中国药物警戒 ›› 2013, Vol. 10 ›› Issue (3): 136-139.

• 基础及临床研究 • 上一篇    下一篇

胺碘酮注射液对住院患者QTc间期的影响程度及安全性评价

张晓星1,张黎明2, 郑青敏3, 纪立伟4,丁庆明5,刘玉清1,娄莹1,李一石1   

  1. 1.北京协和医学院,中国医学科学院,阜外心血管病医院,卫生部心血管药物临床研究重点实验室,北京100037；
    2.北京市药品不良反应监测中心,北京100024；
    3.首都医科大学附属北京安贞医院,北京100029；
    4.卫生部北京医院,北京100005；5卫生部中日友好医院,北京100029
  • 收稿日期:2013-01-21 修回日期:2016-03-09 出版日期:2013-03-08 发布日期:2016-03-09
  • 通讯作者: 李一石,女,教授,博士生导师,心血管临床药理研究。 E-mail：liyishi@public3.bta.net.cn
  • 作者简介:张晓星,男,主治医师,博士研究生,心内科与心血管药物临床评价。
  • 基金资助:
    “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》。

Impact on QTc Interval and Safety Evaluation of Amiodarone Injection for Inpatients

ZHANG Xiao -xing1, ZHANG Li -ming2 ,ZHENG Qing -min3, JI Li-wei4 ,DING Qing -ming5, LIU Yu -qing1 ,LOU Ying1 ,LI Yi-shi1   

  1. 1.Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Ministry of Health, Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC, Beijing 100037, China;
    2.Beijing Center for ADR Monitoring, Beijing 100024, China;
    3.Beijing An Zhen Hospital of the Capital University of Medical Sciences, Beijing 100029, China;
    4.Beijing Hospital of the Ministry of Health, Beijing 100005, China;
    5China-Japan Friendship Hospital of the Ministry of Health, Beijing 100029, China
  • Received:2013-01-21 Revised:2016-03-09 Online:2013-03-08 Published:2016-03-09

PDF (PC)

179

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 vs 99.6±27.9bpm, P<0.001）,QT 间期较药前延长（388.5±55.9ms vs 366.0±55.9ms,P <0.001）,但QTc间期无显著变化（456.8±51.0ms vs 457.8±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。

关键词: 胺碘酮注射液, QTc间期, 药品不良反应, 尖端扭转型室性心动过速

Abstract: Objective To evaluate the impact on QTc interval and relevant adverse drug reaction of amiodarone injeon 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, <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. Conclusion 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.

Key words: amiodarone injection, QTc interval, adverse drug reaction(ADR), TdP

中图分类号: