,-7.02],P <0.001)、总胆固醇(Total Cholestorel,TC)(MD=-0.74,95%CI[-1.00~-0.47],P <0.000 01)、甘油三酯(Triglyceride,TG)(MD=-0.32,95%CI[-0.51,-0.13],P=0.000 8)、BMI(MD=-1.81,95%CI[-2.82~-0.80],P=0.000 4)差异具有统计学意义;而γ-谷氨酰转移酶(γ-glutamyl Transpeptidase,γ-GGT)(MD=-3.61,95%CI[-7.44,0.21],P=0.06)、不良反应(RR=0.84,95%CI[0.48,1.47],P=0.54)差异不具有统计学意义。结论:化滞柔肝颗粒治疗非酒精性脂肪性肝病的疗效优于对照组,且具有一定的安全性,但需更多高质量RCT进行验证。

Objective:To evaluate the efficacy and safety of Huazhi Rougan granules(化滞柔肝颗粒)in the treatment of nonalcoholic fatty liver disease(NAFLD).Methods:CNKI,VIP,CBM,Wanfang database,Cochrane Library,PubMed,Web of Science,Embase and Scopusand from establishment to November 2020 were searched for randomized controlled trials(RCTs)on Huazhi Rougan granules combined with basic treatment for NAFLD(the experimental group)versus other medicine with basic treatment of NAFLD(the control group).All included researches were assessed using the Cochrane Collaboration Risk Bias Evaluation Tool and meta-analysis was conducted using RevMan5.4.Results:Totally 13 RCTs were included,involving 1651 patients.Results of meta-analysis showed that the experimental group could improve the efficiency of treatment odds ratiio(OR)=3.40,95%confidence interval(CI)[2.51,4.61],P<0.000,01),and alanine aminotransferase(ALT)mean difference(MD)=-16.15,95%CI[-26.01,-6.29],P=0.001),aspartate aminotransferase(AST)(MD=-14.03,95%CI[-21.05,-7.02],P<0.001),serum total cholesterol(TC)(MD=-0.74,95%CI[-1.00,-0.47],P<0.000,01),triglyeride(TG)(MD=-0.32,95%CI[-0.51,-0.13],P=0.0008),body mass index(BMI)(MD=-1.81,95%CI[-2.82,-0.80],P=0.0004)were descended more significantly than that of the control group,the difference was with statistical significance(P<0.05).Butγ-glutamyl transpeptidase(γ-GGT)(MD=-3.61,95%CI[-7.44,0.21],P=0.06)and the rates of total adverse reactions of the experimental and the control group relative risk(RR)=0.84,95%CI[0.48,1.47],P=0.54)showed no statistically significant difference.Conclusion:Huazhi Rougan granules show better efficacy and certain safety in the treatment of NAFLD than the control group;however,higher quality RCTs are needed to verify the effect.