利用Meta分析法评价稳心颗粒治疗心律失常的有效性及安全性。通过计算机检索Cochrane图书馆、PubMed数据库、Medline （Ovid） and Medline In-Process & Other-数据库、Embase （Ovid）数据库、中国期刊全文数据库（CNKI）、中文科技期刊全文数据库（维普）和万方数字化期刊全文库，时间截至2013年6月。收集稳心颗粒治疗心律失常的随机对照试验（RCT）文献，按纳入和排除标准由2名评价者独立选择试验、提取资料，交叉核对并进行文献质量评价，最后纳入研究的文献使用RevMan 5.0软件进行Meta分析。共纳入25项研究的2 947例患者。通过本次研究表明，稳心颗粒治疗心律失常在临床疗效方面优于普罗帕酮（OR=2.07，95% CI为1.52～2.83，P<0.000 01）、美托洛尔（OR=3.68，95% CI为2.11～6.41，P<0.000 01）、盐酸美西律（OR=3.16，95% CI为1.75～5.72，P<0.000 1），与胺碘酮相比无显著性差异（OR=1.29，95% CI为0.90～1.85，P=0.16）；在改善心电图方面，稳心颗粒优于普罗帕酮（OR=2.39，95% CI为1.72～3.34，P<0.000 01），与美托洛尔无显著性差异（OR=1.80，95% CI为0.69～4.67，P=0.23）；在安全性方面，稳心颗粒致胃肠道不良反应发生率低于胺碘酮（OR=0.54，95% CI为0.29～0.98，P=0.04）；致心律失常发生率低于胺碘酮（OR=0.05，95% CI为0.02～0.16，P<0.000 01）。稳心颗粒治疗心律失常安全有效，但仍亟需高质量的临床研究进一步验证稳心颗粒治疗心律失常的有效性和安全性。

To evaluate the efficacy and safety of Wenxin Granules (WG) in the treatment of arrhythmia using Meta-analysis. Cochrane library, PubMed database, Medline (Ovid) and MEDLINE In-Process & Other database, Embase (Ovid) Database, CNKI Database, VIP Database, and Wanfang Database were searched until June, 2013. The data of randomized controlled trials (RCT) of WG were chosen and extracted by two reviewers independently according to inclusion and exclusion criteria, and cross-checked and assessed in the quality and methodology. Meta analysis on all the data arecarriee out by using RevMan 5.0 software. There are totally 25 trials and 2947 patients included. In the aspect of the effect of anti-arrhythmia: WG is better than Propafenone (OR = 2.07; 95% CI: 1.52 － 2.83; P <0.000 01), Metoprolol (OR = 3.68; 95% CI: 2.11 － 6.41; P < 0.000 01), Mexiletine hydrochloride (OR = 3.16; 95% CI: 1.75 －5.72; P < 0.000 1), but is not significantly different with Amiodarone (OR = 1.29 , 95% CI: 0.90 － 1.85; P = 0.16); In the improvement of ECG: WG is better than Propafenone (OR = 2.39; 95% CI: 1.72－ 3.34; P <0.000 01）, but is not significantly different with Metoprolol (OR = 1.80; 95% CI: 0.69 － 4.67; P = 0.23); In the aspect of safety: the rate of gastric adverse reactions caused by WG is lower than that caused by Amiodarone (OR = 0.54; 95% CI: 0.29－0.98; P = 0.04); The rate of arrhythmia adverse reaction caused by WG is lower than that caused by amiodarone (OR = 0.05; 95% CI: 0.02 － 0.16; P < 0.000 01). Conclusion WG is effective and safe for arrhythmia, but more clinical study should be done to confirm the effective and safety.

“十二五”国家科技支撑计划课题“安全合理用药评价和干预技术研究与应用”（2013BAI06B04）