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确定患有慢性肝病和肝细胞癌的患者的α-fetoprotein参考范围

Anton Kalyuzhnyy¹, Hidenori Toyoda², Philip J Johnson³

¹Computational Biology Facility, University of Liverpool, Liverpool, UK.

HPB : the official journal of the International Hepato Pancreato Biliary Association

|September 26, 2025

概括

新的α-fetoprotein (AFP) 参考范围可以准确诊断肝细胞癌 (HCC). 这项研究确定了HCC的40 ng/mL值,并描述了AFP负的HCC,改善了肝癌的诊断和理解.

科学领域:

肝病学肝病学是一种肝病学.
在瘤学瘤学.
生物标志物发现发现

背景情况:

阿尔法-胎蛋白 (AFP) 是肝细胞癌 (HCC) 的关键生物标志物,但目前的诊断值是任意的,缺乏定义的参考范围.
在HCC诊断中的一个重大挑战是存在AFP阴性瘤,这些瘤不合成AFP,使其的表征和检测变得复杂.
基于AFP水平的HCC现有的诊断标准尚未确定,导致潜在的不准确性和错过诊断.

研究的目的:

在慢性肝病 (CLD) 患者和健康人群中确定血清AFP的最终参考范围.
为了确定一个准确的AFP值,以诊断HCC与最小的错误阳性.
描述AFP阴性HCC患者的子集,并调查其临床结果.

主要方法:

分析了来自日本和英国的4500多名患有和没有HCC的患者的AFP分布,以及一个健康的对照组.
对非HCC CLD患者和健康个体的上方AFP极限的统计确定,以确定参考范围.
根据健康人群的确定的AFP极限和生存率的比较,将HCC患者归类为AFP阴性.

主要成果:

在没有HCC的CLD患者中确定了40 ng/mL的上限AFP,使得在这个水平以上的HCC诊断能够准确,假阳性率低.
在健康人群中,AFP的上限为5 ng/mL,定义了AFP阴性HCC.
大约15%的HCC患者被归类为AFP阴性;与AFP阳性HCC患者相比,这些患者在诊断后的生存率显著改善,无论治疗方法如何.

结论:

该研究成功建立了精确的AFP参考范围,作为HCC诊断的准确切线.
定义的范围有助于识别AFP阴性HCC病例,这是一个以前具有挑战性的诊断组.
这些发现增强了AFP在HCC的诊断效用,并为AFP阴性HCC的独特特征和预后提供了洞察力.

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