Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
J Korean Med Sci. 2021 Apr 26;36(16):e105. doi: 10.3346/jkms.2021.36.e105.
Since September 2015, the initiation of antiviral therapy (AVT) for patients with chronic hepatitis B (CHB)-related cirrhosis has been reimbursed according to the revised Korean Association for the Study of Liver (KASL) guideline, if the patient had hepatitis B virus DNA level ≥ 2,000 IU/L, regardless of aminotransferase or alanine aminotransferase levels. This study investigated whether the KASL guideline implementation reduced the risk of CHB-related hepatocellular carcinoma (HCC) in patients with cirrhosis in South Korea.
A total of 429 patients with CHB-related cirrhosis who initiated AVT between 2014 and 2016 were recruited. The risk of HCC development was compared between patients who initiated AVT before and after September 2015 (pre-guideline [n = 196, 45.7%] vs. post-guideline implementation [n = 233, 54.3%]).
Univariate analysis showed that AVT initiation before guideline implementation, older age, male gender, and diabetes significantly predicted increased risk of HCC development (all < 0.05). Subsequent multivariate analysis showed that AVT initiation before guideline implementation (HR = 1.941), older age (HR = 5.762), male gender (HR = 2.555), and diabetes (HR = 1.568) independently predicted increased risk of HCC development (all < 0.05). Additionally, multivariate analysis showed that AVT initiation before guideline implementation (HR = 2.309), male gender (HR = 3.058), and lower platelet count (HR = 0.989) independently predicted mortality ( < 0.05). The cumulative incidences of HCC and mortality were significantly higher in patients who initiated AVT before guideline implementation than in those who initiated AVT after guideline implementation (all < 0.05, log-rank test).
The prognosis of patients with CHB-related cirrhosis who initiated AVT improved after guideline implementation according to the revised KASL guideline.
自 2015 年 9 月起，根据韩国肝病研究协会（KASL）修订后的指南，如果患者乙型肝炎病毒 DNA 水平≥2000IU/L，无论转氨酶或丙氨酸氨基转移酶水平如何，慢性乙型肝炎（CHB）相关肝硬化患者开始抗病毒治疗（AVT）均可获得报销。本研究旨在探讨 KASL 指南的实施是否降低了韩国 CHB 相关肝硬化患者发生肝癌（HCC）的风险。
共纳入 2014 年至 2016 年间开始 AVT 的 429 例 CHB 相关肝硬化患者。比较 2015 年 9 月前（指南前，n=196，45.7%）和指南实施后（n=233，54.3%）开始 AVT 的患者 HCC 发展风险。
单因素分析显示，指南实施前开始 AVT、年龄较大、男性和糖尿病显著增加 HCC 发展风险（均<0.05）。随后的多因素分析显示，指南实施前开始 AVT（HR=1.941）、年龄较大（HR=5.762）、男性（HR=2.555）和糖尿病（HR=1.568）均独立预测 HCC 发展风险增加（均<0.05）。此外，多因素分析显示，指南实施前开始 AVT（HR=2.309）、男性（HR=3.058）和较低的血小板计数（HR=0.989）均独立预测死亡率增加（均<0.05）。指南实施前开始 AVT 的患者 HCC 和死亡率的累积发生率明显高于指南实施后开始 AVT 的患者（均<0.05，对数秩检验）。
根据修订后的 KASL 指南，开始 AVT 的 CHB 相关肝硬化患者的预后在指南实施后得到改善。
