中国中药杂志

2013, v.38(18) 2919-2924

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中药上市后安全性医院集中监测技术规范(征求意见稿)
Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine(draft version for comments)

谢雁鸣;廖星;赵玉斌;黎明全;张允岭;马融;冼绍祥;刘健;李素云;温泽淮;杨忠奇;邹建东江苏省中医院;孙洪胜;何燕;李学林;姜俊杰;王志飞;黎元元;王连心;常艳鹏;杨薇;张雯;
XIE Yan-ming;LIAO Xing;ZHAO Yu-bin;LI Ming-quan;ZHANG Yun-ling;MA Rong;XIAN Shao-xiang;LIU Jian;LI Su-yun;WEN Ze-huai;YANG Zhong-qi;ZOU Jian-dong;SUN Hong-sheng;HE Yan;LI Xue-lin;JIANG Jun-jie;WANG Zhi-fei;LI Yuan-yuan;WANG Lian-xin;CHANG Yan-peng;YANG Wei;ZHANG Wen;Institute of Basic Clinical Medicine,China Academy of Chinese Medical Sciences;Traditional Chinese Medicine Hospital of Shijiazhuang Affiliated to Hebei Medical University;The Affiliated Hospital to Changchun University of Chinese Me

摘要(Abstract):

为了推动中药药品生产企业开展药品重点监测工作,积极响应国家食品药品监督管理总局发布的相关工作指南具有重要意义。因此,该技术规范在经过多次专家论证后,现公开征求意见,旨在为中药上市后安全性再评价监测研究真实报告不良反应/事件并进行客观评价提供技术支撑。该技术规范围绕中药上市后监测的关键环节进行阐述,目的是对大样本、观察性医院集中监测方案设计与实施;采用巢式病例对照设计对"过敏反应的发生特征及机制进行深入研究"的设计与实施进行指导。
It is of vital significance to conduct active post-marketing surveillance of Chinese medicine,as an active response to laws,rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions(ADRs) or adverse drug events( ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR / ADE characteristics,the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

关键词(KeyWords): 上市后中药;中药注射剂;安全性;医院集中监测;技术规范
post-marketing Chinese medicine;parenterally administered Chinese medicine;safety;intensive hospital monitoring;technical specifications

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基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09502-030)

作者(Author): 谢雁鸣;廖星;赵玉斌;黎明全;张允岭;马融;冼绍祥;刘健;李素云;温泽淮;杨忠奇;邹建东江苏省中医院;孙洪胜;何燕;李学林;姜俊杰;王志飞;黎元元;王连心;常艳鹏;杨薇;张雯;
XIE Yan-ming;LIAO Xing;ZHAO Yu-bin;LI Ming-quan;ZHANG Yun-ling;MA Rong;XIAN Shao-xiang;LIU Jian;LI Su-yun;WEN Ze-huai;YANG Zhong-qi;ZOU Jian-dong;SUN Hong-sheng;HE Yan;LI Xue-lin;JIANG Jun-jie;WANG Zhi-fei;LI Yuan-yuan;WANG Lian-xin;CHANG Yan-peng;YANG Wei;ZHANG Wen;Institute of Basic Clinical Medicine,China Academy of Chinese Medical Sciences;Traditional Chinese Medicine Hospital of Shijiazhuang Affiliated to Hebei Medical University;The Affiliated Hospital to Changchun University of Chinese Me

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