Yetley Elizabeth A, DeMets David L, Harlan William R
Office of Dietary Supplements and
Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI.
Am J Clin Nutr. 2017 Nov;106(5):1175-1189. doi: 10.3945/ajcn.117.164046. Epub 2017 Oct 11.
Surrogate biomarkers for clinical outcomes afford scientific and economic efficiencies when investigating nutritional interventions in chronic diseases. However, valid scientific results are dependent on the qualification of these disease markers that are intended to be substitutes for a clinical outcome and to accurately predict benefit or harm. In this article, we examine the challenges of evaluating surrogate markers and describe the framework proposed in a 2010 Institute of Medicine report. The components of this framework are presented in the context of nutritional interventions for chronic diseases. We present case studies of 2 well-accepted surrogate markers [blood pressure within sodium intake and cardiovascular disease (CVD) context and low density lipoprotein-cholesterol concentrations within a saturated fat and CVD context]. We also describe additional cases in which the evidence is insufficient to validate their surrogate status. Guidance is offered for future research that evaluates or uses surrogate markers.
在研究慢性疾病的营养干预措施时，临床结局的替代生物标志物具有科学和经济效率。然而，有效的科学结果取决于这些疾病标志物的质量，这些标志物旨在替代临床结局并准确预测益处或危害。在本文中，我们探讨了评估替代标志物的挑战，并描述了2010年医学研究所报告中提出的框架。该框架的组成部分在慢性疾病营养干预的背景下呈现。我们展示了2个被广泛接受的替代标志物的案例研究[钠摄入与心血管疾病（CVD）背景下的血压，以及饱和脂肪与CVD背景下的低密度脂蛋白胆固醇浓度]。我们还描述了其他证据不足以证实其替代地位的案例。为未来评估或使用替代标志物的研究提供了指导。
