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中华临床实验室管理电子杂志 ›› 2026, Vol. 14 ›› Issue (02) : 157 -165. doi: 10.3877/cma.j.issn.2095-5820.2026.02.010

综述

慢性乙型肝炎实验室标志物：循证依据、临床应用及管理策略
欧国敏1,2, 欧启水1,2,†()   
  1. 1　350005　福建福州，福建医科大学附属第一医院检验科，福建省检验医学重点实验室
    2　350212　福建福州，福建医科大学附属第一医院滨海院区国家区域医疗中心检验科
  • 收稿日期:2026-03-23 出版日期:2026-05-28
  • 通信作者: 欧启水
  • 基金资助:
    国家自然科学基金(82372316)

Laboratory biomarkers in chronic hepatitis B: Evidence base, clinical applications, and management strategies

Guomin Ou1,2, Qishui Ou1,2,†()   

  1. 1 Department of Laboratory Medicine, the First Affiliated Hospital of Fujian Medical University, Fujian Key Laboratory of Laboratory Medicine, 350005 Fuzhou Fujian, China
    2 Department of Laboratory Medicine, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou Fujian 350212, China
  • Received:2026-03-23 Published:2026-05-28
  • Corresponding author: Qishui Ou
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欧国敏, 欧启水. 慢性乙型肝炎实验室标志物：循证依据、临床应用及管理策略[J/OL]. 中华临床实验室管理电子杂志, 2026, 14(02): 157-165.

Guomin Ou, Qishui Ou. Laboratory biomarkers in chronic hepatitis B: Evidence base, clinical applications, and management strategies[J/OL]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2026, 14(02): 157-165.

慢性乙型肝炎（CHB）长期管理涉及筛查、诊断、疾病分期、抗病毒治疗监测、停药与复发风险评估以及肝硬化和肝细胞癌监测等多个环节。实验室标志物是CHB临床评估和决策的核心依据。随着乙型肝炎病毒基础研究和检测技术的发展，CHB实验室标志物已由传统血清学和病毒学指标，逐步扩展至反映病毒转录活性、抗原表达特征及病毒储存库状态的新型指标。在提高CHB诊断率和治疗率仍是基本目标的同时，功能性治愈作为重要治疗目标，也进一步提升了对残余病毒活性评估、停药风险分层及长期随访检测策略的需求。本文结合国内外指南及近年来研究进展，综述CHB经典和新型实验室标志物的循证依据与临床应用特点，并讨论触发检测和检验项目利用管理在CHB临床路径优化中的作用。总体而言，CHB实验室检测的优化不在于单纯增加项目，而在于围绕具体临床问题合理整合不同层次标志物，以提高诊疗效率、减少不必要检测，并更好地服务于CHB分层管理、长期随访及功能性治愈评估。

关键词: 慢性乙型肝炎, 实验室标志物, 循证依据, 临床应用, 功能性治愈

The long-term management of chronic hepatitis B (CHB) involves multiple steps, including screening, diagnosis, disease staging, monitoring of antiviral therapy, assessment of treatment discontinuation and risk of relapse, and surveillance for cirrhosis and hepatocellular carcinoma. Laboratory biomarkers are central to clinical evaluation and decision-making in CHB. With advances in hepatitis B virus (HBV) research and diagnostic technologies, laboratory biomarkers for CHB have evolved from conventional serologic and virologic markers to newer markers that reflect viral transcriptional activity, antigen expression characteristics, and the status of the viral reservoir. While improving diagnosis and treatment rates remains a fundamental goal in CHB care, the recognition of functional cure as an important therapeutic endpoint has further increased the need for biomarkers that can assess residual viral activity, stratify relapse risk after treatment withdrawal, and guide long-term follow-up strategies. In this review, we summarize the evidence base and clinical application characteristics of conventional and novel laboratory biomarkers in CHB, and further discuss the roles of reflex testing and laboratory test utilization management in optimizing clinical pathways for CHB. Overall, the optimization of laboratory testing in CHB should not depend on simply increasing the number of assays, but rather on the rational integration of biomarkers according to specific clinical questions, so as to improve diagnostic and management efficiency, reduce unnecessary testing, and better support stratified management, long-term follow-up, and the assessment of functional cure.

Key words: chronic hepatitis B, laboratory biomarkers, evidence base, clinical applications, functional cure
表1 新型标志物在CHB中的适用情境及局限性
新型标志物 适用情境 局限性
HBV RNA NAs治疗后 HBV DNA 已转阴患者的残余病毒转录活性评估；停药复发风险判断；新药研究中的疗效观察。 检测方法和阈值尚未完全统一，平台间一致性和标准化水平仍需提高。
HBcrAg HBV DNA阴性后的残余病毒活性评估；停药复发风险分层；长期疾病活动或肝癌风险评估。 不同地区可及性差异较大，检测阈值和临床判定标准尚未完全统一；在中国常规临床应用仍受限制。
超敏HBsAg 隐匿感染、低病毒血症、再激活早期识别以及功能性治愈后的微量残留监测。 不同检测平台间可比性有限，目前尚不适合作为常规HBsAg 的普遍替代方案。
HBsAg亚组分 鉴别非活动期HBV感染；预测CHB患者HBsAg消失；治疗过程中MHBs升高可能与肝细胞癌有关。 主要用于科研，尚缺乏统一检测体系、参考范围和临床应用标准。
肝组织cccDNA 病毒持续感染机制研究；新药临床试验；功能性治愈研究；复杂病例深入分析。 需获取肝组织，具有侵入性；取材异质性；检测前处理标准化不足等；尚不适合作为常规临床监测指标。
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