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药品安全性证据分级分类探索研究(1)
http://www.100md.com 2015年12月15日 《中国中药杂志》 2015年第24期
     [摘要] 借鉴循证医学既有证据分类、分级的成功经验,探索中药上市后安全性证据评价、分类和分级标准并形成安全性证据评价的基本框架,从点、线、面、体多个角度综合不同证据源,构建中药上市后安全性证据体,为今后该领域证据体系的研究提供方法学和技术支撑。

    [关键词] 安全性证据;上市后中药;证据分级;循证医学

    [Abstract] There has been much difference between effectiveness and harm in evidence evaluation Many evidence ranking or grading systems have been developed by researchers in the world However, no evidence ranking or grading systems are based on safety research reality Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence It is necessary to develop a new system for harm evidence We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work We do hope such an ideal could be helpful and indicative for evidence evaluation for harm

    [Key words] body of evidence; postmarteting traditional Chinese medicine; evidence grading; evidence based medicine

    doi:10.4268/cjcmm20152401

    自1992年循证医学(evidence based medicine ......
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