六味五灵片治疗非酒精性脂肪性肝病疗效的Meta分析

Clinical efficacy of Liuweiwuling tablets in treatment of non- alcoholic fatty liver disease: a meta- analysis

目的系统评价六味五灵片治疗非酒精性脂肪性肝病(NAFLD)的有效性,为临床提供循证医学依据。方法在Cochrane图书馆、CNKI、万方、Pub Med数据库检索已发表的关于六味五灵片治疗NAFLD的文献,截止日期为2015年1月30日。筛选出六味五灵片联合常规治疗与单独常规治疗NAFLD的随机对照试验(RCT),对纳入的文献进行质量评价和资料提取,采用RevMan 5.2对ALT、AST、GGT、甘油三酯(TG)、临床治疗总有效率和影像学指标改善情况进行Meta分析。结果共纳入6篇RCT,包括试验组228例,对照组205例。分析显示:试验组的ALT、AST、GGT及TG下降幅度均大于对照组,差异具有统计学意义[标准化均数差(SMD)分别为-1.29、-1.15、-1.47、-0.48,95%可信区间(95%CI)分别为-1.69^-0.89、-1.85^-0.45、-1.68^-1.25、-0.60^-0.35,P值均<0.01];治疗结束后试验组的临床总有效率和影像学指标改善情况明显高于对照组,差异具有统计学意义[相对危险度(RR)分别为1.48、1.43,95%CI分别为1.29~1.70、1.21~1.68,P值均<0.01]。结论在常规治疗基础上加用六味五灵片可显著改善NAFLD患者的肝功能,降低血脂水平,提高临床总有效率。但由于纳入文献质量较低,当前荟萃分析结论的可靠性应被进一步验证。

Objective To systematically evaluate the clinical efficacy of Liuweiwuling tablets in the treatment of non- alcoholic fatty liver disease（ NAFLD）,and to provide an evidence- based medicine basis for its clinical application. Methods Literature about Liuweiwuling tablets in the treatment of NAFLD published up to January 30,2015 was searched for in Cochrane Library,CNKI,Wanfang Data,and Pub Med. And the randomized controlled trials（ RCTs） of Liuweiwuling tablets combined with conventional therapy（ experimental group）versus conventional therapy（ control group） for NAFLD were included in the analysis. The quality of included studies was assessed,and the data were extracted. And then they were subjected to meta- analysis using Rev Man 5. 2 to analyze the improvements in alanine aminotransferase（ ALT）,aspartate aminotransferase（ AST）,gamma- glutamyl transpeptidase（ GGT）,triglyceride（ TG）,clinical overall response rate,and imaging indices. Results A total of six RCTs were included in the analysis,involving 228 cases in the experimental group and205 cases in the control group. The analysis results showed that the experimental group had significantly reduced levels of ALT,AST,GGT,and TG compared with the control group（ standardized mean difference [SMD] =- 1. 29,95% confidence interval [CI]：- 1. 69 ^- 0. 89,P 〈0. 01; SMD =- 1. 15,95% CI：- 1. 85 ^- 0. 45,P 〈0. 01; SMD =- 1. 47,95% CI：- 1. 68 ^- 1. 25,P 〈0. 01; SMD =- 0. 48,95% CI：- 0. 60 ^- 0. 35,P 〈0. 01）. The experimental group had significantly higher clinical overall response rate and better improvements in imaging indices than the control group（ relative risk [RR]= 1. 48,95% CI： 1. 29- 1. 70,P 〈0. 01; RR = 1. 43,95%CI： 1. 21- 1. 68,P 〈0. 01）. Conclusion For patients with NAFLD,Liuweiwuling tablets combined with conventional therapy can significantly improve the liver function,reduce the blood lipid level,and increase the clinical overall response rate. However,since the quality of included literature is low,the reliability of the current meta- analysis conclusions should be further verified.