国产中成药说明书现状调研与修订完善建议

Status and Improving Suggestions of the Leaflets of Domestic Chinese Patent Drugs

目的:梳理国产中成药说明书现状,提出修订完善的思考与建议。方法:文献检索、实地收集相结合获取1 618份国产中成药说明书,按照药品说明书相关条例规定,对处方药说明书25项条目、非处方药说明书18项条目内容的标注情况分类统计。结果:共纳入1 618份说明书,其中处方药1 000份,非处方药618份。处方药与非处方药说明书的基本信息、用药指导信息,如药品名称、成分、功能主治、用法用量等项标示率为100%、内容齐全;临床试验、药理毒理、药代动力学与药物相互作用项目内容标示率不高;安全性信息项目如警示语、不良反应、禁忌、注意事项、特殊人群用药等标示不全。结论:国产中成药说明书对保障临床合理用药至关重要,其项目内容的修订完善亟待从多方面开展。

Objective： To investigate the status of the leaflets of domestic Chinese patent drugs,and put forward our views and suggestions to improve them. Methods： 1 618 leaflets of domestic Chinese patent drugs were collected by fieldwork and literature retrieving. According to the relevant regulation of drug leaflets,all information of 25 items of prescription drugs and 18 items of over the counter drugs（ OTC） were extracted and analyzed by bibliometric and classification statistics. Results： 1 618 leaflets were included,1 000 of which were from prescription drugs,which the other were OTC.No matter the prescription or OTC drugs,the information for describing drugs and guiding patient medication was relatively complete,which labeling rate was 100%,such as name,composition,function,usage,while the information for clinical trials,pharma-toxicology,pharmacokinetic and drug interactions was deficit. The safety-related information,such as warmings,adverse drug reactions,contraindications and others,has deficiencies and incomplete statements,which may lead to medication risks. Conclusion： The leaflets of domestic Chinese patent drugs were rather important to ratimal drug use in clinic,its revision and improvement was urgent,which could be proceeded from many aspects.