伊布利特对短期新发房颤及房扑转复的临床研究

Clinical Study of Ibutilide on the Short-term New Onset Atrial Fibrillation and Flutter

目的：探讨静脉注射伊布利特与普罗帕酮转复持续时间〈72 h的新发的心房颤动（房颤）、心房扑动（房扑）的有效性及安全性。方法：筛选18-75岁,持续时间≤72 h（1-72 h）、心室率≥60次/min首次发作的房颤/房扑患者共41例,完全随机化方法分为A组（伊布利特）20例和B组（普罗帕酮）21例。A组中体重≥60 kg的患者首次剂量1 mg,体重〈60 kg的患者首剂0.01 mg/kg,若无效果10 min后再次给予1 mg或按0.01 mg/kg泵入。B组患者首次剂量70 mg,若无效果10 min后再给予35 mg。结果：两组均能有效降低房颤/房扑的心室率,但组间比较差异无统计学意义（P〉0.05）。A组转复率65.0%,B组33.3%,两组比较差异有统计学意义（P〈0.05）。B组中转复失败的病例中有8例改用伊布利特治疗,其中6例转为窦性心律,而A组转复失败的5例患者改用普罗帕酮后均未能转复。A组转复时间（13.50±9.27）min,显著短于B组（27.32±10.27）min,比较差异有统计学意义（P〈0.05）。A组1例老年患者用药后出现尖端扭转性室性心动过速,经直流电复律后转复为窦性心律;B组2例出现左心衰竭。结论：对于72 h以内新发的房颤/房扑伊布利特疗效高于普罗帕酮,转复时间短于普罗帕酮,两药的不良反应一般无需特殊处理。

Objective： To investigate the efficacy, safety and tolerance of intravenous Ibutilide for conversion of atrial fibrillation（AF） and flutter（AFL） to normal sinus rhythm. Method： 41 consecutive patients aged 18-75 years with the first onset of AF/AFL were included. The duration of arrhythmia was less than 72 hours（ranged from 1 hour to 72 hours）, and ventricular rate（VR） was more than 60 beats/min. All the patients were assigned randomly into group A（Ibutilide, 20 patients） and group B（Propafenone, 21 patients）.Group A received Ibutilide 1 mg if body weight ≥ 60 kg or 0.01 mg/kg if body weight60 kg,treatment was repeated if atrial fibrillation or flutter was not converted after 10 min of the first dosage.Group B received Propafenone 70 mg, followed by Propafenone 35 mg if atrial fibrillation or flutter persisted after 10 min of the first dosage.Result： Both two drugs decreased ventricular rate, but there was no statistically significant difference at group comparison（P〈0.05）. AF/AFL were converted in 13 cases（65.0%） in the group A and 7 cases（33.3%） in the group B,the difference was statistically significant（P〈0.05）. Ibutilide had a significantly faster converting time than Propafenone（13.50±9.27）min vs（27.32±10.27）min,the differences were statistically significant（P〈0.05）. Six of eight patients who were unsuccessful in group B were converted with Ibutilide alternatively, but none of the five patients who were unsuccessful in the group A were converted with Propafenone alternatively.Torsade de pointes occurred in one elderly patient with left ventricular dysfunction in the group A,it converted to sinus rhythm after direct current cardioerter.Other two patients appeared left sided heart failure in the group B. Conclusion： This observation suggests the superior efficacy and faster converting time of Ibutilide are over Propafenone when administered to convert AF/AFL to sinus rhythm. Furthermore,the adverse reactions of the two drugs generally need no special treatment.