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。
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.
出处
《中国药物警戒》
2010年第7期417-420,共4页
Chinese Journal of Pharmacovigilance
关键词
儿童
清开灵注射液
说明书
安全用药
children
Qingkailing injection
instruction
medication safety
