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| 重视药物警戒在中药注射剂上市后安全性监测中的应用 | |
| 引用本文： | 王海南,陈文,傅政,杜文民,贺佳. 重视药物警戒在中药注射剂上市后安全性监测中的应用[J]. 中国中药杂志, 2008, 33(5): 612-614 |
| 作者姓名： | 王海南 陈文 傅政 杜文民 贺佳 |
| 作者单位： | 1. 国家食品药品监督管理局,药品审评中心,北京,100038;第二军医大学,卫生勤务学系,卫生统计学教研室,上海,200433 2. 第二军医大学,卫生勤务学系,卫生统计学教研室,上海,200433 3. 上海市药品不良反应监测中心,上海,200000 |
| 摘 要： | 中药注射剂是近几年中药新药研发的热点之一,但其临床发生的严重不良反应引起了全社会的广泛关注,对其开展上市后安全性监测具有紧迫性。本研究根据中药注射剂发生安全性问题的原因及药品不良反应监测的发展趋势,阐述了药物警戒在中药注射剂上市后安全性监测中应用的必要性,并简要介绍了运用数据挖掘技术对自发呈报系统数据库进行快速信号检测的方法。 |
| 关 键 词： | 中药注射剂 药物警戒 安全性监测 |
| 文章编号： | 1001-5302(2008)05-0612-03 |
| 收稿时间： | 2007-08-14 |
| 修稿时间： | 2007-08-14 |
Necesity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections |
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| WANG Hai-nan ;CHEN Wen ;FU Zheng ;DU Wen-min ;HE Jia. Necesity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections[J]. China Journal of Chinese Materia Medica, 2008, 33(5): 612-614 | |
| Authors: | WANG Hai-nan CHEN Wen FU Zheng DU Wen-min HE Jia |
| Affiliation: | Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China. md_wanghainan@yahoo.com.cn |
| Abstract: | Traditional Chinese medicine(TCM)injection has become one of the hotspots in the new TCM research and development.The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society.It's very urgent to monitor the post-marketing safety of TCM injections.This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections,basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring.Also,this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology. |
| Keywords: | traditional Chinese medicine injections pharmacovigilance safety monitoring |
| 本文献已被 维普 万方数据 等数据库收录！ | |