《国家基本药物目录》中化学药与中成药不良反应项的对比分析(1)
【摘 要】 目的：调查分析药品说明书中不良反应项的现状，为完善我国药品说明书提供建议和参考。方法：采用文献检索法，收集2012年《国家基本药物目录》下500份药品说明书，将其分为化学药和中成药；在我国药品说明书和标签管理规定的基础上，结合美国相关指导原则，对目录下中成药与化学药说明书中不良反应项内容的完整性与科学性作出评价。结果：中成药的不良反应项标注率和内容完整度远低于化学药；在药品说明书不良反应项中术语的使用也存在不规范现象。结论：基药说明书中不良反应项内容，特别是中成药的相关内容仍需进一步完善。
【关键词】 《国家基本药物目录》；化学药；中成药；不良反应项；评价
【中图分类号】R95 【文献标志码】 A【文章编号】1007-8517(2016)24-0090-03
Abstract：Objective To investigate and analyze the adverse reactions descriptions in pharmaceutical instructions of essential drugs in order to propose suggestions and basis for improving pharmaceutical instructions in China. Methods A total of 500 pharmaceutical instructions were collected by literature mining and categorized as chemical drugs and Chinese patent drugs. The extent of integrity and scientific authenticity of adverse reaction descriptions in pharmaceutical instructions of both chemical drugs and Chinese patent drugs was evaluated. Administrative regulations on pharmaceuticalinstructionsand labels in China were employed as the majorcriterion while related guidelines proposed by FDA in US were adjuvant reference in the evaluation. Results Among all 500 subjects ......
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【关键词】 《国家基本药物目录》；化学药；中成药；不良反应项；评价
【中图分类号】R95 【文献标志码】 A【文章编号】1007-8517(2016)24-0090-03
Abstract：Objective To investigate and analyze the adverse reactions descriptions in pharmaceutical instructions of essential drugs in order to propose suggestions and basis for improving pharmaceutical instructions in China. Methods A total of 500 pharmaceutical instructions were collected by literature mining and categorized as chemical drugs and Chinese patent drugs. The extent of integrity and scientific authenticity of adverse reaction descriptions in pharmaceutical instructions of both chemical drugs and Chinese patent drugs was evaluated. Administrative regulations on pharmaceuticalinstructionsand labels in China were employed as the majorcriterion while related guidelines proposed by FDA in US were adjuvant reference in the evaluation. Results Among all 500 subjects ......
您现在查看是摘要页，全文长 3624 字符。