慢性乙型肝炎从功能性治愈到个体化终点的循证演进过程

摘要/Abstract

摘要： 既往慢性乙型肝炎(CHB)的临床实践多以功能性治愈(HBsAg<0.05 IU/mL且HBV DNA不可测)作为最优治疗终点,但该固定标准忽视了患者基线特征与疾病状态的异质性,导致超90%患者被判定为治疗失败^[1]。研究表明,治疗前的基线qHBsAg水平显著影响治愈率(<100 IU/mL者约37.7%,>1 000 IU/mL者仅2.3%)^[2];同时,超敏HBsAg检测揭示了达到功能性治愈的患者仍存在残余抗原血症及血清学逆转的风险^[3]。此外,HBsAg转阴与肝细胞癌的风险下降无显著关联^[4]。为此,学界提出部分治愈(HBsAg<100 IU/mL伴HBV DNA不可测)的新评判标准作为中间终点,达到该标准者,其肝细胞癌年发病率(0.08%～0.09%)不高于功能性治愈者残余风险,却可将临床试验的有效应答率从<10%提升至30%～50%。本文基于多项研究数据,系统阐述了CHB从单一功能性治愈向多层级个体化评估体系的循证演进过程。

关键词: 慢性乙型肝炎, 功能性治愈, 部分治愈, 个体化终点, HBsAg, cccDNA

梁奕赞, 余姣, 冒慧, 万谟彬. 慢性乙型肝炎从功能性治愈到个体化终点的循证演进过程[J]. 肝脏, 2026, 31(8): 1061-1063.

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