中成药说明书[注意事项]的修订完善思考与建议  

View and Suggestions on Improving the ‘Precaution’ Section of the Leaflets of Chinese Patent Drugs

作　　者：刘欣[1] 张冰[1] 王海南[2] 张体灯[2] 薛菡 罗志 

机构地区：[1]北京中医药大学,北京100102 [2]国家食品药品监督管理总局药品注册司 [3]福建省食品药品监督管理局药品注册处 [4]贵州省食品药品监督管理局药品化妆品注册管理处(中药民族药监管处)

出　　处：《药物流行病学杂志》2018年第1期45-49,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:梳理中成药说明书项下[注意事项]标注现状,提出其修订完善建议与思考。方法:通过文献检索与实地收集相结合的方式随机获取1 618个中成药品种,对品种说明书项下[注意事项]整体标注率、内容完整程度进行频次统计和对比分析后,抽提出品种中的中西药复方制剂、含有毒性药材中药制剂,并横向对比同一品种不同厂家间说明书差异。结果:不同品种的1 618份说明书中有标注[注意事项]的有1 616份,缺失[注意事项]的2份。有详细内容者1 222份,其他均仅标注为"尚不明确"或"请遵医嘱"等,表现出标注的位置、格式、术语表达等方面的不足。对于155个品种中西药复方制剂、含毒性药材中药制剂的不同厂家3 562份说明书横向对比发现,不同厂家同一品种的说明书[注意事项]内容标注的差异较大。结论:以"数据的获取为依托,数据转化为手段,规范化撰写模式为目标"的一体化修改形式对中成药说明书项下的[注意事项]进行完善和补充,有助于为临床安全用药保驾护航。Objective：Investigating the statement status of the ‘precaution’ section based on the leaflets of Chinese patent drugs, and putting forward our view and suggestions to improve them. Methods：The real leaflets of 1 618 Chinese patent drugs which were selected randomly were collected by literature retrieving and fieldwork. The data of the section setting and content integrity of ‘precaution’ were statistics by bibliometric and comparative methods. And then, the difference between leaflets of the same species from different manufacturers were compared, which including the species contain chemical and toxic ingredients.Results：1 616 of 1 618 leaflets set the ‘precaution’ and 2 items were missing,in which 1 222 leaflets stated the details, the other of which leaflets stated ‘remains unclear’ or ‘please obey the doctor＇s advice’. The annotation location, format and terminology were still insufficient in leaflets set the ‘precaution’. For the 155 species of the ones that contained chemical ingredients and the others that contained toxic ingredients, the 3 652 information leaflets of the different manufacturers were comparison. Conclusion：The ‘precaution’ section in leaflets of Chinese patent drugs is the basis of clinical rational medication. About the shortcomings of the ‘precaution’ section, our view and suggestions were put forward from ‘the acquisition of data as basis, data transformation as a means, the standardized writing model as the goal’ and finally thus for clinical safe drug use.

关 键 词：中成药 药品说明书 注意事项 修订完善 药物警戒 

分 类 号：R286[医药卫生—中药学]