摘要
目的评价胺碘酮注射液对住院患者QTc间期的影响程度及相关的药品不良反应。方法研究纳入2011年5月至2012年7月间北京市4家三级甲等医院的住院患者1 111例,观察应用胺碘酮注射液24h内的QTc间期是否与用药前相比存在差异,以及在胺碘酮注射液用药期间是否发生与其相关的致心律失常作用。结果与用药前相比,用药后患者的平均心率较药前减慢(87.4±21.2bpm vs99.6±27.9bpm,P<0.001),QT间期较药前延长(388.5±55.9msvs366.0±55.9ms,P<0.001),但QTc间期无显著变化(456.8±51.0msvs457.8±50.2ms,P=0.554)。1例房性心动过速患者在合并应用胺碘酮口服制剂54h后,QTc间期延长至756ms,并出现尖端扭转型室性心动过速,停用胺碘酮及给予相应治疗后未再发生异位心律失常。结论在24h内应用胺碘酮注射液对住院患者的QTc间期无显著性影响,对于长时间静脉给药,特别是合并应用口服胺碘酮的患者,需对心电图进行监测,警惕药品不良反应的发生。
Objective To evaluate the impact on QTc interval and relevant adverse drug reaction of amiodarone injection for inpatients. Methods 1 111 inpatients from 4 upper first class hospitals in Beijing were enrolled from May 2011 to July 2012, the QTc intervals were measured to evaluate whether there would be change before and after amiodarone injection within 24 hours, and suspected proarrhythmia adverse effects due to study drug were monitored during the entire period of administration. Results The average heart rate was slowed（87.4±21.2bpm vs 99.6±27.9bpm, P 〈0.001） and QT interval was prolonged（388.5±55.9ms vs 366.0±55.9ms, P 〈0.001） significantly after amiodarone administration as compared with the baseline, but QTc interval was not changed with statistical significance（456.8±51.0ms vs 457.8±50.2ms, P =0.554）. One patient with atrial tachycardia experienced TdP after 54 hours amiodarone injection concomitant with oral amiodarone showed a prolonged QTc interval up to 756ms previously, TdP didn＇t occur again after amiodarone discontinuation and appropriate treatment. Con01usion Amiodarone injection within 24 hours does not impact on QTc interval with statistical significance in inpatients. Electrocardiograph should be monitored in a continuous amiodarone injection to avoid the relevant adverse drug reaction, especially when using oral amiodarone concomitantly.
出处
《中国药物警戒》
2013年第3期136-139,共4页
Chinese Journal of Pharmacovigilance
基金
"重大新药创制"科技重大专项-<心血管创新药物临床研究技术平台建设>(2012ZX09303008-001)
国家临床重点专科建设项目-<卫生部重点实验室项目>
