药品不良反应信号检测方法概述

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (2): 78-80.

药品不良反应信号检测方法概述

江静¹, 侯永芳², 刘秀娟¹, 任经天², 金少鸿^2*

1广东省药品不良反应监测中心,广州 510080;
2国家食品药品监督管理局药品评价中心,北京 100045

收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-02-08 发布日期:2016-02-19
通讯作者: 金少鸿,研究员。本课题负责人,国家食品药品监督管理局药品评价中心。
作者简介:江静,女,硕士,药品安全性监测。
基金资助:
基金项目：十一五国家科技支撑计划项目（2006BAI14B03）“安全用药监测研究与预警技术系统的研究及应用”

Overview of Adverse Drug Reaction Signal Detection Methods

JIANG Jing¹, HOU Yong-fang², LIU Xiu-juan¹, REN Jing-tian², JIN Shao-hong^2,*

1Guangdong Center for ADR Monitoring, Guangdong Guangzhou 510080, China;
2Center for Drug Reevaluation, SFDA, Beijing 100045, China

Received:2016-02-19 Revised:2016-02-19 Online:2010-02-08 Published:2016-02-19

摘要/Abstract

摘要： 药品不良反应监测工作是药品监督管理体系的重要组成部分,而药品不良反应信号的检测是药品不良反应监测工作中最重要的技术工作。通过对国际上发达国家药品不良反应信号的检测方法进行研究,以期为我国药品不良反应信号检测及预警系统建设提供参考。

关键词: 药品不良反应, 信号检测, 方法

Abstract: Adverse Drug Reaction(ADR) monitoring work is an important component of drug supervision and admin-istration system. Analysis and evaluation of ADR signal is the most important technical work in ADR monitoring. In this paper, we analyzed the ADR signal evaluation method on developed countries by researching domestic and foreign literature and addressed some useful suggestion on ADR signal detection work in our country.

Key words: adverse drug reaction(ADR), signal detection, method

中图分类号:

江静, 侯永芳, 刘秀娟, 任经天, 金少鸿. 药品不良反应信号检测方法概述[J]. 中国药物警戒, 2010, 7(2): 78-80.

JIANG Jing, HOU Yong-fang, LIU Xiu-juan, REN Jing-tian, JIN Shao-hong. Overview of Adverse Drug Reaction Signal Detection Methods[J]. Chinese Journal of Pharmacovigilance, 2010, 7(2): 78-80.

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