稳心颗粒联合美托洛尔治疗心房颤动有效性和安全性的Meta分析

Effect of Wenxin Granule combined metoprolol on atrial fibrillation： a meta-analysis

目的 评价稳心颗粒联合美托洛尔治疗心房颤动的有效性与安全性.方法 计算机检索Cochrane图书馆临床对照试验资料库（2013年第12期）、PubMed（建库至2013年）、EMbase（建库至2013年）和万方数据库（建库至2013年）、维普中文科技期刊数据库（建库至2013年）、中国知网（建库至2013年）、中国生物医学文献服务系统（CBM）（建库至2013年）.收集稳心颗粒联合美托洛尔治疗心房颤动的临床随机对照试验.按照纳入和排除标准,由3名研究者独立筛选试验;提取资料（包括纳入研究的样本量、患者基本信息、干预措施、疗程、临床疗效及不良反应等）,并采用Cochrane协助网推荐的偏倚风险评估方法评估所纳入研究的方法学质量然后交叉核对.使用Cochrane协助网提供的RevMan 5.1软件进行Meta分析.结果 共纳入11个随机对照试验.纳入研究的方法学质量均偏低.共纳入805例患者,其中治疗组（稳心颗粒联合美托洛尔组）患者422例,对照组（单用美托洛尔组）患者383例.治疗组中同时改善心房颤动症状、发作情况者239例,对照组165例.治疗组中发生不良反应者25例.对照组中发生不良反应者23例.Meta分析结果显示在治疗心房颤动疗效方面,治疗组优于对照组：在改善心悸、胸闷、气短等症状[相对危险度（RR）=1.34,95％置信区间（CI）：1.17 ～ 1.54],减少心房颤动发作次数及心率控制（RR=1.31,95％ CI：1.15 ～ 1.48）以及同时具有上述2种作用方面（RR=1.23,95％ CI：1.14 ～ 1.34）,2组差异有统计学意义（均P ＜0.05）;在不良反应发生率方面（RR=1.00,95％ CI：0.59 ～ 1.69）,2组差异无统计学意义（P＞0.05）.结论 稳心颗粒联合美托洛尔治疗心房颤动在改善患者症状和减少心房颤动发作方面均优于单用美托洛尔.尚不能认为2组不良反应发生率有差别.但由于本研究所纳研究样本量小,方法学质量偏低,存在偏倚风险,有必要开展设计合理、大样本量、多中心的临床随机对照试验进一步验证上述结论的可靠性.

Objective To evaluate the efficacy and safety of Wenxin Granule and metoprolol for atrial fibrillation.Methods We searched The Cochrane Library（2013 December）,Pubmed（the commencement of the database to 2013）,EMBASE （the commencement of the database to 2013）,China Nation Knowledge infrastructure （the commencement of the database to 2013） and the Wanfang Data base（the commencement of the database to 2013）,Weipu Data base（the commencement of the database to 2013）,CBM （the commencement of the database to 2013）on computers for parallel group randomized controlled trials （RCTs） comparing Wenxin Granule combined metoprolol and metoprolol for patients with atrial fibrallation.Three researchers selected the trials based on the include and exclude criterions and then extracted the data including sample size,basic information of patients,intervening measure,course of treatment,clinical efficacy,adverse effect,and so on.Assessed the quality of each trial using the tool for assessing risk of bias recommended by eochrane collaboration independently.After cross checked,The RevMan 5.1 software provided by the cochrane collaboration was used to perform meta-analysis.Results Eleven RCTs were involved.All trial methodologies are low quality.A total of 805 patients.Four twenty two patients were treated using Wenxin Granule combined metoprolol as the treatment group.383 patients were treated using metoprolol as the control group.There were 265 cases whose symptoms and onset of atrial fibrillation were improved in the treatment group and 185 cases in the control group.25 eases in the treatment group happened adverse effect and 26 cases in the control group.Meta-analysis showed that：Wenxin Granule combined metoprolol had better curative effect on atrial fibrillation than metoprolol：symptom-improvement [relative risk （RR） =1.34,95％ confidenceinterval（CI）：1.17-1.54],reduced the onset of atrial fibrillation （RR =1.31,95％ CI：1.15-1.48）,symptom-improvement also reduce the onset of atrial fibrillation （RR =1.23,95％ CI：1.14-1.34）.But there was not significant difference in adverse effects rate between the two groups （RR =1.00,95％ CI：0.59-1.69,P ＞ 0.05）.Conclusions Compaired to metoprolol,Wenxin Granule combined metoprolol has better curative effect.The adverse effect rate between two groups is not significantly different.But because of little-scale,inferior quality,biase risk of these trials,large-scale,rational design and multicenter RCTS are needed to confirm our conlusions.