中国药物警戒 ›› 2018, Vol. 15 ›› Issue (2): 121-124.

• 安全与合理用药 • 上一篇    下一篇

CFDA发布的药品不良反应信息通报中儿童用药典型病例分析

赵瑞玲1, 张占慧2, 张冠东1   

  1. 1 山西省儿童医院，山西 太原030013;
    2 山西医科大学，山西 太原030001
  • 收稿日期:2017-10-29 修回日期:2018-03-28 出版日期:2018-02-20 发布日期:2018-03-28
  • 作者简介:赵瑞玲，女，硕士，主任药师，药事管理与临床药理。E-mail：ruiling.zhao@163.com
  • 基金资助:
    山西省卫生厅科研课题（20130142）：医院药学实践对儿童用药安全性的影响。

Typical Case Analysis of Children's Medication in Adverse Drug Reaction Information Bulletin of CFDA

ZHAO Rui-ling1, ZHANG Zhan-hui2, ZHANG Guan-dong1   

  1. 1 Children's Hospital of Shanxi, Shanxi Taiyuan 030013 China;
    2 Shanxi Medical University, Shanxi Taiyuan 030001 China
  • Received:2017-10-29 Revised:2018-03-28 Online:2018-02-20 Published:2018-03-28

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摘要： 目的 分析国家食品药品监督管理局（CFDA）网站发布的药品不良反应信息通报中儿童安全用药信息，促进儿童临床合理用药。方法 查询CFDA网站2001年11月19日至 2017年1月5日发布的药品不良反应信息通报，提取有关儿童安全用药信息。结果 共报道了40例儿童用药导致药品不良反应/事件的典型病例，其中一般药品不良反应/事件25例，占62.50％（25/40），严重药品不良反应/事件15例，占37.50％（15/40）。抗感染药物数量最多19例，占47.50％（19/40）。40例儿童用药导致药品不良反应/事件典型病例中，不合理用药高达75.00%。结论 需进一步呼吁全社会高度关注儿童安全用药，加强各级医务人员儿童合理用药培训和管理，从政策和法规层面解决儿童用药问题。

关键词: 儿童, 安全用药, 药品不良反应, 药品不良事件

Abstract: Objective To analyze the information of children's safe medication in Adverse Drug Reactions Information Bulletin published by China Food and Drug Administration (CFDA) website, and promote the rational use of medicines in children. Methods Check the information of adverse drug reactions released by CFDA website from November 19, 2001, to January 5, 2017, and extract information about the children's safe medication. Results A total of 40 cases of adverse drug reactions/events in children were reported. Among them, there were 25 cases of adverse drug reactions/events, accounting for 62.50% (25/40), and 15 cases of serious adverse drug reactions/events, accounting for 37.50% (15/40). The number of anti-infective drugs was up to 19 cases, accounting for 47.50 % (19/40). In the 40 cases of adverse drug reactions/events, the unreasonable drug use was up to 75.00%. Conclusion It is necessary to call for the whole community to pay close attention to children's safe medication, to strengthen the children's rational drug use training and management for medical staff at all levels, and to solve the problem of children's medication from the policy and legal level.

Key words: children, safe medication, adverse drug reactions, adverse drug events

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