Renal Unit, Department of Health Sciences, "Magna Graecia" University of Catanzaro, I-88100 Catanzaro, Italy.
Department of Health Sciences, "Magna Graecia" University of Catanzaro, I-88100 Catanzaro, Italy.
Int J Mol Sci. 2020 Aug 14;21(16):5846. doi: 10.3390/ijms21165846.
Chronic kidney disease (CKD), defined as the presence of albuminuria and/or reduction in estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m, is considered a growing public health problem, with its prevalence and incidence having almost doubled in the past three decades. The implementation of novel biomarkers in clinical practice is crucial, since it could allow earlier diagnosis and lead to an improvement in CKD outcomes. Nevertheless, a clear guidance on how to develop biomarkers in the setting of CKD is not yet available. The aim of this review is to report the framework for implementing biomarkers in observational and intervention studies. Biomarkers are classified as either prognostic or predictive; the first type is used to identify the likelihood of a patient to develop an endpoint regardless of treatment, whereas the second type is used to determine whether the patient is likely to benefit from a specific treatment. Many single assays and complex biomarkers were shown to improve the prediction of cardiovascular and kidney outcomes in CKD patients on top of the traditional risk factors. Biomarkers were also shown to improve clinical trial designs. Understanding the correct ways to validate and implement novel biomarkers in CKD will help to mitigate the global burden of CKD and to improve the individual prognosis of these high-risk patients.
慢性肾脏病（CKD）定义为白蛋白尿和/或估计肾小球滤过率（eGFR）<60mL/min/1.73m 的降低，被认为是一个日益严重的公共卫生问题，在过去三十年中，其患病率和发病率几乎翻了一番。在临床实践中实施新型生物标志物至关重要，因为它可以更早地诊断疾病，并改善 CKD 的预后。然而，目前尚无关于如何在 CKD 环境中开发生物标志物的明确指导。本综述旨在报告在观察性和干预性研究中实施生物标志物的框架。生物标志物分为预后标志物和预测标志物；前者用于确定患者发生终点的可能性，而不论治疗情况如何，而后者用于确定患者是否可能从特定治疗中获益。许多单一检测和复杂生物标志物除了传统危险因素外，还可改善 CKD 患者心血管和肾脏结局的预测。生物标志物还可改善临床试验设计。了解正确的方法来验证和实施 CKD 中的新型生物标志物将有助于减轻全球 CKD 负担，并改善这些高危患者的个体预后。
