摘要
目的:梳理中成药说明书中有关女性患者用药信息的标注现状,针对其存在的问题,提出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1 572个示例中成药品种的说明书实物,提取其中女性患者用药的各方面信息,对标注内容及分布情况进行频次统计和对比分析。结果:1 572份中成药说明书,其中64.6%提示了女性的用药信息,绝大多数为对孕期妇女的用药警戒。女性患者用药信息可见于说明书的警示语、[用法用量]、[不良反应]、[禁忌]、[注意事项]及[孕妇及哺乳期妇女用药]等6项,涉及内容丰富,包括特殊人群用药禁忌、饮食起居禁忌、给药时间、给药方式、疗程等,但仍存在警示语缺失、安全用药信息不全面、用药警戒对象局限、禁忌等级划分有待统一标准等问题。结论:中成药说明书对女性患者合理用药的关注度尚可,但警示内容仍不够全面,有待对说明书相关项目进行修订和完善,可按照扩大信息来源、明确转化路径和规范撰写模式等步骤实施。
Objective： Investigating the statement status of female pharmacy information in the leaflets of Chinese patent drugs, and putting forward our views and recommendations to improve them. Methods：Leaflets of 1 572 varieties of Chinese patent drugs were obtained through field collection and literature search. Using the methods of statistics analysis and comparative analysis on the content and integrity of the female pharmacy information. Results： 1 572 leaflet samples were collected, 64.6% of which pointed out female pharmacy information, most were about warning of pregnancy. The fe- male pharmacy information distributed in the section of ＂warning＂, ＂usage and dosage＂, ＂adverse drug reactions＂, ＂con- traindications＂, ＂attentions＂ and ＂pharmacy guidance for pregnancy and lactation＂. The information of above 6 section was abundant, including pharmacovigilance in special population, avoidable actions in daily life, time for medication, methods of medication, course of treatment, and so on. However, there were still some deficiencies, for example, some warning was absent, the information of medication safe was incomplete, and pharmacovigilance scope was limited, the grade for contraindications lack of uniform standards. Conclusion：The leaflets of Chinese patent medicine had a certain concern for female rational use of drugs, but its pharmacovigilance is still not comprehensive, which needs revision and im- provement. It can be revised and improved from three aspects of expanding data source, defining data transformation path and regulating writing model.
出处
《药物流行病学杂志》
CAS
2017年第10期708-711,共4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)
关键词
中成药
药品说明书
妇女用药信息
修订完善
药物警戒
Chinese patent drugs
Leaflets
Female pharmacy information
Revise and improve
Pharamacovigi lance
