Rockwood Kenneth
Division of Geriatric Medicine, Dalhousie University and Centre for Health Care of the Elderly, Capital District Health Authority, 1421-5955 Veterans Memorial Lane, Halifax, NS, Canada B3H 2E1.
Int J Alzheimers Dis. 2011;2011:598175. doi: 10.4061/2011/598175. Epub 2011 Oct 18.
It is often surprisingly difficult to tell whether a treatment for Alzheimer's disease is effective. Biomarkers might offer the potential of a quantifiable objective measure of treatment effectiveness. This paper suggests several criteria by which biomarkers might be evaluated as outcomes measures. These include biological plausibility, statistical significance, dose dependence, convergence across measures, and replicability. If biomarkers can meet these criteria, then, pending regulatory approval, they may have a role in the evaluation of treatment effectiveness in Alzheimer's disease. If not, their usefulness may be in supplementing, but not supplanting, clinical profiles of treatment effects.
判断一种治疗阿尔茨海默病的方法是否有效往往出人意料地困难。生物标志物可能提供一种可量化的客观治疗效果衡量标准。本文提出了几个标准，据此可将生物标志物评估为疗效指标。这些标准包括生物学合理性、统计学显著性、剂量依赖性、不同指标间的一致性以及可重复性。如果生物标志物能够满足这些标准，那么在获得监管批准之前，它们可能在评估阿尔茨海默病治疗效果方面发挥作用。如果不能满足，其作用可能是补充而非取代治疗效果的临床概况。
