伊布利特联合胺碘酮治疗心房扑动/心房颤动的疗效观察

Effects of ibutilide and amiodarone on cardioversion in patients with atrial flutter or atrial fibrillation

目的观察伊布利特联合胺碘酮转复心房扑动（房扑）／心房颤动（房颤）的有效性及安全性。方法选择符合条件的患者88例，按制定的入选标准与排除标准将88例患者根据是否服用胺碘酮分为对照组和试验组。对照组：单用伊布利特；试验组：口服胺碘酮后联合伊布利特。口服胺碘酮组负荷量7～15g（3～4周内达到靶剂量）。伊布利特首剂1．0mg，10min内缓慢静脉注射，如给药10min后仍未转复为窦性心律，行第2次注射，剂量仍为1．0mg，观察开始给药后4h内转复的成功率、转复过程中用药剂量、用药前后的QT间期的差异及4h内不良反应的发生情况。结果①试验组房扑转复成功率（92％）高于对照组（56％），但差异无统计学意义（P=0．116）；而房颤转复成功率试验组（76％）与对照组（44％）差异有统计学意义（P=0．010）；试验组（80％）与对照组（47％）房扑和房颤总的转复成功率差异亦有统计学意义（P=0．003）。②在转复房扑、房颤成功的患者伊布利特使用剂量房扑[（1．1±0．4）mg]低于房颤[（1．7±0．4）mg]，差异有统计学意义（P〈0．01）。③试验组与对照组使用伊布利特前QT间期（0．49±0．08）、（0．43±0．04）差异无统计学意义（P=0．760）；2组使用伊布利特后QT间期（0．52±0．06）、（0．45±0．03），差异亦无统计学意义（P=0．150）；试验组与对照组各自在注药前后QT间期均延长，差异有统计学意义（对照组P=-0．013；试验组P〈0．01）。④试验组有2例室性心动过速（发生率为2％）。1例在推药过程中发生尖端扭转型室性心动过速（Trip），经电复律终止，转为窦性心律、频发室性早搏，再次房颤继之再发Tdp，静脉注射2．5g硫酸镁终止；1例在转复成功5min后发生非持续单形性室性心动过速，自行终止。2组各发生2例窦性停搏，均在2-3s后自行或经胸外按压后恢复窦性心律。结论口服胺碘酮联合伊布利特转复房扑，房颤成功率高于单一用药，并可预防其复发，联合应用未增加不良事件的发生率。

Objective To evaluate the efficacy and safety of ibutilide and amiodarone on cardioversion in pa- tients with atrial flutter or atrial fibrillation （AFL/AF）. Methods Eighty-eight patients who met eligibility were ran- domized to receive ibutilide alone （control group） or in combination with amiodarone （experimental group）. Amiodarone was administered orally at an initial dose of 7-15 g, which was subject to up-titration to the targeted dose within 3 to 4 weeks. Ibutilide was administered intravenously, in a slow fashion （within 10 rain）, at an initial dose of 1.0 mg, and if cardioversion failed, a repeated injection may be warranted. This entailed the determination of the rate of successful cardioversion at 4 hours, the dose needed during cardioversion, the difference in the QT interval before and after in- jection and the incidence of adverse events within 4 hours. Results Experimental group yielded a numerically but not statistically higher success cardioversion rate of AFL than control group （92% vs 56%, P=0.116）. However, the success cardioversion rates of AF and AFL plus AF were statistically different （76% vs 44%, P=0.010; 80% vs 47%, P=0.003）. Pateints with AFL were administered with a markedly lower dose of ibutilide for successful cardioversion than those with AF [（1.1±0.4） mg vs （1.7±0.4） mg, P〈0.01）]. There were no notable differences in the QTc prior to （0.49±0.08 vs 0.43±0.04,P=0.760） and after ibutilide injection （0.52±0.06 vs. 0.45±0.03, P=0.150） between the two groups. The extension of QTc before and after ibutilide injection was statistically different （P=0.013 for control group and P〈0.01 for experimental group）. Of the two cases （2%） that developed ventricular tachycardia, one in experimental group elicited torsades de pointes during injection, which was converted to sinus rhythm and recurrent ventricular premature beats following 2.5 g MgSO4 intravenous injection, which again converted a secondary recurrent AF and subsequent torsades de pointes to sinus rhythm. The other case developed non-continuous monomorphous ventricular tachycardia that resolved per se at 5 minutes after successful conversion. Two patients in individual group elicited si- nus arrest which could be restored to sinus rhythm per se or by chest wall compressing after 2 to 3 seconds. Conslusion The successful conversion rate conferred by the addition of amiodarone is higher than that by either medica- tion alone. The combination of ibutilide and amiodarone may be worthwhile for prevention of recurrence of AF/AFL with a non-inferiority in the safety profiles.