中国药物警戒 ›› 2012, Vol. 9 ›› Issue (5): 286-289.

• 管理及工作研究 • 上一篇    下一篇

国外定量药品风险-效益评价方法简析

李姗1，许燕2，杨悦1，*   

  1. 1 沈阳药科大学工商管理学院，辽宁 沈阳 110016；
    2 广东省药品不良反应监测中心，广东 广州 510080
  • 收稿日期:2011-11-28 出版日期:2012-05-10 发布日期:2015-08-10
  • 通讯作者: 杨悦,女,副教授,博士研究生导师,药品政策、法规。E-mail：yyue315@126.com
  • 作者简介:李姗，女，在读硕士研究生，药事管理。

Brief Analysis of Foreign Quantitative Risk-Benefit Assessing Method of Medicines

LI Shan1, XU Yan2, YANG Yue1, *   

  1. 1 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016,China;
    2 Center for ADR monitoring of Guangdong, Guangdong Guangzhou 510080, China
  • Received:2011-11-28 Online:2012-05-10 Published:2015-08-10

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摘要： 目的分析和比较已有药品风险效益评价方法，为我国药品风险-效益评价提供参考。方法通过查阅国外文献，应用文献研究和比较研究的方法进行分析。结果FDA、EMEA已十分重视药品风险-效益评价，目前各种风险效益评价方法都存在自身的优势和劣势。结论监管机构应努力研究和探索适用于整个药品生命周期的、标准化的风险-效益评价方法。

关键词: 药品风险效益, 评价方法

Abstract: Objective To analyze and compare the existed medicine risk-benefit assessment methods and provide suggestions to our medicine risk-benefit assessment. MethodsLiterature study and comparative study were used to analyze and compare the foreign materials. ResultsFDA and EMEA has already attached much importance to medicine risk-benefit assessment, and now each of the existed risk-benefit assessment methods has its own strengthness and weakness. ConclusionRegulatory agencies should try to study and explore a standard method that can apply to the whole life period of medicines.

Key words: medicine risk-benefit, assessment method