中成药说明书中儿童用药信息的修订完善思考  

View and Recommendations on Improving Pediatric Pharmacy Information of the Leaflets of Chinese Patent Drugs

作　　者：林志健[1] 周伟龙[1] 张冰[1] 王海南[2] 张体灯[2] Lin Zhijian1 , Zhou Weilong , Zhang Bing, Wang Hainan2, Zhang Tideng2(1. Beijing University of Chinese Medicine, Beijing 100029, China; 2. The Pharmaceutical Registration Division of China Food and Drug Administratio)

机构地区：[1]北京中医药大学,北京100029 [2]国家食品药品监督管理总局药品注册司

出　　处：《药物流行病学杂志》2018年第4期244-248,共5页Chinese Journal of Pharmacoepidemiology

基　　金：国家食品药品监督管理总局中国食品药品国际交流中心研究课题项目;北京中医药大学教育科学研究重点课题项目(编号:XJY15002)

摘　　要：目的:对我国中成药说明书中有关儿童患者用药信息的标注现状进行梳理,针对存在的安全问题提出对相关项目修订完善的思考与建议。方法:通过实地收集、文献检索等方式获取1 618个示例中成药品种的药品说明书,提取儿童患者用药的相关信息,对标注内容及分布情况进行频次统计和对比分析。结果:1 618份中成药说明书中41.9%提示了儿童的用药信息,包括说明书警示语、[用法用量]、[不良反应]、[禁忌]、[注意事项]及[儿童用药]6项。儿童用药提示信息存在的问题主要包括儿童的特殊用量、禁忌及注意事项表述相对笼统,存在年龄范围不明确、安全用药信息不全面、警戒用语模糊等。结论:中成药说明书对儿童患者合理用药的关注有所欠缺,可从扩大信息来源、明确转化路径、规范撰写模式等方面对说明书相关项目进行修订和完善。Objective：To research the potential risk problems of the pediatric pharmacy information in the package inserts of Chinese patent drugs, and pose proposals to improve the drug package inserts. Methods：l 618 samples of package inserts of Chinese patent drugs were selected randomly through field collection and literature retrieval. The pediatric pharmacy information involved in the package inserts were investigated and analyzed according to legal documents in China. Results：l 618 samples of package inserts of Chinese patent drugs were chosen for study, and the rate of inserts labeled with pediatric pharmacy information items was 41.9%. These items included usage and dosage, adverse effects, contradictions, attention and child use. The major potential risk problems were obscurely labeled information of ＂usage and dosage＂, ＂contraindications＂, ＂attentions＂, ＂age classification＂, ＂adverse drug reactions＂ and ＂pharmaeovigilanee information＂, et al. Conclusion：The package inserts of Chinese patent drugs were lack of pediatric pharmacy information. It is urgent to improve the pediatric pharmacy information items in the package inserts of Chinese patent drugs. This study puts forward some suggestions on revision and improvement of these items from three aspects：data source, data transformation path and writing model.

关 键 词：中成药 药品说明书 儿童用药信息 修订完善 药物警戒 

分 类 号：R286[医药卫生—中药学]