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药品不良反应术语集WHOART与MedDRA的应用探析
引用本文:刘晶,谢雁鸣,盖国忠,廖星. 药品不良反应术语集WHOART与MedDRA的应用探析[J]. 中国中药杂志, 2015, 40(24): 4728-4733
作者姓名:刘晶  谢雁鸣  盖国忠  廖星
作者单位:中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700,中国中医科学院 中医临床基础医学研究所, 北京 100700,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:中央级科研院所基本科研业务费项目(Z0406,PY1303);国家"重大新药创制"科技重大专项(2015ZX09501004-001-002)
摘    要:药品安全性问题一直是全球共同关注的焦点。而药品不良反应信息的准确采集对于药品不良反应的发现至关重要。药品不良反应术语集将不良反应报告的术语进行医学上有意义的分组汇总并使其标准化,有利于药品不良反应信息数据的准确采集。该文着重论述了国内广泛使用的术语集WHOART和MedDRA术语的概况、内容、结构及应用状况,浅析2种术语集之间的差异,并对中药不良反应术语的标准化以及在我国未来应用的趋势进行探讨。

关 键 词:药品不良反应术语集  WHOART  MedDRA  中药不良反应
收稿时间:2015-08-04

Application analysis of adverse drug reaction terminology WHOART and MedDRA
LIU Jing,XIE Yan-ming,GAI Guo-zhong and LIAO Xing. Application analysis of adverse drug reaction terminology WHOART and MedDRA[J]. China Journal of Chinese Materia Medica, 2015, 40(24): 4728-4733
Authors:LIU Jing  XIE Yan-ming  GAI Guo-zhong  LIAO Xing
Affiliation:Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China,Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China,Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China and Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
Abstract:Drug safety has always been a global focus. Discovery and accurate information acquisition of adverse drug reaction have been the most crucial concern. Terminology of adverse drug reaction makes adverse reaction medical report meaningful, standardized and accurate. This paper discussed the domestic use of the terminology WHOART and MedDRA in terms of content, structure, and application situation. It also analysed the differences between the two terminologies and discusses the future trend of application in our country.
Keywords:adverse drug reaction terminology  WHOART  MedDRA  adverse reaction of traditional Chinese medicine
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