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替诺福韦酯富马酸二吡呋酯和恩替卡韦在肝移植患者中的肾脏安全性:一项全国性韩国注册研究。

Renal safety of tenofovir disoproxil fumarate and entecavir in liver transplant patients: a nationwide Korean registry study.

机构信息

Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.

Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

出版信息

Hepatol Int. 2022 Jun;16(3):537-544. doi: 10.1007/s12072-022-10320-z. Epub 2022 Apr 23.

Abstract

BACKGROUND AND AIMS

Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) have been recommended after liver transplantation to prevent recurrence of hepatitis B virus infection. Despite its proven efficacy, the renal safety of TDF has not been established in liver transplant recipients. We aimed to compare the effects of TDF and ETV on renal function in liver transplant recipients and to evaluate risk factors for renal dysfunction after liver transplantation.

METHODS

This is a retrospective, observational multicenter study of data from the Korean Organ Transplantation Registry. We included adults who underwent liver transplantation for hepatitis B virus-related complications from April 2014 to December 2017 and received TDF or ETV post-transplantation. Renal dysfunction was defined as an estimated glomerular filtration rate decline by at least 20% from baseline (1 month post-transplantation). Median duration of follow-up was 29 months (interquartile range 19-42).

RESULTS

A total of 804 liver transplant patients were included. The cumulative probability of renal dysfunction was significantly higher in the TDF group than in the ETV group. Multivariable analysis confirmed that TDF was independently associated with an increased risk of renal dysfunction (hazard ratio = 1.47, 95% confidence interval 1.12-1.92; p = 0.005). Independent risk factors for renal dysfunction included older age, worse baseline renal function, and low body mass index. Overall survival rate was significantly lower in patients with renal dysfunction than in those without.

CONCLUSIONS

In this nationwide study, the use of TDF was associated with an increased risk of renal dysfunction, when compared with ETV.

摘要

背景与目的

富马酸替诺福韦二吡呋酯(TDF)和恩替卡韦(ETV)已被推荐用于肝移植后,以预防乙型肝炎病毒感染的复发。尽管 TDF 已被证明具有疗效,但 TDF 在肝移植受者中的肾脏安全性尚未确定。我们旨在比较 TDF 和 ETV 对肝移植受者肾功能的影响,并评估肝移植后肾功能障碍的危险因素。

方法

这是一项来自韩国器官移植登记处的回顾性、观察性多中心研究。我们纳入了 2014 年 4 月至 2017 年 12 月期间因乙型肝炎病毒相关并发症而行肝移植的成年患者,且术后接受 TDF 或 ETV 治疗。肾功能障碍定义为肾小球滤过率基线(移植后 1 个月)下降至少 20%。中位随访时间为 29 个月(四分位距 19-42)。

结果

共纳入 804 例肝移植患者。TDF 组的肾功能障碍累积发生率明显高于 ETV 组。多变量分析证实 TDF 与肾功能障碍的风险增加独立相关(风险比 1.47,95%置信区间 1.12-1.92;p=0.005)。肾功能障碍的独立危险因素包括年龄较大、基线肾功能较差和低体重指数。肾功能障碍患者的总生存率明显低于无肾功能障碍患者。

结论

在这项全国性研究中,与 ETV 相比,使用 TDF 与肾功能障碍风险增加相关。

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