富马酸伊布利特与盐酸普罗帕酮治疗心房颤动和扑动的疗效比较

A clinical study of immediate cardioversion of atrial fibrillation and atrial flutter attacking less than 90 days with ibutilide versus propafenone

目的:比较静脉注射富马酸伊布利特与盐酸普罗帕酮治疗持续时间＜90d的房扑/房颤的有效性及安全性。方法:本研究为前瞻性随机单盲对照研究。房扑房颤患者共40例,随机分为试验组(伊布利特组,22例,其中房扑9例,房颤13例)和对照组(普罗帕酮组,18例,其中房扑7例,房颤11例)。两组分别在持续心电、血压监护下于10min内静脉推注伊布利特1mg或普罗帕酮70mg,如给药结束10min后仍未转复为窦性心律,重复前述治疗1次。观察给药后4h内的房扑/房颤的转复率及不良反应的发生情况。结果:40例中19例在90 min内转复,其中盐酸普罗帕酮组5例,转复率27．8%,富马酸伊布利特组14例,转复率63．6%,两组比较差异有统计学意义(P＜0．05)。富马酸伊布利特组22例中有1例(4,4%)发生短阵室速,2例(8．1%)发生频发室早,未行特殊处理自行消失。无严重不良反应。结论:与普罗帕酮比较,富马酸伊布利特对房扑/房颤的转复具有明显的优势。

Objective ： To assess the efficacy and safety of ibutilide versus propafenone in immediate cardioversion of atrial fibrillation （AF） and atrial flutter （AFL） attacking less than 90 days. Methods： A prospective, randomized single blind and comparison controlled clinical study recruited 40 patients who were attacked AF or AFL less than 90 days. The patients were randomized to one of two treatment groups： ibutilide （1 mg, iv, n =22） and propafenone （70 mg, iv, n = 18）.The study drugs were infused within 10 minutes in aids of ECG and blood pressure monitoring. The patients who remained AF/AFL at the end of 10-minute infusion were repeated the infusion procedure of study drugs. The conversion rate within 1.5 hours and adverse effects within 4 hours were recorded. Results ： The ibutilidetreated patients had the AF/AFL conversion rate of 63.6% , compared with the propafenone-treated patients of 27.8% （P 〈 0.05 ）. The patients in ibutilide group experienced an incidence rate of transitory ventricular tachycardia of 4.4% and ventricular premature beat of 8.1%, which disappeared without any treatment. Conclusion： Intravenous administration of ibutilide in cardioversion of AF and AFL is safe and effective.