稳心颗粒治疗心律失常有效性与安全性的Meta分析(1)
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[摘要] 目的 评价稳心颗粒治疗心律失常的有效性与安全性。 方法 利用计算机对文献进行检索，纳入稳心颗粒治疗心律失常随机对照实验文献，数据由两名评价员分别独立提取纳入的文献，并对文献质量进行评价，使用Cochrane协作网提供的ReMan5.0软件对纳入文献进行统计分析，评价不良反应。 结果 10项研究临床有效率结果显示：Chi2=11.59，df=9，P = 0.24>0.05，I2=22%，具有较好的同质性，采用固定效应模型分析，其OR(fixed)=2.09，95%CI[1.45，3.01]，P < 0.000 01。治疗组不良反应为20例，对照组为62例。 结论 综合分析表明稳心颗粒是治疗心律失常的安全有效的药物。
[关键词] 稳心颗粒；心律失常；Meta分析
[中图分类号] R541.5 [文献标识码] A [文章编号] 1673-7210(2012)02(b)-0065-03
Meta-analysis of efficacy and safety of Wenxin Granules in the treatment of arrhythmia
SHI Hua PENG Wei
Jingzhou First People's Hospital, Hubei Province, Jingzhou 434000, China
[Abstract] Objective To evaluate the efficacy and safety of Wenxin Granules in the treatment of arrhythmia. Methods Literature of randomized controlled trials investing arrhythmia treatment with Wenxin Granules were searched and selected with computer. Data from the literature were collected from the literature by two reviewers independently and the qualities of the literature were also assessed. The included literature was analyzed using ReMan5.0 software provided by the Cochrane Collaboration website and adverse events were also assessed. Results 10 studies of clinical efficacy showed: Chi2 = 11.59, df = 9, P = 0.24>0.05, I2 = 22% and homogeneity was good. When the studies were analyzed using a fixed effects model, the OR (fixed) was 2.09 (95%CI [1.45, 3.01], P < 0.000 01). The overall adverse events were 20 cases in the treatment group and 62 cases in the control group. Conclusion The comprehensive analysis shows that Wenxin Granules is a safe and effective drug for arrhythmia.
[Key words] Wenxin Granules; Arrhythmia; Meta-analysis
稳心颗粒是我国批准生产的第一个治疗心律失常的中药新药制剂，已广泛应用于临床，本文试图用Meta分析来评价稳心颗粒治疗心律失常有效性与安全性，为临床医生及患者提供参考。
1 资料与方法
1.1 文献收集
采用“稳心颗粒”为关键词，在《中国期刊全文数据库(CNKI，1994-2010)》，《中文科技期刊全文数据库(VIP，2005-202010》进行检索，收集有关稳心颗粒治疗心律失常的疗效和不良反应的随机对照试验文献。
1.2 纳入标准
①试验采用随机对照，即文中提到“随机”便可纳入；②有治疗组和对照组的观察例数、显效(或治愈)例数、有效例数、无效例数等数据；③有相应的心律失常诊断标准；④治疗组干预措施为稳心颗粒，以其他药物为阳性对照；⑤论文中一般资料齐全，对药物的疗效评定有相应标准，药物的疗效以量化性质反映出来。
1.3 剔除标准
①对重复报告文献只选择发表日期最近的1篇；②质量差、信息不全的文献；③治疗组干预措施除稳心颗粒外还实施了对照组未使用的其他治疗方法；④对照组中无与稳心颗粒相对应的干预措施；⑤文献未设对照组。
1.4 文献的提取及质量评估
根据Cochrane系统评价手册5 ......
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