Hughes D A, Bayoumi A M, Pirmohamed M
Centre for Economics and Policy in Health, IMSCaR, University of Wales, Bangor, Gwynedd, UK.
Clin Pharmacol Ther. 2007 Aug;82(2):123-7. doi: 10.1038/sj.clpt.6100240.
Regulatory risk-benefit assessments may overweight small but serious risks relative to benefits. Using terfenadine and torsade de pointes as an exemplar, we illustrate how a different decision may result when outcomes are assessed using quality-adjusted life-years within a decision-analytical framework. The adoption of common measures of health outcome and the use of decision analyses, which will allow uncertainty to be characterized and evidence to be compiled from disparate sources, may inform complex risk-benefit decisions and should be used in conjunction with qualitative assessments.
监管方面的风险效益评估可能会相对于益处而高估虽小但严重的风险。以特非那定和尖端扭转型室速为例，我们说明了在决策分析框架内使用质量调整生命年评估结果时可能会得出不同的决策。采用常见的健康结果衡量指标以及使用决策分析，这将使不确定性得以描述，并能从不同来源收集证据，可为复杂的风险效益决策提供依据，且应与定性评估结合使用。
