国内8家儿童医院常用药品说明书中儿童用药信息的调查分析  

Investigation and Analysis into Children Medication Information in Pediatric Commonly-used Drug Instructions in 8 Children’s Hospitals

作　　者：闫聪聪 王晓玲[2] 张胜男 马瑞娟[1] 吴光华 刘蕾[1] 王瑞丽[1] 马姝丽 Yan Congcong;Wang Xiaoling;Zhang Shengnan;Ma Ruijuan;Wu Guanghua;Liu Lei;Wang Ruili;Ma Shuli(Dept.of Pharmacy,Children's Hospital Affiliated to Zhengzhou University,Zhengzhou 450000,China;Dept.of Pharmacy,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]郑州大学附属儿童医院药学部,郑州450000 [2]首都医科大学附属北京儿童医院药学部,北京100045

出　　处：《中国药事》2021年第1期10-15,共6页Chinese Pharmaceutical Affairs

基　　金：国家科技重大专项项目(编号2017ZX09304029);国家卫生健康委医管中心委托课题[编号医管中心药械处(2019)053]。

摘　　要：目的:调查我国儿童常用药品说明书中的儿童用药信息标注情况,为儿童合理用药提供参考。方法:以国内8家三甲儿童医院常用化学药品与生物制品作为研究对象,对说明书中的儿童用药信息进行统计分析。结果:儿科常用药品的2083个品规中,有注射剂1063个(占51.03%)、口服制剂808个(占38.79%)、外用制剂155个(占7.44%)、雾化吸入制剂57个(占2.73%);其中儿童专用药品品规数仅有74个(占3.55%)。儿科常用药品中标注相关信息分布:标注儿童用法用量的有1126个(占54.06%)、标注儿童最大剂量的有190个(占9.12%)、标注儿童用药疗程的有90个(占4.32%)、标注儿童用药注意事项的有537个(占25.78%)、标注儿童用药禁忌的有118个(占5.66%)、标注儿童相关不良反应的有190个(占9.12%)。结论:目前我国儿童专用药品少。儿科常用药品说明书中存在儿童用药信息缺乏,且存在同一药品说明书差异大、说明书内容表述不规范等问题。建议相关部门加强对药品说明书内容的审核力度,督促药品生产企业完善说明书中儿童用药信息,加强对药品说明书的规范和管理,保证说明书各项目的完整性及内容的准确性,促进药物的合理使用。Objective:To investigate the children medication information in the instructions of pediatric commonly-used medicines in our country and provide references for children's rational use of drugs.Methods:The children medication information about the pediatric commonly-used chemicals and biologicals in the drug instructions of eight 3A children's hospitals were collected and statistically analyzed.Results:A total of 2083 pediatric commonly-used medicines were collected,including 1063 injections(51.03%),808 oral dosage forms(38.79%),155 external preparations(7.44%)and 57 atomization inhalation formulations(2.73%).There are only 74 special drugs for children(3.55%)among the pediatric commonly-used medicines.1126 items(54.06%)were marked for children’s usage and dosage.190 items(9.12%)were marked for children’s maximum dosage.90 items(4.32%)were marked for children’s treatment course.537 items(25.78%)were marked for the notice of children medication.118 items(5.66%)were marked for taboos on children medication.190 items(9.12%)were marked for children’s adverse reactions.Conclusion:Medicines special for children are insufficient in our country.The information on children medication in the instructions of pediatric commonly-used medicines is deficient,and there exist some problems such as great differences in the same drug instructions,non-standard expression of the contents in the instructions and so on.It is suggested that the relevant departments should strengthen the audit of drug instruction contents,urge pharmaceutical enterprises to improve the instructions about children medication information,strengthen the standardization and management of drug instructions,guarantee the completeness of items and the accuracy of the contents of the instructions,and promote the rational use of drugs.

关 键 词：药品说明书 儿童用药 调查分析 

分 类 号：R95[医药卫生—药学] R969.3[医药卫生—药理学]