乙肝治疗患者的肝纤维化消退与肝脏相关事件减少相关。
Regression of Liver Fibrosis in Patients on Hepatitis B Therapy Is Associated With Decreased Liver-Related Events.
机构信息
Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Beijing, China.
Experimental and Translational Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
出版信息
Clin Gastroenterol Hepatol. 2024 Mar;22(3):591-601.e3. doi: 10.1016/j.cgh.2023.11.017. Epub 2023 Nov 30.
BACKGROUND & AIMS: Liver fibrosis in patients with chronic hepatitis B can regress with successful antiviral therapy. However, the long-term clinical benefits of fibrosis regression have not been fully elucidated. This study investigated the association between biopsy-proven fibrosis regression by predominantly progressive, indeterminate, and predominantly regressive (P-I-R) score and liver-related events (LREs) in chronic hepatitis B patients.
METHODS
Patients with on-treatment liver biopsy and significant fibrosis/cirrhosis (Ishak stage ≥3) were included in this analysis. Fibrosis regression was evaluated according to the P-I-R score of the Beijing Classification. LREs were defined as decompensations, hepatocellular carcinoma, liver transplantation, or death. The Cox proportional hazards model was used to determine associations of fibrosis regression with LREs.
RESULTS
A total of 733 patients with Ishak stages 3/4 (n = 456; 62.2%) and cirrhosis (Ishak stages 5/6; n = 277; 37.8%) by on-treatment liver biopsy were enrolled. According to the P-I-R score, fibrosis regression, indeterminate, and progression were observed in 314 (42.8%), 230 (31.4%), and 189 (25.8%) patients, respectively. The 7-year cumulative incidence of LREs was 4.1%, 8.7%, and 18.1% in regression, indeterminate, and progression, respectively (log-rank, P < .001). Compared with patients with fibrosis progression, those with fibrosis regression had a lower risk of LREs (adjusted hazard ratio, 0.40; 95% CI, 0.16-0.99; P = .047), followed by the indeterminate group (adjusted hazard ratio, 0.86; 95% CI, 0.40-1.85; P = .691). Notably, this favorable association also was observed in patients with cirrhosis or low platelet counts (<150 × 10/L).
CONCLUSIONS
Antiviral therapy-induced liver fibrosis regression assessed by P-I-R score is associated with reduced LREs. This shows the utility of histologic fibrosis regression assessed by on-treatment P-I-R score as a surrogate endpoint for clinical events in patients with hepatitis B virus-related fibrosis or early cirrhosis.
背景与目的
慢性乙型肝炎患者的肝纤维化可通过成功的抗病毒治疗得到逆转。然而，纤维化逆转的长期临床获益尚未完全阐明。本研究旨在探讨北京分类的主要进展型、不确定型和主要逆转型（P-I-R）评分所证实的肝纤维化逆转与慢性乙型肝炎患者的肝脏相关事件（LREs）之间的关联。
方法
本分析纳入了接受治疗的肝活检且存在显著纤维化/肝硬化（Ishak 分期≥3）的患者。根据北京分类的 P-I-R 评分评估纤维化的逆转情况。LREs 定义为失代偿、肝细胞癌、肝移植或死亡。采用 Cox 比例风险模型确定纤维化逆转与 LREs 的关联。
结果
共纳入 733 例接受治疗的肝活检中 Ishak 分期 3/4 期（n=456；62.2%）和肝硬化（Ishak 分期 5/6 期；n=277；37.8%）的患者。根据 P-I-R 评分，314 例（42.8%）、230 例（31.4%）和 189 例（25.8%）患者分别出现纤维化逆转、不确定和进展。在纤维化逆转、不确定和进展的患者中，7 年累积 LREs 发生率分别为 4.1%、8.7%和 18.1%（对数秩检验，P<0.001）。与纤维化进展的患者相比，纤维化逆转的患者 LREs 风险较低（调整后的危险比，0.40；95%CI，0.16-0.99；P=0.047），其次是不确定组（调整后的危险比，0.86；95%CI，0.40-1.85；P=0.691）。值得注意的是，这种有利的关联在肝硬化或血小板计数较低（<150×10/L）的患者中也观察到。
结论
P-I-R 评分评估的抗病毒治疗诱导的肝纤维化逆转与 LREs 减少相关。这表明，通过治疗中的 P-I-R 评分评估组织学纤维化逆转作为乙型肝炎病毒相关纤维化或早期肝硬化患者临床事件的替代终点是有用的。
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