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| 中成药说明书[禁忌]项的修订完善思考与建议 |
| View and Suggestions on Improving the Contraindications of the Leaflets of Chinese Patent Drugs |
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| DOI： |
| 中文关键词: 中成药 药品说明书 禁忌 完善 药物警戒 |
| 英文关键词:Chinese patent drugs Leaflets Contraindications Improvement |
| 基金项目: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） |
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| 中文摘要: |
| 摘 要 目的：针对中成药说明书[禁忌]项标注现状，提出修订完善思考与建议。方法：实地收集与文献检索相结合获取1 618个中成药示例品种的说明书实物，对其[禁忌]项标注率、标注内容进行统计分析。继而针对存在用药安全隐患的中西药复方制剂和含毒性药材中药制剂不同厂家说明书间的差异进行横向对比。结果：1 618个中成药品种的说明书均设置了[禁忌]项，其中43.1%的说明书提示了该药临床需禁用、忌用的内容，56.9%的标注为“尚不明确”，且在禁忌程度表述、禁忌内容选择方面存在不足。纳入中西药复方制剂、含毒性药材中药制剂的同品种不同厂家说明书3 562份，其中26个中西药复方制剂和74个含毒性药材中药制剂同品种不同厂家说明书[禁忌]项内容不同。造成[禁忌]项不完善的原因与说明书未能及时修订更新、禁忌内容入选标准不一等直接相关。结论：中成药说明书[禁忌]项是临床安全、合理用药的关键，针对其目前的不足，可以从数据来源、数据转化路径以及撰写模式三方面提供了修订完善建议，具有重要意义。 |
| 英文摘要: |
| ABSTRACT Objective:Investigating the statement status of “contraindications” in the leaflets of Chinese patent drugs, and putting forward our view and suggestions to improve it. Methods:The real leaflets of 1618 Chinese patent drugs were collected by fieldwork and literature retrieving. The setting rate and content of “contraindications” were statistics by bibliometric 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:All of 1618 leaflets set the “contraindications” item, in which 43.1% leaflets stated the details that the drugs need to be forbidden, while the others were stated “unclear”. And it also has some unsuitable in the terms of the statement of contraindication degree and the presentation of contraindication content. And in the 3652 leaflets that with the same species from different manufacturers, 60.5% species that contained chemical ingredients and 66.1% species that contained toxic ingredients had difference in contraindications information. After comprehensive analysis, the imperfections of leaflets were directly relative with their untimely revise and disunion of contraindication content. Conclusion:“Contraindications” item in the leaflets of Chinese patent drugs is the key of clinical safety and rational medication. In view of the shortcomings of “contraindications” item, our view and suggestions were put forward from the data source, data transformation path and writing mode. |
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