伊布利特与胺碘酮转复冠状动脉旁路移植术后新发房颤的安全性与效能比较

Ibutilide and amiodarone in management of new-onset atrial fibrillation after coronary artery bypass grafting:a comparison of safety and efficacy

目的比较伊布利特与胺碘酮在转复冠状动脉旁路移植术后新发房颤中的安全性与效能。方法本研究是一项前瞻性随机单盲的临床试验,共纳入100名满足入选标准的患者,根据随机化原则分别静脉给予伊布利特(组A)或胺碘酮(组B)。给药方法如下:对于组A患者,10min内给予伊布利特1mg,若成功转复则不再给药,若未能转复则10min后重复给药一次,无论转复与否,均不再给药。对于组B患者,首先在30min内,按5mg/kg的剂量给予负荷量,在接下来的24h内以1200mg维持给药,无论转复与否,24h后均不再给药。试验的第一终点是房颤的即时转复率和转复时间效应,第二终点是术后30d的房颤复发率。结果试验期间,两组均未发生严重不良反应。组A的房颤即时转复率高于组B(82%vs58%,P<0.01),而转复时间短于组B(66 min vs 660 min,P<0.01)。两组之间术后30d的房颤复发率没有统计学差异(7.3%vs6.9%,P>0.05)。结论伊布利特和胺碘酮均可安全应用于转复冠状动脉旁路移植术后的新发房颤,相比较而言,伊布利特效果更好,速度更快,效能更高。

Objective To compare the safety and efficacy of ibutilide and amiodarone in converting post-coronary artery bypass grafting（CABG） new-onset atrial fibrillation（AF） to sinus rhythm.Methods This study was a prospective,single blinded,randomized clinical trial.Totally 100 patients who met the inclusion criteria were enrolled and were intravenously treated with ibutilide（group A） or amiodarone（group B）.In group A,Ibutilide was administered at a dose of 1 mg in 10 min,which was repeated after an interval of another 10 min if the arrhythmia was not converted;ibutilide was not given anymore no matter the conversion was achieved or not.In group B,amiodarone was administered at a dose of 5 mg/kg for the first 30 min,followed by 1 200 mg in the next 24 h;amiodarone was not given anymore no matter the conversion was achieved or not.Immediate conversion rate,conversion time and post-operative recurrence rate within 30 days were compared between the two groups.Results No severe adverse reactions were observed in both groups.The immediate conversion rate of group A was significantly higher than that of group B（82% vs 58%,P 〈 0.01）,and the conversion time was significantly shorter than that of group B（66 min vs 660 min,P 〈 0.01）.The post-operative recurrence rates were not significantly different between the two groups within 30 days after operation（7.3% vs 6.9%,P 〉 0.05）.Conclusion Ibutilide and amiodarone are both safe in converting post-CABG new-onset AF to sinus rhythm,and ibutilide is more effective,more rapid in functioning and with a higher efficacy.