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替诺福韦与恩替卡韦治疗乙型肝炎病毒相关肝细胞癌切除术后复发的比较。

Tenofovir Versus Entecavir on Recurrence of Hepatitis B Virus-Related Hepatocellular Carcinoma After Surgical Resection.

机构信息

Department of GastroenterologyLiver CenterAsan Medical CenterUniversity of Ulsan College of MedicineSeoulRepublic of Korea.

Department of Internal MedicineAsan Medical CenterUniversity of Ulsan College of MedicineSeoulRepublic of Korea.

出版信息

Hepatology. 2021 Feb;73(2):661-673. doi: 10.1002/hep.31289. Epub 2020 Nov 2.

Abstract

BACKGROUND AND AIMS

Studies have suggested that tenofovir disoproxil fumarate (TDF) treatment is associated with a significantly lower risk of hepatocellular carcinoma (HCC) occurrence when compared with entecavir (ETV) therapy in patients with chronic hepatitis B. We aimed to compare HCC recurrence and survival of patients treated with TDF or ETV after surgical resection for hepatitis B virus (HBV)-related HCC.

APPROACH AND RESULTS

This historical cohort study included 1,695 consecutive patients treated with ETV (n = 813) or TDF (n = 882) after curative-intent hepatectomy for HBV-related HCC of Barcelona Clinic Liver Cancer stage 0 or A in Korea between 2010 and 2018. HCC recurrence and overall survival of patients were compared between ETV and TDF groups by propensity score-matched and multivariable-adjusted Cox regression analyses from the date of hepatectomy for HCC. The mean age of the study patients was 54.8 years, and 1,294 patients (76.3%) were male. During the median follow-up duration of 37.6 months with continued ETV or TDF therapy, 561 (33.1%) patients developed HCC recurrence, 144 (8.4%) died, and 22 (1.3%) received liver transplant. Compared with ETV, TDF therapy was associated with significantly higher recurrence-free (P = 0.02) and overall survival (P = 0.03) rates by propensity score-matched analysis. By multivariable-adjusted analysis, the TDF group was associated with significantly lower rates of HCC recurrence (hazard ratio [HR], 0.82; 95% confidence interval, 0.68-0.98; P = 0.03), and death or transplantation (HR, 0.62; 95% confidence interval, 0.44-0.88; P = 0.01). TDF therapy was an independent protective factor for both early (<2 years; HR, 0.79; P = 0.03) and late (≥2 years; HR, 0.68; P = 0.03) postoperative HCC recurrence.

CONCLUSIONS

Among patients who underwent curative hepatectomy for HBV-related HCC, TDF therapy was associated with a significantly lower risk of HCC recurrence and better overall patient survival compared with ETV therapy.

摘要

背景与目的

研究表明,与恩替卡韦(ETV)治疗相比,替诺福韦二吡呋酯(TDF)治疗在慢性乙型肝炎(HBV)患者中发生肝细胞癌(HCC)的风险显著降低。我们旨在比较 TDF 或 ETV 治疗后接受手术切除的乙型肝炎病毒(HBV)相关 HCC 患者的 HCC 复发和生存情况。

方法和结果

本历史队列研究纳入了 2010 年至 2018 年间在韩国接受巴塞罗那临床肝癌分期 0 或 A 的 HBV 相关 HCC 根治性肝切除术的 1695 例连续患者,分别接受 ETV(n=813)或 TDF(n=882)治疗。通过从 HCC 肝切除日期开始的倾向评分匹配和多变量调整 Cox 回归分析,比较 ETV 和 TDF 组患者的 HCC 复发和总体生存情况。研究患者的平均年龄为 54.8 岁,1294 例(76.3%)为男性。在中位随访 37.6 个月期间,持续接受 ETV 或 TDF 治疗,561 例(33.1%)患者发生 HCC 复发,144 例(8.4%)死亡,22 例(1.3%)接受肝移植。与 ETV 相比,TDF 治疗的无复发生存(P=0.02)和总体生存(P=0.03)率通过倾向评分匹配分析显著更高。通过多变量调整分析,TDF 组 HCC 复发(风险比 [HR],0.82;95%置信区间,0.68-0.98;P=0.03)和死亡或移植(HR,0.62;95%置信区间,0.44-0.88;P=0.01)的发生率显著较低。TDF 治疗是早期(<2 年;HR,0.79;P=0.03)和晚期(≥2 年;HR,0.68;P=0.03)术后 HCC 复发的独立保护因素。

结论

在接受 HBV 相关 HCC 根治性肝切除术的患者中,与 ETV 治疗相比,TDF 治疗 HCC 复发风险显著降低,总体患者生存情况更好。

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