稳心颗粒治疗心房颤动临床研究的系统评价

The Clinical Study of Wenxin Keli in the Treatment of Atrial Fibrillation: a Systematic Review

目的:对稳心颗粒治疗心房颤动(房颤)的有效性及安全性进行全面系统的评价。方法:电子检索PubMed、Web of Science、Cochrane Library等外文数据库及中国知识基础设施工程(CNKI)、万方数据知识服务平台(Wan Fang Data)、维普期刊资源整合服务平台(VIP)、中国生物医学文献服务系统(SinoMed)等中文数据库,时间截至2018年10月1日。按照Cochrane手册推荐的质量评价标准对纳入研究进行质量学评价,采用Rev Man 5.3软件进行数据分析,采用Stata 14软件Begg检验进行发表偏倚分析。结果:共纳入24篇随机对照试验(RCTs),涉及到2246名房颤患者。结果显示,稳心颗粒单用或者联合西药治疗在控制快速心室率(MD=-7.14,95%CI:-8.42--5.87),降低房颤发作次数和持续时间,缩短窦律转复时间(MD=-3.04,95%CI:-3.47--2.61),增加窦律转复率(RR=1.19,95%CI:1.09-1.29),减少房颤复发率(RR=0.28,95%CI:0.13-0.59),提高左室射血分数(LVEF)(MD=3.44,95%CI:0.87-6.01),改善左心室舒张末内径(LVEDD)(MD=-2.47,95%CI:-2.86--2.08),降低左心房内径(LAd)(MD=-0.91,95%CI:-1.58--0.25),减少P波离散度(Pd)(MD=-4.04,95%CI:-4.15--3.93)等方面效果优于空白对照、安慰剂或单用西药治疗。稳心颗粒联合小剂量胺碘酮在改善P波最大时限(Pmax)优于单用常规剂量胺碘酮治疗(MD=-8.25,95%CI:-10.33--6.17),而稳心颗粒联合常规剂量胺碘酮治疗效果更优(MD=-13.10,95%CI:-13.65--12.55)。与对照组相比,联合治疗组不良反应发生更少,且Begg检验未发现发表偏倚。结论:稳心颗粒单用或者联合西药在房颤治疗中有良好疗效,但仍需要高质量证据予以验证。

Objective: To conduct a comprehensive and systematic review of the efficacy and safety of Wenxin Keli(WXKL) in the treatment of atrial fibrillation(AF). Methods: Seven databases(PubMed, The Cochrane Library, Web ofScience, CNKI, Wanfang Database, VIP and SinoMed) were searched to identify relevant randomized controlled trials(RCTs) from inceptions to 1 October, 2018. Two review authors independently assessed the methodological quality andanalyzed data by Cochrane handbook and the Rev Man 5.3 software. Begg.s test was conducted to assess publication biasvia Stata 14 software. Results: Twenty-four RCTs with 2246 patients were included in this review. Compared with blankcontrol, placebo or western medicine alone, WXKL alone or combined with western medicine could effectively reducerapid ventricular rate(MD=-7.14, 95%CI:-8.42--5.87), the frequency and duration of AF. It could also shorten thesinus rhythm conversion time(MD=-3.04, 95%CI:-3.47--2.61), increase the sinus rhythm conversion rate(RR=1.19,95% CI: 1.09~1.29) and decrease recurrence rate of AF(RR=0.28, 95% CI: 0.13-0.59). Besides, WXKL alone orcombined with western medicine was beneficial for improving the left ventricular ejection fraction(LVEF)(MD=3.44,95% CI: 0.87-6.01), left ventricular end diastolic diameter(LVEDD)(MD=-2.47, 95% CI:-2.86--2.08), left atrialdiameter(LAd)(MD=-0.91, 95%CI:-1.58--0.25) and P wave dispersion(Pd)(MD=-4.04, 95%CI:-4.15--3.93).WXKL combined with low-dose amiodarone was superior to conventional-dose amiodarone alone in improving themaximum P wave(Pmax)(MD=-8.25, 95% CI:-10.33--6.17), and WXKL combined with conventional-doseamiodarone is more effective(MD=-13.10, 95%CI:-13.65--12.55). Compared with the control group, the treatmentgroup had fewer adverse reactions, and the Begg.s test did not find any publication bias. Conclusion: WXKL alone orcombined with western medicine exhibited better therapeutic effects in the treatment of AF, but these results still needhigh-quality evidence to verify.