摘要
目的总结湖北省儿童药品不良反应(ADR)发生的特点和规律,为儿童临床安全用药提供参考。方法采用回顾性研究方法,收集2014年1月—2018年12月湖北省药品(医疗器械)不良反应监测中心的38425例儿童ADR报告,从患者的性别、年龄、用药基本情况、ADR发生及上报情况等方面进行统计分析。结果38425例ADR报告中患儿男女比例为1.49:1;0~6岁患者构成比较高;给药途径以静脉注射为主,联合用药占23.7%;ADR累及系统器官主要包括皮肤及其附件损害(47.3%)、全身性损害(27.1%)、胃肠道紊乱(18.4%);12~14岁严重报告比例最高(10.4%);ADR上报人员以医生、药师和护士为主。结论儿童中存在严重ADR,在临床用药过程中需要密切关注加强监测,特别是婴幼儿,以提高用药安全性。
Objective To summarize the characteristics and regularity of adverse drug reactions(ADR)for the children in Hubei province,and to provide a reference for children's clinical drug safety.Methods A retrospective study was performed on 38,425 children's ADR reports,which were collected by Hubei Center for ADR/ADE Monitoring from January 2014 to December 2018.Statistical analyses were performed on the patient's gender,age,basic medication,ADR occurrence,and other reported situations.Results The ratio of males to females in those 38425 ADR patients was 1.49:1.The composition of patients aged from 0 to 6 was relatively high.The main route of administration was intravenous injection,and the proportion of combined medication was 23.7%.The skin and organs involved in ADR were mainly skin and its annex damage(47.3%),systemic damage(27.1%),and gastrointestinal disorders(18.4%).The highest proportion of serious reports were reported from 12 to 14 years old.ADR reporting personnel were mainly doctors,pharmacists,and nurses.Conclusion Children have serious ADRs,so it is need to pay close attention and strengthen the monitoring during clinical medication,especially for infants and young children.
作者
陈莉
何娟
上官小芳
黄锐
蔡沅璇
杨明磊
赵丽
CHEN Li;HE Juan;SHANGGUAN Xiaofang;HUANG Rui;CAI Yuanxuan;YANG Minglei;ZHAO Li(School of Management,Hubei University of Traditional Chinese Medicine,Wuhan 430065,China;School of Pharmacy,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Hubei Center for ADR/ADE Monitoring,Wuhan 430060,China)
出处
《医药导报》
CAS
北大核心
2020年第10期1362-1365,共4页
Herald of Medicine
基金
国家自然科学基金资助项目(71874062)。
