Utz P J
Division of Immunology and Rheumatology, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, USA.
Lupus. 2004;13(5):304-11. doi: 10.1191/0961203303lu1017oa.
Validated biomarkers and surrogate markers are badly needed for monitoring patients with systemic lupus erythematosus (SLE), both for routine clinical care and for clinical trials research. SLE is difficult to study in clinical trials, in part because the disease is so heterogeneous. Very few useful markers have been identified, and even those that historically have been thought to be valid have been recently questioned. This report will focus on the use of emerging multiplexed assay formats that enable analysis of hundreds or even thousands of analytes simultaneously. Their potential and pitfalls for monitoring patients with SLE, particularly those enrolled in clinical trials testing novel therapeutics, will be discussed.
无论是在常规临床护理还是临床试验研究中,系统性红斑狼疮(SLE)患者的监测都急需经过验证的生物标志物和替代标志物。SLE在临床试验中很难进行研究,部分原因是该疾病具有高度异质性。目前仅发现了极少数有用的标志物,甚至那些过去被认为有效的标志物最近也受到了质疑。本报告将重点关注新兴的多重检测方法,这些方法能够同时分析数百甚至数千种分析物。将讨论它们在监测SLE患者,特别是参与新型疗法临床试验的患者方面的潜力和缺陷。