静脉注射伊布利特转复心房颤动、心房扑动的中国多中心随机对照临床研究

Comparison of converting efficacy and safety of intravenous ibutilide and propafenone in Chinese patients with atrial fibrillation and atrial flutter

目的:静脉注射富马酸伊布利特注射液与普罗帕酮注射液对心房颤动、心房扑动患者转复疗效的比较及安全性评价。方法:2004年2月-2005年10月,采用前瞻性随机、双盲、对照临床研究方法,入选200例90 d内发生心房颤动、心房扑动的患者,按1∶1的比例随机分为伊布利特治疗组(1 mg,iv,必要时重复给药1次;体重小于60 kg者按0.01 mg.kg-1给药)或普罗帕酮对照组(70 mg,iv,必要时重复给药1次),观察心律的转复,监测临床症状、血压、心率、电解质、肝肾功能、心电图改变、24 h动态心电图等。结果:给药后90 m in,伊布利特组心房颤动或心房扑动患者总转复率为55%(55/100例),心房颤动转复率为50%(40/79例),心房扑动转复率为71%(15/21例);普罗帕酮组总转复率为21%(21/100例),心房颤动转复率为24%(21/90例)。转复时RR间期两组比较无显著性差异。伊布利特组发生1例尖端扭转型室性心动过速(1%),经电复律成功转为窦性心律。结论:静脉注射伊布利特转复心房颤动、心房扑动疗效优于普罗帕酮,与国外研究结果一致。心律失常等不良反应两组间比较无显著性差异。

Objective： To compare converting efficacies of intravenous ibutilide and propafenone on atrial fibrillation（AF） and artial flutter（AFL） in Chinese patients in a prospective study.Methods： We investigated 200 AF and AFL patients treated with ibutilide（1 mg,or 0.01 mg·kg-1 if body weight 60 kg,iv） or propafenone（70 mg,iv,repeated if necessary） in the randomized and controlled study.A second infusion was performed 10 min later if first infusion failed.Results： Overall,ibutilide had a higher cardioversion rate（55%,55/100） than propafenone（21%,21/100）.Ibutilide converted more patients to sinus rhythm in patients with either AF [50%（40/79） vs 24%（21/90）] or AFL [71%（15/21） vs 0%].The RR intervals were not statistically different between AF and AFL during conversion.One torsade de pointes（TdP,1%） developed in ibutilide group and was converted by direct current electrical conversion.Conclusion： Ibutilide is more effective than propafenone in converting AF or AFL in Chinese patients.Adverse events are not significantly different between ibutilide and propafenone.