复方甘草酸苷治疗慢性乙型肝炎的效果及安全性的meta分析  

Efficacy and safety of Stronger Neo-Minophagen C for treatment of chronic hepatitis B: a meta-analysis of randomized controlled trials

作　　者：陈建蓉[1] 王霁[1] 秦天强 黄艳[1] 李静[1] 

机构地区：[1]四川大学华西医院循证医学与临床流行病学教研室,四川成都610041

出　　处：《南方医科大学学报》2014年第8期1224-1229,共6页Journal of Southern Medical University

摘　　要：目的系统评价复方甘草酸苷(SNMC)治疗慢性乙型肝炎的疗效和安全性。方法计算机检索EMBASE、MEDLINE、CNKI、CBM,从建库至2012年12月,纳入SNMC治疗慢性乙肝的随机对照试验(RCT)。两名评价者独立筛选试验;提取资料和按照Cochrane评价者手册评价偏倚风险。Meta-分析采用RevMan 5.1软件。结果纳入31篇RCT,共2753例患者。Meta分析显示:SNMC可改善患者肝功能ALT(MD=-31.63,95%CI:-51.57,-11.70)、AST(MD=-18.70,95%CI:-25.10,-12.30)、TBIL(MD=-12.17,95%CI:-17.63,-6.71)和肝纤维化HA(MD=-94.89,95%CI:-125.19,-64.60)、LN(MD=-40.08,95%CI:-52.38,-27.78)、IV-C(MD=-50.61,95%CI:-63.40,-37.81);PC-Ⅲ(MD=-49.71,95%CI:-71.72,-27.69)情况,组间差异有统计学意义。试验组HBeAg(OR=2.23,95%CI:1.70,2.94)、HBV-DNA(OR=2.20,95%CI:1.70,2.84)、HBsAg(OR=2.25,95%CI:1.24,4.07)的阴转率,总有效率(OR=4.37,95%CI:2.62,7.28)和ALT复常率(OR=3.77,95%CI:2.46,5.79)均高于对照组,差异有统计学意义。结论 SNMC治疗慢性乙型肝炎在肝功能恢复、肝纤维化指标改善、乙肝标志物阴转率等方面均优于对照组,且无严重不良反应。但受纳入文献质量限制,以上结论尚需高质量临床试验进一步证实。Objective To compare the efficacy and safety of Stronger Neo-Minophagen C （SNMC） in the treatment of chronic hepatitis B. Methods We searched MEDLINE, EMBASE, CBM, and CNKI up to December, 2012 to identify randomized controlled trials （RCTs） comparing Stronger Neo-Minophagen C plus other therapy versus others therapy for chronic hepatitis B. Two reviewers independently assessed the risk of bias and extracted data from the included RCTs according to the Cochrane Reviewer＇ s Handbook 5.1.0. Meta-analyses were performed using RevMan 5.1 software. Results Thirty-one trials involving 2753 patients were included in the analysis. The results of meta-analyses showed that SNMC improved hepatic functions of the patients by reducing ALT （MD=-31.63,95% CI..-51.57,-11.70）, AST （MD=-18.70, 95% CI：-25.10,-12.30）, TBIL （MD=-12.17, 95% CI：-17.63,-6.71）, HA （MD=-94.89, 95% CI：-125.19,-64.60）, LN （MD=-40.08, 95% CI：-52.38,-27.78）, IV-C （MD=-50.61, 95% CI：-63.40,-37.81）, PC-III （MD=-49.71, 95% CI：-71.72,-27.69） as compared with the control group. The seroconversion rate of HBeAg （OR=2.23, 95% CI： 1.70, 2.94）, HBV-DNA （OR=2.20, 95% Ch 1.70, 2.84）, HBsAg （OR=2.25, 95% CI： 1.24, 4.07）, total response rate （OR=4.37, 95% CI： 2.62, 7.28）, and ALT normalization rate （OR=3.77, 95% CI： 2.46, 5.79） were all significantly higher in the combined therapy group than in the control group. Conclusion SNMC plus other therapy is more effective than other therapy alone in improving the hepatic function and hepatic fibrosis and increasing hepatic seroconversion rate in patients with chronic hepatitis B without causing serious adverse events. But considering the low quality of the included studies, the results should be interpreted with caution and awaits further confirmation by high-quality, large-scale RCTs.

关 键 词：复方甘草酸苷 SNMC 慢性乙型肝炎 META分析 系统评价 随机对照试验 

分 类 号：R512.62[医药卫生—内科学]