基于多准则决策分析模型的药品获益风险评价方法

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (12): 752-754.

• 安全性评价与合理用药 • 上一篇下一篇

基于多准则决策分析模型的药品获益风险评价方法

熊玮仪,董铎*

国家食品药品监督管理总局药品评价中心，北京 10045

收稿日期:2017-08-28 修回日期:2018-01-19 出版日期:2017-12-20 发布日期:2018-01-19
通讯作者: 董铎，女，博士，主任药师，药品不良反应监测。E-mail：dongduo@cdr-adr.org.cn
作者简介:熊玮仪，女，博士，副研究员，流行病学、药品不良反应监测。
基金资助:
国家科技重大专项项目（2017ZX09101001-001-003）：药品再评价政策法规及实施策略研究。

Multiple Criteria Decision Analysis-Based Methodologies for Pharmaceutical Product Risk-Benefit Assessment

XIONG Wei-yi, DONG Duo*

Center for Drug Reevaluation, CFDA, Beijing 10045, China

Received:2017-08-28 Revised:2018-01-19 Online:2017-12-20 Published:2018-01-19

摘要/Abstract

摘要： 获益风险评价贯穿药品全生命周期管理，定量评价的重要性日益凸显，基于多准则决策分析模型的评价是目前国际监管机构推荐的定量评价方法之一。国际药物经济学和产出研究协会（ISPOR）于2016年提出了基于多准则决策分析（MCDA）模型在卫生决策领域的实施框架，并分步阐述了开展MCDA评价的注意事项。本文概要介绍了MCDA分析以及ISPOR提出的实施框架，以期为我国的相关工作提供参考。

关键词: 多准则决策分析, 获益风险评价

Abstract: Benefit-risk assessment is a critical issue throughout the whole life-cycle for pharmaceutical products. The importance of quantitative assessment has arisen. Assessment methodologies based on multiple criteria decision analysis (MCDA) are highly recommended by international regulatory authorities. In 2016, a task force from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) published an operational framework of MCDA application in health decisions and elaborated the key steps involved in implementing MCDA-based assessments. This paper aims to introduce MCDA and ISPOR framework to provide references to similar practices in China.

Key words: multi-criteria decision analysis, benefit-risk assessment

中图分类号:

R994.11

熊玮仪,董铎. 基于多准则决策分析模型的药品获益风险评价方法[J]. 中国药物警戒, 2017, 14(12): 752-754.

XIONG Wei-yi, DONG Duo. Multiple Criteria Decision Analysis-Based Methodologies for Pharmaceutical Product Risk-Benefit Assessment[J]. Chinese Journal of Pharmacovigilance, 2017, 14(12): 752-754.

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基于多准则决策分析模型的药品获益风险评价方法

Multiple Criteria Decision Analysis-Based Methodologies for Pharmaceutical Product Risk-Benefit Assessment

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