中国药物警戒 ›› 2010, Vol. 7 ›› Issue (7): 417-420.

• 管理及工作研究 • 上一篇    下一篇

从清开灵ADR/ADE报告和说明书分析看儿童安全用药

陈建玉, 张惠霞   

  1. 河南省食品药品评价中心,河南 郑州 450004
  • 收稿日期:2016-02-22 修回日期:2016-02-22 出版日期:2010-07-08 发布日期:2016-02-22
  • 作者简介:陈建玉,女,高级工程师,药品不良反应监测。

Review on the Medication Safety of Children from the Analysis of ADR/ADE Reports by Qingkailing Injection and Instructions

CHEN Jian-yu, ZHANG Hui-xia   

  1. Henan Food and Drug Reevaluation Center, Henan Zhengzhou 450004, China
  • Received:2016-02-22 Revised:2016-02-22 Online:2010-07-08 Published:2016-02-22

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摘要： 目的 通过分析861例儿童清开灵注射液的药品不良反应/不良事件报告及药品说明书,为儿童合理用药与企业完善说明书提供参考。方法 采用回顾性研究方法,对河南药品不良反应监测中心数据库收集的2004年~2009年清开灵的药品不良反应/不良事件报告及国内9个厂家的药品说明书进行统计和分析。结果 3岁以下儿童364例 （占42.28%）;联合用药140例（16.26%）,其中3岁以下儿童64例（45.71%）;超适应证242例（28.11%）;说明书中儿童安全用药信息和用法用量缺失。结论 关注儿童合理用药,完善药品说明书,保障儿童用药安全。

关键词: 儿童, 清开灵注射液, 说明书, 安全用药

Abstract: Objective By analyzing 861 ADR/ADE reports of children Qingkailing injection and the drug instructions, to provide reference for reasonably using children medicines and improving the enterprise's drug instruction. Methods Using retrospective research, we counted and analyzed Qingkailing ADR/ADE reports during 2004~2009 from Henan center for drug reevaluation and the drug instructions of nine domestic pharmaceutical enterprises. Results There are 364 cases of child under 3 years of age(42.28%),140 cases of drug combination(16.26%) in which 64 cases are of child under 3 years of age(45.71%), 242 cases of ultra-indications(28.11%). The drug instruction lacks information for children's safety and the dosage. Conclusion It should be concern about the rational use of drug for children, improve the drug instruction, and ensure the medication safety for children.

Key words: children, Qingkailing injection, instruction, medication safety

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