Division of Hepatogastroenterology, Department of Internal Medicine, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan.
Department of Traditional Chinese Medicine, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan.
Sci Rep. 2021 Jan 14;11(1):1365. doi: 10.1038/s41598-020-80523-7.
It remains controversial whether entecavir (ETV) and tenofovir disoproxil fumarate (TDF) is associated with different clinical outcomes for chronic hepatitis B (CHB). This study aimed to compare the long-term risk of ETV versus TDF on hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) in CHB patients from a large multi-institutional database in Taiwan. From 2011 to 2018, a total of 21,222 CHB patients receiving ETV or TDF were screened for eligibility. Patients with coinfection, preexisting cancer and less than 6 months of follow-up were excluded. Finally, 7248 patients (5348 and 1900 in the ETV and TDF groups, respectively) were linked to the National Cancer Registry database for the development of HCC or ICC. Propensity score matching (PSM) (2:1) analysis was used to adjust for baseline differences. The HCC incidence between two groups was not different in the entire population (hazard ratio [HR] 0.82; 95% confidence interval [CI] 0.66-1.02, p = 0.078) and in the PSM population (HR 0.83; 95% CI 0.65-1.06, p = 0.129). Among decompensated cirrhotic patients, a lower risk of HCC was observed in TDF group than in ETV group (HR 0.54; 95% CI 0.30-0.98, p = 0.043, PSM model). There were no differences between ETV and TDF groups in the ICC incidence (HR 1.84; 95% CI 0.54-6.29, p = 0.330 in the entire population and HR 1.04; 95% CI 0.31-3.52, p = 0.954 in the PSM population, respectively). In conclusion, treatment with ETV and TDF showed a comparable long-term risk of HCC and ICC in CHB patients.
对于恩替卡韦（ETV）和富马酸替诺福韦二吡呋酯（TDF）是否会对慢性乙型肝炎（CHB）患者的临床结局产生不同影响，目前仍存在争议。本研究旨在通过台湾一家大型多机构数据库，比较 ETV 和 TDF 治疗 CHB 患者的长期肝细胞癌（HCC）和肝内胆管细胞癌（ICC）风险。2011 年至 2018 年，共筛选了 21222 例接受 ETV 或 TDF 治疗的 CHB 患者，以确定其是否符合入选条件。排除合并感染、合并癌症和随访时间少于 6 个月的患者。最终，将 7248 例患者（ETV 组 5348 例，TDF 组 1900 例）与国家癌症登记数据库相链接，以确定 HCC 或 ICC 的发病情况。采用倾向评分匹配（PSM）（2:1）分析来调整基线差异。两组患者的 HCC 发生率在全人群中无差异（风险比 [HR] 0.82；95%置信区间 [CI] 0.66-1.02，p=0.078），在 PSM 人群中也无差异（HR 0.83；95%CI 0.65-1.06，p=0.129）。在失代偿性肝硬化患者中，TDF 组 HCC 风险低于 ETV 组（HR 0.54；95%CI 0.30-0.98，p=0.043，PSM 模型）。两组患者 ICC 发生率无差异（全人群中 HR 1.84；95%CI 0.54-6.29，p=0.330，PSM 人群中 HR 1.04；95%CI 0.31-3.52，p=0.954）。总之，ETV 和 TDF 治疗 CHB 患者的 HCC 和 ICC 长期风险相当。
