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肝爽颗粒治疗乙型肝炎肝硬化有效性与安全性的系统评价

Effectiveness and safety of Ganshuang granules in treatment of hepatitis B cirrhosis:a systematic analysis

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【作者】 康玮玮卢颖陈煜

【Author】 Kang Weiwei;Lu Ying;Chen Yu;Center of Artificial Liver,Beijing YouAn Hospital,Capital Medical University;School of Management,Beijing University of Chinese Medicine;

【机构】 首都医科大学附属北京佑安医院人工肝中心北京中医药大学管理学院

【摘要】 目的 评价肝爽颗粒治疗乙型肝炎肝硬化的有效性与安全性。方法 检索中国知网、万方数据库、维普数据库、美国国立医学图书馆、Springer电子数据库、ProQuest学位论文全文数据库,收集2002年1月1日至2016年9月20日收录的关于肝爽颗粒治疗乙型肝炎肝硬化的随机对照试验。根据纳入及排除标准进行资料提取,综合运用定性与定量评价。结果 共纳入8篇符合要求的文献,改良版Jadad评分1~2分。3篇文献定量分析结果显示,观察组(肝爽颗粒+恩替卡韦)治疗后丙氨酸转氨酶和总胆红素改善情况优于对照组(单用恩替卡韦)(标准化均数差=-1.56、-1.08,95%置信区间:-2.31~-0.80、-1.54~-0.61,均P<0.01)。5篇文献定性分析结果显示,多数研究对肝爽颗粒的临床效果予以肯定,观察组(肝爽颗粒或肝爽颗粒+对照组疗法)的疗效、肝功能指标、肝纤维化指标、肝硬度值改善情况优于对照组(P<0.05);亦有1篇文献显示肝爽颗粒治疗后肝功能指标与对照组比较差异无统计学意义(P>0.05)。1篇文献报道肝爽颗粒治疗乙型肝炎肝硬化无不良反应发生;1篇文献报道观察组(肝爽颗粒+阿德福韦酯)的不良反应发生率明显低于对照组(单用阿德福韦酯)(P<0.05)。结论 肝爽颗粒治疗乙型肝炎肝硬化有一定的临床效果,安全性较好。

【Abstract】 Objective To evaluate the effectiveness and safety of Ganshuang granules in the treatment of hepatitis B cirrhosis. Methods Randomized controlled trials of Ganshuang granules treating hepatitis B cirrhosis were searched in China National Knowledge Internet( CNKI), Wanfang, VIP, the US National Library of Medicine, Springer, ProQuest Dissertations and Theses Full Text( January 1st, 2002 to September 20 th,2016). Literatures were screened based on inclusion and exclusion criteria; corresponding clinical outcomes were analyzed. Results Eight literatures were included; 1-2 points of modified Jadad Scale. Quantitative analysis of 3 literatures showed that improvements of serum alanine aminotransferase and total bilirubin after treatment in observation group( Ganshuang granules + entecavir) were significantly better than those in control group(entecavir)(standardized mean difference =-1. 56,-1. 08; 95% confidence interval: -2. 31 to-0.80,-1. 54 to-0. 61; P <0. 01). Qualitative analysis of 5 literatures showed that the curative effect and improvements of liver function indexes, hepatic fibrosis indexes and liver hardness in observation group( Ganshuang granules or Ganshuang granules + control group therapy) were significantly better than those in control group(P < 0. 05); 1 literature reported that liver function indexes in observation group had no significant improvement compared to those in control group( P >0. 05). Two literatures reported adverse reactions; 1 of them observed no adverse effect; 1 literature showed that the adverse reaction rate in observation group( Ganshuang granules +adefovir) was significantly lower than that in control group( adefovir)(P <0. 05). Conclusion Ganshuang granules are safe and effective in treatment of hepatitis B cirrhosis.

  • 【分类号】R259
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