2015—2019年天津市医疗机构儿童新的和严重的药品不良反应(事件)报告分析  

Analysis of new and severe adverse drug reactions reports of children in Tianjin medical institutions from 2015 to 2019

作　　者：刘颖[1] 王雨萍[2] 白海蓬 宋立刚 Liu Ying;Wang Yuping;Bai Haipeng;Song Ligang(Tianjin Center for Adverse Drug Reaction Monitoring,Tianjin 300191;Tianjin Children's Hospital,Tianjin 300074;Tianjin Institute for Food Safety Inspection Technology,Tianjin 300308)

机构地区：[1]天津市药品不良反应监测中心,天津300191 [2]天津市儿童医院,天津300074 [3]天津市食品安全检测技术研究院,天津300308

出　　处：《天津药学》2020年第4期12-15,20,共5页Tianjin Pharmacy

摘　　要：目的:分析儿童新的和严重的药品不良反应(事件)报告的特点,为促进安全合理用药提供参考。方法:对2015-2019年天津市药品不良反应监测系统中医疗机构报告的儿童新的和严重的不良反应(事件)报告进行分析,包括性别、年龄、剂型、给药途径、药品的种类、累及的系统/器官及临床表现等。结果:儿童不良反应(事件)报告共984份,新的和严重的不良反应(事件)报告97份,男女性别比为1.49∶1,3~6岁儿童比例最高。剂型以注射剂为主,涉及药品11类72种,最多的为抗感染药物,累及系统/器官最多的是消化系统,最严重的表现为过敏性休克和意识障碍。超说明书使用占15.53%。结论:应完善儿童药物临床试验及伦理学政策规定,支持鼓励儿童专用药品的研发和生产,加强儿童用药药物警戒工作,促进儿童安全合理用药。Objective:To analyze the characteristics of new and severe adverse drug reactions(ADR)reports in children and provide references for promoting safe and rational drug use.Methods:Severe and new ADR reports in children reported by medical institutions in the Tianjin ADR monitoring system from 2015 to 2019 were analyzed,including gender,age,dosage form,route of administration,type of drug,system/organ involved,and clinical manifestations.Results:A total of 984 adverse reactions/events were reported in children,including 97 severe and new ADR reports.The ratio of male and female was 1.49∶1,and the proportion of children aged 3 to 6 years was the highest.The dosage form was mainly injection,involving 11 categories and 72 drugs,of which the most involved were anti-infective drugs.The most involved system/organ was the digestive system,and the most severe manifestations were anaphylactic shock and disturbance of consciousness.The proportion of off-label use was 15.53%(16 cases).Conclusions:It is necessary to improve the clinical trials and ethical policies for children's drugs,support and encourage the research and development for production of children's special drugs,strengthen the pharmacovigilance work for children's drug use,and promote safe and rational drug use for children.

关 键 词：儿童 药品不良反应 安全合理用药 

分 类 号：R969[医药卫生—药理学]