Lin David, Hollander Zsuzsanna, Meredith Anna, McManus Bruce M
NCE CECR Centre of Excellence for Prevention of Organ Failure.
Can J Cardiol. 2009 Jun;25 Suppl A(Suppl A):9A-14A. doi: 10.1016/s0828-282x(09)71048-7.
Cardiovascular diseases impose enormous social and economic burdens on both individual citizens and on society as a whole. Clinical indicators such as high blood pressure, blood cholesterol and obesity have had some utility in identifying those who are at increased risk of cardiovascular events. However, there remains an urgent need for sensitive and specific indicators, preferably acquired through minimally invasive means, to help stratify patients for more personalized health care. As such, there has been a steadily growing interest in searching for 'omic' biomarkers of cardiovascular diseases. Historically, the transition of cardiac biomarker discovery to implementation has been a lengthy and somewhat unregulated process. Recent technological advancements, as well as concurrent efforts by regulatory agencies such as the Food and Drug Administration (United States) and Health Canada to establish policies and guidelines in the 'omic' arena, have helped propel the discovery and validation of biomarkers forward. The present paper provides perspective on current strategies in the biomarker development pathway, as well as the potential limitations associated with each step from discovery to clinical uptake. Canadian biomarker studies now underway illustrate the possibilities for assessment of risk, diagnosis, prognosis and response to therapy, and for the drug discovery process.
心血管疾病给公民个人乃至整个社会都带来了巨大的社会和经济负担。诸如高血压、血液胆固醇和肥胖等临床指标在识别心血管事件风险增加的人群方面具有一定作用。然而,迫切需要敏感且特异的指标,最好是通过微创手段获取的指标,以帮助对患者进行分层,实现更个性化的医疗保健。因此,人们对寻找心血管疾病的“组学”生物标志物的兴趣与日俱增。从历史上看,心脏生物标志物从发现到应用的转变是一个漫长且缺乏规范的过程。近期的技术进步,以及美国食品药品监督管理局和加拿大卫生部等监管机构在“组学”领域同步努力制定政策和指南,推动了生物标志物的发现和验证进程。本文阐述了生物标志物开发途径中的当前策略,以及从发现到临床应用每个步骤可能存在的局限性。目前正在进行的加拿大生物标志物研究展示了在风险评估、诊断、预后和治疗反应评估以及药物发现过程中的可能性。