中国药物警戒 ›› 2018, Vol. 15 ›› Issue (11): 686-689.

• 安全性评价与合理用药 • 上一篇    下一篇

1101例氢溴酸高乌甲素不良反应分析

刘松东1, 邱健珉1, 王兰兰2, 董芳1, *   

  1. 1 临沂市药品不良反应监测中心,山东 临沂 276000;
    2 临沂市中医医院,山东 临沂 276000
  • 收稿日期:2019-01-09 修回日期:2019-01-09 出版日期:2018-11-20 发布日期:2019-01-09
  • 通讯作者: 董芳,女,本科,主任药师,药品不良反应监测。E-mail：linyiadr@163.com
  • 作者简介:刘松东,男,本科,药师,药品不良反应监测。

Analysis of 1 101 Cases of Adverse Drug Reactions Induced by Lappaconitine Hydrobromide

LIU Songdong1, QIU Jianmin1, WANG Lanlan2, DONG Fang1, *   

  1. 1 Linyi Center for ADR Monitoring, Shandong Linyi 276000, China;
    2 Chinese Medicine Hospital in Linyi City, Shandong Linyi 276000, China
  • Received:2019-01-09 Revised:2019-01-09 Online:2018-11-20 Published:2019-01-09

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摘要： 目的 分析氢溴酸高乌甲素药品不良反应（ADR）的发生情况和临床使用情况,为临床安全合理用药提供参考。方法 检索并整理2004年1月至2018年2月山东省境内发生并上报国家药品不良反应监测系统的数据,并对其进行统计分析。结果 共有 1 101例ADR报告纳入分析,氢溴酸高乌甲素致不良反应主要为皮肤及其附件损害（23.31%）、胃肠损害（17.62%）、神经系统损害（15.85%）、呼吸系统损害（15.68%）等。严重不良反应报告97例,主要表现为胸闷、心悸、呼吸困难、寒战、高热等。此外,疑似存在临床超剂量用药、溶媒不当等现象。结论 氢溴酸高乌甲素说明书的不良反应内容描述过于简单,应进一步补充完善。临床应严格按照说明书的用法用量用药,避免超剂量给药。静脉滴注时,溶媒用量要充足,尽量避光使用。

关键词: 氢溴酸高乌甲素, 不良反应, 临床使用

Abstract: Objective To analyze adverse drug reactions (ADRs) of lappaconitine hydrobromide, and provide reference for clinical rational use. Methods The data of Shandong province from January 2004 to February 2018 on National Adverse Drug Reaction Monitoring System was retrieved and the data was analyzed. Results There are totally 1 101 cases of ADRs included in the analysis. The most common ADRs caused by lappaconitine hydrobromide were skin and appendages disorders(23.31%), gastrointestinal disorders(17.62%), neurological disorders(15.85%) and respiratory disorders(15.68%). 97 cases of severe ADRs were reported, mainly containing chest tightness, palpitations, dyspneas, rigors and hyperpyrexias. Besides, we found overdose and dissolvent mismatch in clinic. Conclusion The labelling of lappaconitine hydrobromide remains to be supplemented and perfected. Clinicians should strictly follow the instructions in terms of usage and dosage. When the lappaconitine hydrobromide was given by infusion, menstruum should be sufficient and away from light.

Key words: lappaconitine hydrobromide, adverse reactions, clinical application

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