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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 and evaluate the safety of intravenous injection of ibutilrate fumarate and propafenone injection in patients with atrial fibrillation and atrial flutter. Methods: From February 2004 to October 2005, 200 patients with atrial fibrillation and atrial flutter were enrolled in a randomized, double-blind, controlled clinical study. 200 patients were randomly divided into three groups according to the ratio of 1: 1 Patients in the ibutilide group (1 mg, iv, repeated if necessary; patients weighing less than 60 kg administered at 0.01 mg.kg-1) or propafenone (70 mg, iv, repeated if necessary) Administered 1 time), observation of heart rhythm recovery, monitoring of clinical symptoms, blood pressure, heart rate, electrolyte, liver and kidney function, ECG changes, 24 h Holter. RESULTS: At 90 min after administration, the total revascularization rate was 55% (55/100) in atrial fibrillation or atrial flutter group, and 50% (40/79) in atrial fibrillation group. The rate of atrial flutter was 71% (15/21) in the propofol group, 21% (21/100) in the propafenone group and 24% (21/90) in the atrial fibrillation group. There was no significant difference in RR interval between two groups when resuscitated. One case of torsades de pointes ventricular tachycardia (1%) occurred in the ibutilide group and was successfully converted to sinus rhythm by electrical cardioversion. Conclusion: The effect of intravenous injection of ibutilide on atrial fibrillation is superior to that of propafenone on atrial flutter, which is consistent with the findings from other countries. Arrhythmia and other adverse reactions were no significant difference between the two groups.