决奈达隆治疗房颤、房扑有效性与安全性的Meta分析

摘要

目的：评价决奈达隆治疗心房颤动、心房扑动的疗效及安全性。方法计算机检索PubMed、Embase、the Cochrane Collaboration Database，查找建库至2014年2月28日期间发表的所有关于决奈达隆治疗房颤、房扑的英文随机对照试验(RCT)。由两位研究者按照纳入排除标准进行文献筛选、资料提取和方法学质量评价后，采用RevMan 5.2软件进行Meta分析。结果最终纳入6个RCT，共计9377例患者。Meta分析结果显示：与安慰剂比较，决奈达隆能显著降低房颤、房扑的复发率[OR=0.55，95%CI(0.43,0.72)，P<0.00001]和心室率[MD=-12.25，95%CI (-17.09，-7.40)，P<0.00001]；与安慰剂相比比较，决奈达隆增加了患者的心血管事件住院率[OR=1.17，95%CI(0.43,3.21)，P=0.76]，降低了患者的总死亡率[OR=0.95，95%CI(0.76，1.20)，P=0.67]，但差异均无统计学意义；与安慰剂比较，决奈达隆增加了总的不良反应发生率[OR=1.48，95%CI(1.06,2.05)，P=0.02]，但未显著增加严重不良反应发生率[OR=1.17，95%CI(0.79，1.72)，P=0.43]。结论决奈达隆对于房颤、房扑患者疗效显著且耐受良好，但要慎用于有严重器质性心脏病的永久性房颤患者。由于纳入研究数量及质量有限，需要开展更多高质量随机对照临床试验进一步确认。%Objective To assess the effectiveness and safety of dronedarone in the treatment of atrial fibrilla-tion (AF) and atrial flutter (AFL). Methods All randomized controlled trials (RCTs) examining dronedarone for the treatment of AF and AFL were retrieved from databases, including PubMed, the Cochrane Collaboration Database and Embase, from the database' s initial construction to February 28, 2014. After the quality of included RCTs was assessed, the Cochrane Collaboration's software RevMan 5.2 was used for meta-analysis. Results 6 RCTs involving 9 377 pa-tients were included. Meta analysis showed that, compared with placebo, dronedarone reduced recurrence of atrial fi-brillation and atrial flutter [OR=0.55, 95%CI (0.43, 0.72), P<0.000 01] and ventricular rate during onset of atrial fibril-lation and atrial flutter [MD=-12.25, 95%CI (-17.09,-7.40), P<0.000 01]. Compared with placebo, dronedarone didn't significantly increase the hospitalization rate due to cardiovascular events [OR=1.17, 95%CI (0.43, 3.21), P=0.76] and didn't significantly reduce all-cause mortality [OR=0.95, 95%CI (0.76, 1.20, P=0.67]. Dronedarone was well tolerat-ed. Compared with placebo, dronedarone increased the incidence of all adverse drug reactions [OR=1.48, 95% CI (1.06, 2.05),P=0.02], but didn't significantly increase serious adverse drug reactions [OR=1.17, 95%CI (0.79,1.72), P=0.43]. Conclusion Dronedarone is effective and well-tolerated in treating AL and AFL. Because of the limited quantity and amount of the included studies, this conclusion has to be further proved by more high-quality RCTs.