扶正化瘀胶囊联合恩替卡韦治疗乙型肝炎肝硬化的Meta分析

A meta-analysis of Fuzheng huayu capsule combined with entecavir in the treatment of hepatitis B cirrhosis

目的:系统评价扶正化瘀胶囊联合恩替卡韦治疗乙型肝炎肝硬化的疗效及安全性。方法:计算机检索Medline、Pubmed、中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普(VIP)及万方(WanFang)等数据库,搜集扶正化瘀胶囊联合恩替卡韦治疗乙型肝炎肝硬化的随机对照试验(RCT)。采用Rev Man 5.3软件对所提取的数据资料进行Meta分析。结果:共纳入15项研究、1491例研究对象,其中观察组患者748例,对照组患者743例。对各疗效指标进行效应量合并,肝纤维化指标:PCⅢ[SMD=-2.44,95%CI(-3.94,-0.95),Z=3.21,P=0.001],LN[SMD=-1.86,95%CI(-3.42,-0.30),Z=2.33,P=0.002],HA[SMD=-2.13,95%CI(-3.62,-0.63),Z=2.78,P=0.005],Ⅳ-C[SMD=-1.63,95%CI(-3.26,-0.00),Z=1.96,P=0.05];肝功能指标:ALT[SMD=-2.51,95%CI(-4.26,-0.76),Z=2.81,P=0.005],AST[SMD=-0.94,95%CI(-1.12,0.76),Z=10.09,P=0.00001],且尚未发现明显不良反应。两组患者血清HBV DNA转阴率方面差异无统计学意义(P>0.05)。结论:扶正化瘀胶囊联合恩替卡韦治疗能改善乙型肝炎肝硬化患者肝纤维化指标及肝功能,临床疗效优于单用恩替卡韦,且安全性高。

Objective:To evaluate the efficacy and safety of Fuzheng huayu capsule combined with entecavir in the treatment of hepatitis B cirrhosis.Methods:The randomized controlled trial of Fuzheng huayu capsule combined with entecavir in the treatment of hepatitis B cirrhosis was collected from Medline,Pubmed,CNKI,CBM,VIP,and WanFang databases by computer.The retrieval time was from the establishment of the database to April 2019.Two researchers independently screened,extracted,and evaluated literature quality according to inclusion and exclusion criteria.Rev Man 5.3 software was used for meta-analysis of the extracted data.Results:A total of 15 studies were included,including 1,491 subjects,including 748 in the observation group and 743 in the control group.Combined effect amount of all therapeutic indexes,liver fibrosis index:PCⅢ[SMD=-2.44,95%CI(-3.94,-0.95),Z=3.21,(P=0.001)],LN[SMD=-1.86,95%CI(-3.42,-0.30),Z=2.33,(P=0.002)],HA[SMD=-2.13,95%CI(-3.62,-0.63),Z=2.78,(P=0.005)],ⅣC[SMD=-1.63,95%CI(-3.26,-0.00),Z=1.96,(P=0.05)].Liver function index:ALT[SMD=-2.51,95%CI(-4.26,-0.76),Z=2.81,(P=0.005)],AST[SMD=-0.94,95%CI(-1.12,0.76),Z=10.09,(P=0.00001)].There was no significant difference in the improvement of serum HBV-DNA negative conversion rate between combination and entecavir alone(P>0.05).Conclusion:Fuzheng huayu capsule combined with entecavir can not only reduce the liver fiber index of patients with hepatitis B cirrhosis but also improve the liver function.