药品说明书中儿童禁用的原因分析  

Analysis of the reasons for contraindication in pediatric patients in drug labels

作　　者：张云霞[1] 秦倩倩[1] 赵瑞玲[2] 王晓玲[3] Zhang Yunxia;Qin Qianqian;Zhao Ruiling;Wang Xiaoling(Department of Pharmacy,Children′s Hospital of Shanxi,Taiyuan 030013,China;Office of Clinical Trial Institution,Children′s Hospital of Shanxi,Taiyuan 030013,China;Department of Pharmacy,Beijing Children′s Hospital,Capital Medical University,National Center for Children′s Health,Beijing 100045,China)

机构地区：[1]山西省儿童医院药剂科,太原030013 [2]山西省儿童医院临床试验机构办公室,太原030013 [3]国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京100045

出　　处：《药物不良反应杂志》2024年第9期557-562,共6页Adverse Drug Reactions Journal

基　　金：国家"十三五"科技重大专项增补任务(2017ZX09304029-001-001)。

摘　　要：目的调查我国现有药品说明书中标注了儿童禁用的化学药品和生物制品的禁用原因。方法筛选2020年版《中华人民共和国药典》收载的化学药品与生物制品及2023年国家基本医疗保险、工伤保险和生育保险药品目录西药部分药品说明书中标注为儿童禁用的药品,通过查询药品说明书、2020年版《中华人民共和国药典临床用药须知》、国家药品监督管理局(NMPA)网站和美国药品说明书,收集儿童禁用的原因并进行描述性分析。结果药品说明书中标注为儿童禁用的药品共有222种,涉及20个类别,其中抗感染药和消化系统用药最多。137种(61.7%)药品可查询到儿童禁用的原因,主要为药物不良反应(65.7%,90/137)、有效性和安全性尚未确定(30.7%,42/137),其次为辅料安全性问题(1.5%,2/137)、处方设计或成分不适合儿童(1.5%,2/137)、剂型不适宜(0.7%,1/137)。禁用原因来源包括国内药品说明书(100个)、美国药品说明书(17个)、NMPA网站说明书修订公告和科普知识(15个)、2020年版《中华人民共和国药典临床用药须知》(5个)。结论我国标注儿童禁用的药品说明书中未说明禁用原因和说明不规范的现象较为普遍,应进一步规范性撰写儿童禁用信息,并予不断更新和完善,以便为临床提供及时和最新的药物使用信息。Objective To investigate the reasons for contraindication of chemical drugs and biological products that were marked as contraindication for children in drug labels in China.Methods The drugs labeled as contraindication for children in drug labels of chemicals and biological products covered by the China Pharmacopoeia 2020 and the 2023 China′s Basic Medical Insurance,Work-related Injury Insurance and Childbirth Insurance(western medicine)were searched.The reasons of contraindication for children were collected through searching the drug labels,Clinical Medication Instructions of the China Pharmacopoeia 2020,the website of the National Medical Products Administration,and drug labels from the Unite States,and analyzed descriptively.Results There were 222 drugs were labeled as contraindication for children in the drug labels,involving 20 categories and mainly antibiotics and digestive system drugs.Among 222 drugs,137(61.7%)had the reasons for contraindication in pediatric patients,and the main reasons were adverse drug reactions(65.7%,90/137)and lack of effectiveness and safety information yet in children(30.7%,42/137),followed by the unsafe auxiliary materials(1.5%,2/137),unsuitable prescription design or ingredients for children(1.5%,2/137)and unsuitable dosage form for children(0.7%,1/137).The above reasons were collected from domestic drug instructions(100 drugs),U.S.drug labels(17 drugs),NMPA website instructions revision announcements and popular science knowledge(15 drugs),and Clinical Medication Instructions of the China Pharmacopoeia 2020(5 drugs).Conclusions It is relatively common in China to label drugs that are contraindicated for children without specifying the reasons for contraindication or with non-standard explanations in the instructions.Therefore,it is necessary to further standardize the contraindication information for children and apply continuous updates and improvement in order to provide timely and up-to-date drug use information for clinical practice.

关 键 词：儿童 药物标签 禁忌 原因 

分 类 号：R95[医药卫生—药学]