苦参碱注射液治疗慢性乙型肝炎患者的临床疗效及安全性Meta分析

Clinical efficacy and adverse effects of matrine injection on chronic hepatitis B patients with anti-virus therapy by meta-analysis

目的:用循证医学方法探索苦参碱注射液治疗抗病毒慢性乙型肝炎患者的临床疗效及安全性。方法:收集2016年12月以前CNKI、CBM、维普、万方、Pub Med数据库、Cochrane图书馆、OVID数据库苦参碱注射液治疗慢性乙型肝炎患者的临床试验资料,文章的质量评分用Cochrane系统评价的方法。利用Rev Man5.3软件对多个研究结果进行Meta分析。结果:共纳入23篇RCTs文献,Meta分析结果示:苦参碱注射液可增加51%的HBe Ag阴转率[RR=1.51,95%Cl(1.38,1.64),P<0.00001];增加39%的HBV-DNA阴转率[RR=1.39,95%Cl(1.28,1.50),P<0.00001];增加84%的HBs Ag阴转率[RR=1.84,95%Cl为(1.27,2.68),P=0.001];增加45%抗HBe阳转率[RR=1.45,95%Cl为(1.26,1.67),P<0.00001];降低45%的白细胞、血小板下降的发生风险[RR=0.55,95%Cl(0.36,0.85),P=0.007];ALT复常率、流感样症候群结局无明显差别。结论:苦参碱注射液可提高抗病毒乙肝患者的临床疗效及降低不良反应。

Objective：To explore effects and the safety of matrine （Mat） injection on chronic hepatitis B （CHB） patients with anti-virus therapy by conducting a meta-analysis and the method of evidence-based medicine. Methods： We performed a systematic search in CNKI, CBM, VIP, Wanfang, PubMed, Cochrane library and OVID to identify all trials related to effects of matrine on CHB before December 2016. The qualities of trials were assessed by cochrane systematic review. Results of articles were evaluated by meta analysis in the RevMan 5.3 software. Re- suits： Twenty-three studies were included. Matrine could improve HBeAg negative conversion rate （RR = 1.51,95% Cl 1.38 to 1.64, P 〈0. 00001 ）, HBV-DNA negative conversion rate （ RR = 1.39, 95% Cl 1.28 to 1.50, P 〈 0.00001 ）, HBsAg negative conversion rate （ RR = 1.84,95 % Cl 1.27 to 2.68, P = 0.001 ）, Anti-HBe conversion rate （ RR = 1.45,95 % Cl 1.26 to 1.67, P 〈 0.00001 ） and reduce the risk of leucopenia and thrombocytopenia （RR = 0.55,95 % Cl 0.36 to 0. 85, P = 0. 007）. However, there were no differences in ALT recovery rate and the risk of influenza-like symptoms. Conclusion ： This systematic review revealed that matrine injection in CHB patients with anti-virus therapy had better clinical efficacy and less risk of adverse effects.