在流行病学环境中钴胺素(维生素 B-12)状态的生物标志物:钴胺素、甲基丙二酸和全钴胺素 II 的背景、应用和性能特征的批判性概述。
Biomarkers of cobalamin (vitamin B-12) status in the epidemiologic setting: a critical overview of context, applications, and performance characteristics of cobalamin, methylmalonic acid, and holotranscobalamin II.
机构信息
Department of Medicine, New York Methodist Hospital, Brooklyn, NY 11215, USA.
出版信息
Am J Clin Nutr. 2011 Jul;94(1):348S-358S. doi: 10.3945/ajcn.111.013441. Epub 2011 May 18.
Cobalamin deficiency is relatively common, but the great majority of cases in epidemiologic surveys have subclinical cobalamin deficiency (SCCD), not classical clinical deficiency. Because SCCD has no known clinical expression, its diagnosis depends solely on biochemical biomarkers, whose optimal application becomes crucial yet remains unsettled. This review critically examines the current diagnostic concepts, tools, and interpretations. Their exploration begins with understanding that SCCD differs from clinical deficiency not just in degree of deficiency but in fundamental pathophysiology, causes, likelihood and rate of progression, and known health risks (the causation of which by SCCD awaits proof by randomized clinical trials). Conclusions from SCCD data, therefore, often may not apply to clinical deficiency and vice versa. Although many investigators view cobalamin testing as unreliable, cobalamin, like all diagnostic biomarkers, performs satisfactorily in clinical deficiency but less well in SCCD. The lack of a diagnostic gold standard limits the ability to weigh the performance characteristics of metabolic biomarkers such as methylmalonic acid (MMA) and holotranscobalamin II, whose specificities remain incompletely defined outside their relations to each other. Variable cutoff selections affect diagnostic conclusions heavily and need to be much better rationalized. The maximization of reliability and specificity of diagnosis is far more important today than the identification of ever-earlier stages of SCCD. The limitations of all current biomarkers make the combination of ≥2 test result abnormalities, such as cobalamin and MMA, the most reliable approach to diagnosing deficiency in the research setting; reliance on one test alone courts frequent misdiagnosis. Much work remains to be done.
钴胺素缺乏症较为常见,但在流行病学调查中,绝大多数病例为亚临床钴胺素缺乏症(SCCD),而非典型临床缺乏症。由于 SCCD 无明显临床症状,其诊断仅依赖于生化生物标志物,其最佳应用至关重要,但仍未得到解决。本文批判性地评估了当前的诊断概念、工具和解释。其探索始于了解到 SCCD 与临床缺乏症的区别不仅在于缺乏程度,还在于基本病理生理学、病因、可能性和进展速度,以及已知的健康风险(SCCD 导致这些风险的因果关系尚需通过随机临床试验证明)。因此,SCCD 数据的结论通常可能不适用于临床缺乏症,反之亦然。尽管许多研究人员认为钴胺素检测不可靠,但与所有诊断生物标志物一样,钴胺素在临床缺乏症中表现良好,但在 SCCD 中表现较差。缺乏诊断金标准限制了衡量代谢生物标志物(如甲基丙二酸(MMA)和全转钴胺素 II)性能特征的能力,其特异性在与彼此的关系之外仍未完全定义。可变的截止值选择严重影响诊断结论,需要进行更好的合理化。诊断的可靠性和特异性的最大化远比识别 SCCD 的更早阶段更为重要。所有当前生物标志物的局限性使得≥2 种测试结果异常(如钴胺素和 MMA)的组合成为研究环境中诊断缺乏症的最可靠方法;单独依赖一种测试容易导致频繁误诊。仍有许多工作要做。