Kim Jongman, Joh Jae-Won, Lee Kwang-Woong, Choi Dong Lak, Wang Hee-Jung
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
Ann Hepatobiliary Pancreat Surg. 2024 May 31;28(2):238-247. doi: 10.14701/ahbps.23-129. Epub 2024 Mar 15.
BACKGROUNDS/AIMS: Prolonged use of steroids after liver transplantation (LT) significantly increases the risk of diabetes or cardiovascular disease, which can adversely affect patient outcomes. Our study evaluated the effectiveness and safety of early steroid withdrawal within the first year following LT.
This study was conducted as an open-label, multicenter, randomized controlled trial. Liver transplant recipients were randomly assigned to one of the following two groups: Group 1, in which steroids were withdrawn two weeks posttransplantation, and Group 2, in which steroids were withdrawn three months posttransplantation. This study included participants aged 20 to 70 years who were scheduled to undergo a single-organ liver transplant from a living or deceased donor at one of the four participating centers.
Between November 2012 and August 2020, 115 patients were selected and randomized into two groups, with 60 in Group 1 and 55 in Group 2. The incidence of new-onset diabetes after transplantation (NODAT) was notably higher in Group 1 (32.4%) than in Group 2 (10.0%) in the per-protocol set. Although biopsy-proven acute rejection, graft failure, and mortality did not occur, the median tacrolimus trough level/dose/weight in Group 1 exceeded that in Group 2. No significant differences in safety parameters, such as infection and recurrence of hepatocellular carcinoma, were observed between the two groups.
The present study did not find a significant reduction in the incidence of NODAT in the early steroid withdrawal group. Our study suggests that steroid withdrawal three months posttransplantation is a standard and safe immunosuppressive strategy for LT patients.
背景/目的：肝移植（LT）后长期使用类固醇会显著增加糖尿病或心血管疾病的风险，这可能对患者预后产生不利影响。我们的研究评估了LT后第一年内早期停用类固醇的有效性和安全性。
本研究作为一项开放标签、多中心、随机对照试验进行。肝移植受者被随机分为以下两组之一：第1组，移植后两周停用类固醇；第2组，移植后三个月停用类固醇。本研究纳入了年龄在20至70岁之间、计划在四个参与中心之一接受来自活体或已故供体的单器官肝移植的参与者。
在2012年11月至2020年8月期间，选择了115例患者并随机分为两组，第1组60例，第2组55例。在符合方案集中，第1组移植后新发糖尿病（NODAT）的发生率（32.4%）明显高于第2组（10.0%）。虽然未发生经活检证实的急性排斥反应、移植物衰竭和死亡，但第1组他克莫司谷浓度/剂量/体重的中位数超过了第2组。两组在感染和肝细胞癌复发等安全参数方面未观察到显著差异。
本研究未发现早期停用类固醇组的NODAT发生率有显著降低。我们的研究表明，移植后三个月停用类固醇是LT患者的一种标准且安全的免疫抑制策略。
