通脉养心丸治疗心律失常疗效的系统评价与Meta分析

目的系统评价通脉养心丸治疗心律失常的效果。方法系统检索Cochrane图书馆,PubMed,EMBASE,CNKI,VIP,万方数据库等6个电子数据库,检索日期截止至2018年3月,纳入通脉养心丸单用或联合西药治疗心律失常的随机对照试验,提取文献有效数据,并根据Cochrane系统评价方法,应用RevMan 5.3软件进行系统评价和Meta分析。结局指标包括临床疗效,中医证候疗效,24 h心律失常事件次数,中医证候积分和不良反应。结果纳入12项随机对照试验共计1217例患者,通脉养心丸组临床疗效更好(n=1100,RR=1.22,95%CI1.13,1.31],P<0.00001),通脉养心丸组中医证候疗效更好(n=452,RR=1.54,95%CI1.22,1.95],P=0.0003);在控制24 h室性早搏次数方面,两组差异无统计学意义(n=419,MD=-269.27,95%CI-595.01,56.47],P=0.11),亚组分析显示通脉养心丸联合美托洛尔在控制室性早搏心律失常事件数方面优于单纯西药治疗,差异有统计学意义(n=270,MD=-591.51,95%CI-635.46,-547.56],P<0.00001);减轻中医证候积分方面,通脉养心丸组优于单纯西药治疗(n=512,Std.MD=-1.15,95%CI-1.82,-0.47],P=0.0008);不良反应方面,通脉养心丸组与对照组比较无显著差异(n=821,RR=0.93,95%CI0.59,1.47],P=0.77)。结论通脉养心丸治疗心律失常疗效优于单纯西药治疗,无显著不良反应,但需要更多严谨、规范的临床试验来验证。

Tongmai Yangxin Pill for the treatment of arrhythmia:a systematic review and Meta-analysis

Objective To systematically evaluate the effect of Tongmai Yangxin Pill on arrhythmia.Methods Six electronic databases,such as Cochrane Library,PubMed,EMBASE,CNKI,VIP,and Wanfang Database,were searched.The search date was as of March 2018,and the randomization clinical trials of Tongmai Yangxin Pill alone or in combination with western medicine for arrhythmia was included.extracting valid data from the literature,and using Revman5.3 software for systematic and meta-analysis based on the Cochrane systematic review method.Outcome indicators included clinical efficacy,TCM syndrome efficacy,24-hour arrhythmia events,TCM syndrome scores and adverse reactions.Results A total of 1217 patients were enrolled in 12 randomized controlled trials.The Tongmai Yangxin Pill group had better clinical efficacy(n=1100,RR=1.22,95%CI1.13,1.31],P<0.00001).The efficacy of TCM syndrome in the pill group was better(n=452,RR=1.54,95%CI1.22,1.95],P=0.0003).There was no significant difference between the two groups in controlling the 24-hour ventricular premature beats.(n=419,WMD=-269.27,95%CI-595.01,56.47],P=0.11),subgroup analysis showed that Tongmai Yangxin Pill combined with metoprolol was superior in the control of arrhythmia events of ventricular premature beat than western medicine treatment,the difference was statistically significant(n=270,MD=-591.51,95%CI-635.46,-547.56],P<0.00001);Tongmai Yangxin Pill group is better than simple Western medicine treatmentthe in the reduction of TCM syndrome scores,(n=512,Std.MD=-1.15,95%CI-1.82,-0.47],P=0.0008);there was no significant difference between Tongmai Yangxin Pill group and control group in terms of adverse reactions,(n=821,RR=0.93,95%CI0.59,1.47],P=0.77).Conclusion Tongmai Yangxin Pill is better than western medicine in the treatment of arrhythmia.There is no significant adverse reaction,but more rigorous and standardized clinical trials are needed to verify.