稳心颗粒抗心律失常的Meta分析

A meta analysis on effect of Wen Xin Ke Li in treatment of arrhythmia

目的评价稳心颗粒治疗心律失常的有效性及安全性。方法计算机检索至2010年12月Co-chrane图书馆临床对照试验资料库(CCRCT)、Pubmed、Embase、万方数据库、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBMdisc)、维普数据库(VIP),收集稳心颗粒治疗心律失常的随机对照试验(RCT),按纳入和排除标准由2名评价者独立选择试验、提取资料,交叉核对并进行方法学质量评估,使用RevMan5.0软件进行Meta分析。结果共纳入24项研究的2564例患者。①稳心颗粒抗心律失常疗效优于美西律(OR=2.46;95CI:1.49～4.07;P<0.01)、普罗帕酮(OR=1.98;95CI:1.53～2.58;P<0.01);与胺碘酮无显著性差异(OR=1.34;95CI:0.81～2.23;P=0.26);总体抗心律失常疗效优于西药对照组(OR=1.93;95CI:1.57～2.38;P<0.01)。②心电图改善方面优于美西律(OR=2.24:95CI:1.08～4.65;P<0.05)、普罗帕酮(OR=2.05;95CI:1.56～2.70;P<0.01);与胺碘酮无显著性差异(OR=1.13;95CI:0.52～2.45;P>0.05),总体心电图改善优于西药对照组(OR=1.95;95CI:1.53～2.49;P<0.01)。③安全性方面:致胃肠道不良反应率低于普罗帕酮(OR=0.24;95CI:0.12～0.45;P<0.01);与胺碘酮无显著性差异(OR=0.58;95CI:0.28～1.22;P>0.05);总体致胃肠道不良反应率低于西药对照组(OR=0.34;95CI:0.21～0.54;P<0.01)。稳心颗粒致心律失常不良反应率低于普罗帕酮(OR=0.15;95CI:0.05～0.47;P<0.01);低于胺碘酮(OR=0.06;95CI:0.01～0.24;P<0.01),总体致心律失常不良反应发生率低于西药对照组(OR=0.10;95CI:0.04～0.23;P<0.01)。结论稳心颗粒抗心律失常方面不差于目前临床常用的西药,且不良反应发生率较低。受纳入文献质量的限制,其抗心律失常疗效与安全性的评价期待更多高质量的随机对照双盲试验,以做进一步评价。

Objective To review the effectiveness and safety of Wen Xin Ke Li in the treatment of arrhythmia.Methods The data of randomized controlled trials（RCT） of Wen Xin Ke Li for treating arrhythmia were retrieved with computer from Cochrane Library,PubMed,Embase,Wanfang,CNKI,CBMdisc and VIP until Dec.2010,chosen and extracted by 2 reviewers independently according to inclusion and exclusion criteria,and cross-checked and assessed in the quality and methodology.All data were given Meta analysis by using RevMan 5.0 software.Results There were totally 24 trials and 2564 patients included.①In the aspect of effect of anti-arrhythmia：Wen Xin Ke Li was better than mexiletine（OR=2.46;95% CI：1.49～4.07;P0.01） and propafenone（OR=1.98;95% CI：1.53～2.58;P0.01）,but was not different significantly with amiodarone（OR=1.34;95% CI：0.81～2.23;P=0.26）.The total curative effect on arrhythmia was better in the treatment group than that in the control group（OR=1.93;95% CI：1.57～2.38;P0.01）.②In the improvement of ECG：Wen Xin Ke Li was better than mexiletine（OR=2.24;95% CI：1.08～4.65;P0.05） and propafenone（OR=2.05;95% CI：1.56～2.70;P0.01）,but was not different significantly with amiodarone（OR=1.13;95% CI：0.52～2.45;P0.05）.The total effect of improving ECG was better in the treatment group than that in the control group（OR=1.95;95% CI：1.53～2.49;P0.01）.③In the aspect of safety：the rate of gastric adverse reactions causing by Wen Xin Ke Li was lower than that causing by propafenone（OR=0.24;95% CI：0.12～0.45;P0.01） and was not different significantly with amiodarone（OR=0.58;95% CI：0.28～1.22;P0.05）.The total rate of gastric adverse reactions was lower in the treatment group than that in the control group（OR=0.34;95% CI：0.21～0.54;P0.01）.The rate of arrhythmia adverse reaction causing by Wen Xin Ke Li was lower than that causing by propafenone（OR=0.15;95% CI：0.05～0.47;P0.01） and amiodarone（OR=0.06;95% CI：0.01～0.24;P0.01）.The total rate of arrhythmia adverse reaction was lower that in the Western medicinal group（OR=0.10;95% CI：0.04～0.23;P0.01）.Conclusion The effect of Wen Xin Ke Li in anti-arrhythmia is not worse than the Western medicinal used commonly in clinic now,and the incidence of adverse reactions is lower.The study was limited by the quality of inclusion literature,so more RCT with higher quality are demanded to review further the curative effect and safety of Wen Xin Ke Li.