决耐达隆对心房纤颤患者心血管事件的预防效果

目的:观察决耐达隆对心房纤颤患者心血管事件的预防效果。方法:420例心房纤颤患者,随机分为研究组和对照组各210例,分别接受决耐达隆或安慰剂(维生素C)治疗,主要结局为首次住院或死亡。次要结局是全因性死亡、心原性死亡、心血管事件住院等。结果:随访时间为(21±5)月,因心血管事件而提前中止决耐达隆者23例(11%),安慰剂中止者为28例(13%)。主要结局研究组为54例(26%),对照组为68例(32%),危险比为0.76(95%CI,0.69～0.84;P<0.001)。研究组死亡11例(5%),对照组死亡15例(7%),危险比为0.84(95%CI,0.66~1.08;P=0.18)。死于心血管事件者研究组7例(3%),对照组11例(5%),危险比为0.71(95%CI,0.51～0.98;P=0.03),研究组心动过缓、QT-间隔延长、恶心、腹泻、皮疹、血清肌酐水平增加发生率高于对照组。甲状腺和肺相关不良反应事件发生率两组间无差异。结论:决耐达隆可降低心房纤颤患者心血管事件住院率或死亡率。

The Effect of Dronedarone on Prevention of Cardiovascular Events in Patients with Atrial Fibrillation

Objective:To study of the effect of dronedarone on prevention of cardiovascular events in patients with atrial fibrillation.Methods:420patients with atrial fibrillation were assigned to receive dronedarone,400 mg twice a day,or placebo(Vitamin C).The primary outcome was the first hospitalization due to cardiovascular events or death.Secondary outcomes were death from any cause,death from cardiovascular causes,and hospitalization due to cardiovascular events.Results:Follow-up times were(21±5) months,drug discontinued prematurely in 23 cases(11%) receiving dronedarone due to cardiovascular events and in 28 cases(13%) receiving vitamin C.The primary outcome occurred in 54 patients(26%) in the dronedarone group and in 68 patients(32%) in the vitaminC group,with a hazard ratio was 0.76(95% CI,0.69~0.84;P<0.001).The were 11 patients deaths(5%) in study group and 15(7%)patients in control group,with the hazard ratio was 0.84(95% CI,0.66~1.08;P=0.18).The dronedarone group had higher rates of bradycardia,QT-interval prolongation,nausea,diarrhea,rash,and an increased serum creatinine level than the vitaminC group.Rates of thyroid-and pulmonary-related adverse events were not significantly different between the two groups.Conclusion:Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.