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强力新(Stronger Neo-Minophagen C)治疗慢性乙型肝炎的疗效和安全性:随机对照试验的荟萃分析

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

作者信息

Chen Jianrong, Wang Ji, Qin Tianqiang, Huang Yan, Li Jing

机构信息

Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu 610041, China.E-mail:

出版信息

Nan Fang Yi Ke Da Xue Xue Bao. 2014 Jul;34(8):1224-9.

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 Reviewers 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.

摘要

目的

比较强力新C(SNMC)治疗慢性乙型肝炎的疗效和安全性。

方法

检索截至2012年12月的MEDLINE、EMBASE、中国生物医学文献数据库(CBM)和中国知网(CNKI),以识别比较强力新C联合其他疗法与其他疗法治疗慢性乙型肝炎的随机对照试验(RCT)。两名评价员根据Cochrane系统评价员手册5.1.0独立评估偏倚风险并从纳入的RCT中提取数据。使用RevMan 5.1软件进行荟萃分析。

结果

纳入分析的有31项试验,涉及2753例患者。荟萃分析结果显示,与对照组相比,SNMC通过降低谷丙转氨酶(ALT)(MD=-31.63,95%可信区间:-51.57,-11.70)、谷草转氨酶(AST)(MD=-18.70,95%可信区间:-25.10,-12.30)、总胆红素(TBIL)(MD=-12.17,95%可信区间:-17.63,-6.71)、透明质酸(HA)(MD=-94.89,95%可信区间:-125.19,-64.60)、层粘连蛋白(LN)(MD=-40.08,95%可信区间:-52.38,-27.78)、Ⅳ型胶原(IV-C)(MD=-50.61,95%可信区间:-63.40,-37.81)、Ⅲ型前胶原(PC-III)(MD=-49.71,95%可信区间:-71.72,-27.69)改善了患者的肝功能。联合治疗组的HBeAg血清学转换率(OR=2.23,95%可信区间:1.70,2.94)、HBV-DNA(OR=2.20,95%可信区间:1.70,2.84)、HBsAg(OR=2.25,95%可信区间:1.24,4.07)、总有效率(OR=4.37,95%可信区间:2.62,7.28)和ALT复常率(OR=3.77,95%可信区间:2.46,5.79)均显著高于对照组。

结论

SNMC联合其他疗法在改善慢性乙型肝炎患者肝功能、肝纤维化及提高血清学转换率方面比单用其他疗法更有效,且未引起严重不良事件。但考虑到纳入研究质量较低,结果应谨慎解读,有待高质量、大规模RCT进一步证实。

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