维纳卡兰转复心房颤动有效性及安全性的系统评价

Effectiveness and safety of vernakalant in converting atrial fibrillation

目的：系统评价维纳卡兰转复心房颤动（房颤）的有效性及安全性。方法检索PubMed、Cochrane Library、中国生物医学文献数据库，收集2000年1月至2013年6月公开发表的关于维纳卡兰治疗房颤[或心房扑动（房扑）]的前瞻性对照研究。按照预先设定的纳入和排除标准选择文献，采用Jadad评分量表对纳入的文献进行质量评价。由两位研究者独立提取纳入文献的资料，使用Revman5.0统计软件进行Meta分析。结果有7篇前瞻性临床研究满足纳入标准。总共1133例房颤（房扑）患者纳入研究（其中维纳卡兰组668例，对照组465例）。Meta分析显示：维纳卡兰组房颤转复率明显高于对照组（38.3%vs.14.1%；OR=5.73；P＜0.0001），尤其是在新发房颤患者当中其转复率可达52.2%（95%CI：46.9%～57.4%），中位转复时间为11 min。对于持续房颤维纳卡兰的转复率为8.3%（95%CI：3.1%～13.6%）。房扑终止率为2.6%。尽管维纳卡兰延长QRS波时限和QT间期，但在观察期内未增加主要不良心血管事件风险。结论现有循证医学证据显示维纳卡兰可以安全、有效、快速地转复新发房颤，维纳卡兰对房扑转复效果不显著。

Objective To review systematically the effectiveness and safety of vernakalant in converting atrial fibrillation （AF）. Methods The databases of PubMed, Cochrane Library and CBM were retrieved for collecting perspective control studies about treatment of AF （or atrial flutter） were retrieved from Jan. 2000 to Jun. 2013. The studies were selected according to pre-set inclusion and exclusion criteria and then given quality reviews by using Jadad rating scale. The data was extracted by two independent researches from included studies and then given Meta-analysis by using Revman5.0 software. Results There were 7 trials met the inclusion criterion involving 1133 patients （668 in vernakalant group and 465 in control group）. The results of Meta-analysis showed that conversion rate was higher in vernakalant group than that in control group （38.3% vs. 14.1%; OR=5.73; P〈0.0001）. The conversion rate reached 52.2%（95%CI：46.9%~57.4%） in the patients with new-onset AF and median conversion time was 11 min. The conversion rate was 8.3% （95%CI： 3.1%-13.6%） in the patients with persistent AF. Vernakalant had not significant effect on atrial flutter and the terminating rate was 2.6%only. Although it prolonged QRS duration and QT interval, vernakalant did not increase the risk of major cardiovascular adverse events during observation period. Conclusion The current evidence of evidence-based medicine shows that vernakalant is safe, effective and quick in converting AF.