标题：决奈达隆治疗房颤、房扑有效性与安全性的Meta分析

      作者：郭宗文，王丹丹，王徐乐，黄从新
    (武汉大学人民医院心内科，湖北 武汉 430060)

      卷次： 2014年25卷16期

      【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9 377例患者。Meta分析结果显示：
①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<0.000 01]和心室率
[MD=-12.25，95%CI (-17.09，-7.40)，P<0.000 01]；②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；③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。

      【关键词】 决奈达隆；心房颤动；心房扑动；Meta分析；随机对照试验

      【中图分类号】 R541.7+5 【文献标识码】 A 【文章编号】 1003—6350（2014）16—2458—06


Effectiveness and safety of dronedarone in treating Atrial fibrillation and atrial flutter: a meta-analysis.
GUO
Zong-wen, WANG Dan-dan, WANG Xu-le, HUANG Cong-xin. Department of Cardiology, Renmin Hospital of Wuhan
University, Wuhan 430060, Hubei, CHINA

【Abstract】 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.

      【Key words】 Dronedarone; Atrial fibrillation; Atrial flutter; Meta-analysis; Randomized controlled trial
基金项目：国家科技支撑项目课题(编号：2011BAI11B2)