南方医科大学学报 ›› 2014, Vol. 34 ›› Issue (08): 1224-.

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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

陈建蓉,王霁,秦天强,黄艳,李静   

  • 出版日期:2014-08-20 发布日期:2014-08-20

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

  • Online:2014-08-20 Published:2014-08-20

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。

Abstract: 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% CI: 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.