中成药说明书中老年人用药信息修订完善思考  

Thought and Recommendations on Improving the Geriatric Pharmacy Information Section of the Information Leaflets of Domestic Chinese Patent Drugs

作　　者：边猛 张冰[1] 王海南[2] 张体灯[2] 

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》2017年第12期819-823,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;北京中医药大学教育科学研究重点课题(编号:XJY15002)

摘　　要：目的:梳理中成药说明书中老年人用药信息存在的潜在问题与风险,提出修订完善的思考与建议。方法:通过实地收集、文献检索方法获取1 572份中成药的药品说明书,提取说明书中各项涉及老年人用药的信息,分别与相关法规要求、文献报道的不良反应进行对比,并对比同一品种不同厂家说明书,采用文献计量学方法进行统计分析。结果:共纳入不同剂型的中成药说明书1 572份,包含处方药981份,非处方药591份。385份说明书包含老年人用药信息,分散于[用法用量]、[禁忌]、[注意事项]、[不良反应]、[老年用药]等项,其中368份说明书提示了老年人用药的注意事项,11份说明书提示了老年人用药时的不良反应、禁忌及用法用量。结论:中成药说明书对老年人用药的安全性信息提示率较低,且警示不足,不利于指导老年人群合理使用中成药。可通过扩大信息来源、规范转化路径和撰写模式进行完善,以保证老年人临床用药的安全与合理。Objective： Researching the potential problems and risks of the geriatric pharmacy information section in the information leaflets of domestic Chinese patent drugs, and coming up with our viewpoints and proposals to improve them. Methods： 1 572 varieties of Chinese patent medicine leaflets were selected randomly through field collection and lit- erature retrieval. The drug information of the elderly people involved in the extraction of the drug instructions were com- pared with the relevant regulatory requirements and the adverse reactions reported by the literature. In addition, the same variety of instructions in different manufacturers were compared, bibliometric methods were used for statistical analysis. Re- sults：l 572 samples of different dosage forms of Chinese patent medicine leaflets were chosen for study, including 981 pre- scribed drugs and 591 over-the-counter drugs. There were 385 instructions contained medical information for the aged peo- ple, distributing on ＂usage and dosage＂, ＂contraindications＂, ＂attentions＂, ＂adverse drug reactions＂, and ＂geriatric use＂. Among them, 368 instructions were given the precautions to the elderly for drug use, and 11 instructions suggested adverse reactions, contraindications and usage of the elderly people. Conclusion ： The reminder of geriatric pharmacy sug- gestions in information leaflets of domestic Chinese patent drugs was few, as well as inadequate warnings, which against guiding the rational use of Chinese medicine for elderly patients. This study put forward some views and suggestions on the revision and improvement of items from three aspects of data source, data transformation path and writing model.

关 键 词：中成药 药品说明书 老年人 修订完善 

分 类 号：R286[医药卫生—中药学]