Econometric Institute, Erasmus University Rotterdam, The Netherlands.
Stat Med. 2011 May 30;30(12):1419-28. doi: 10.1002/sim.4194. Epub 2011 Jan 26.
Drug benefit-risk (BR) analysis is based on firm clinical evidence regarding various safety and efficacy outcomes. In this paper, we propose a new and more formal approach for constructing a supporting multi-criteria model that fully takes into account the evidence on efficacy and adverse drug reactions. Our approach is based on the stochastic multi-criteria acceptability analysis methodology, which allows us to compute the typical value judgments that support a decision, to quantify decision uncertainty, and to compute a comprehensive BR profile. We construct a multi-criteria model for the therapeutic group of second-generation antidepressants. We assess fluoxetine and venlafaxine together with placebo according to incidence of treatment response and three common adverse drug reactions by using data from a published study. Our model shows that there are clear trade-offs among the treatment alternatives.
药物的获益-风险（BR）分析是基于有关各种安全性和疗效结果的可靠临床证据。在本文中，我们提出了一种新的、更为正式的方法来构建一个支持性的多标准模型，该模型充分考虑了疗效和药物不良反应的证据。我们的方法基于随机多标准可接受性分析方法，该方法允许我们计算支持决策的典型价值判断，量化决策不确定性，并计算综合的 BR 概况。我们为第二代抗抑郁药治疗组构建了一个多标准模型。我们根据一项已发表研究的数据，使用治疗反应发生率和三种常见药物不良反应，对氟西汀和文拉法辛与安慰剂进行了评估。我们的模型表明，治疗选择之间存在明显的权衡。
