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| 中药上市后安全性再评价方法探讨 | |
| 引用本文： | 寇秋爱,赵素萍,冯国双,谢雁鸣. 中药上市后安全性再评价方法探讨[J]. 中国中药杂志, 2011, 36(20): 2771-2775 |
| 作者姓名： | 寇秋爱 赵素萍 冯国双 谢雁鸣 |
| 作者单位： | 1. 中国中医科学院西苑医院,北京,100091 2. 山西省晋中市中医院,山西晋中,030600 3. 北京市朝阳区疾病预防控制中心,北京,100021 4. 中国中医科学院中医临床基础医学研究所,北京,100700 |
| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目 (Z0133) |
| 摘 要： | 中药安全性再评价是中药上市后再评价的重要内容,也是首要的问题,主要包括安全性监测和安全性评价两大部分.我国已经初步建立了中药安全性监测体系,但在安全性评价方面做的工作很少,突出表现在评价方法的建立与实施方面经验不足,近年来人们逐渐认识到药物流行病学的方法在中药上市后安全性再评价中有很好的实用性.该文分析3种典型的药物流行病学方法在中药上市后安全性再评价中的应用,并举例说明,以期对同行有所提示. |
| 关 键 词： | 中药 安全性再评价 药物流行病学 |
| 收稿时间： | 2011-08-06 |
Study on method on post-marketing traditonal Chinese medicine safety assessment |
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| KOU Qiuai,ZHAO Suping,FENG Guoshuang and XIE Yanming. Study on method on post-marketing traditonal Chinese medicine safety assessment[J]. China Journal of Chinese Materia Medica, 2011, 36(20): 2771-2775 | |
| Authors: | KOU Qiuai ZHAO Suping FENG Guoshuang XIE Yanming |
| Affiliation: | Xiyuan Hospital, China Academy of Chinese Medical Sciences, Bejing 100091, China;Traditional Chinese Medicine Hospital of Jinzhong, Jinzhong 030600, China;Chaoyang District Centers for Disease Control and Prevention, Beijing 100021, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China |
| Abstract: | Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation.China has established the elementary system for the TCM safety monitoring,but did few things on safety evaluation. People have knew that the metheds of pharmacoepidemiology have good practicability on drug safety assessment in recent years.This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM. |
| Keywords: | traditional Chinese medicine safety assessment pharmacoepidemiology |
| 本文献已被 CNKI 万方数据 PubMed 等数据库收录！ | |