肾移植术后发生移植后新发糖尿病风险患者的早期类固醇撤药。

Early Steroid Withdrawal After Kidney Transplantation in Patients at Risk for New-Onset Diabetes After Transplantation.

机构信息

Service de Néphrologie, Hémodialyse, Aphérèses et Transplantation Rénale, CHU Grenoble-Alpes, Grenoble, France.

Service de Néphrologie, Hémodialyse, Aphérèses et Transplantation Rénale, CHU Grenoble-Alpes, Grenoble, France; Université Grenoble Alpes, Grenoble, France.

出版信息

Transplant Proc. 2021 Sep;53(7):2216-2226. doi: 10.1016/j.transproceed.2021.07.047. Epub 2021 Aug 26.

DOI:10.1016/j.transproceed.2021.07.047

PMID:34454728

Abstract

BACKGROUND

New-onset diabetes after transplantation (NODAT) is a serious complication after kidney transplantation because of worse graft survival and increased risk of cardiovascular events. It is partly induced by immunosuppressive therapies such as corticosteroids. This study aimed to assess whether early corticosteroid withdrawal on day 4 (early steroid withdrawal [ESW] group) could prevent the development of NODAT within 2 years posttransplantation while maintaining good graft and patient survival rates.

METHODS

This was an observational, single-center, retrospective study. All patients received an induction therapy of antithymocyte globulin or basiliximab and maintenance therapy of tacrolimus/mycophenolate mofetil/corticosteroids. Patients were either weaned off corticosteroids on day 4 (ESW group) or were maintained on corticosteroids for at least 3 months (standard group). NODAT was defined as the initiation of any oral hypoglycemic agent or insulin at 3 months and up to 2 years posttransplantation in previously nondiabetic recipients.

RESULTS

Between January, 1, 2010, and December 14, 2014, 492 recipients were included in this study; 88 received the ESW strategy, and 404 received the standard strategy. Age and body mass index (BMI) were significantly higher in the ESW group. The incidence of NODAT was 36.8% in the ESW group and 8.8% in the standard group (odds ratio [OR], 47.5; P < .001). Compared with a matched sample from the standard group that had the same probability to benefit from ESW at baseline, ESW was still associated with a significantly increased risk of NODAT (OR, 4.41; P = .018). Among recipients with a BMI >25 kg/m, the ESW strategy significantly decreased the risk of NODAT compared with the standard strategy (OR, 0.07; P = .013). Safety endpoints (eg, acute rejection, de novo-specific antibodies, graft function/survival) did not differ between groups.

CONCLUSION

Despite a reassuring safety profile, ESW on day 4 after kidney transplantation only had a marginal effect on the incidence of NODAT.

摘要

背景

移植后新发糖尿病（NODAT）是肾移植后的一种严重并发症，因为它会导致移植物存活率降低和心血管事件风险增加。它部分是由免疫抑制治疗引起的，如皮质类固醇。本研究旨在评估在移植后 2 年内，第 4 天（早期撤药[ESW]组）早期撤去皮质类固醇是否可以预防 NODAT 的发生，同时保持良好的移植物和患者存活率。

方法

这是一项观察性、单中心、回顾性研究。所有患者均接受抗胸腺细胞球蛋白或巴利昔单抗诱导治疗和他克莫司/霉酚酸酯/皮质类固醇维持治疗。患者要么在第 4 天撤去皮质类固醇（ESW 组），要么至少维持皮质类固醇治疗 3 个月（标准组）。NODAT 的定义为在先前无糖尿病的受者中，在移植后 3 个月至 2 年内开始使用任何口服降糖药或胰岛素。

结果

2010 年 1 月 1 日至 2014 年 12 月 14 日期间，共纳入 492 例受者；88 例接受 ESW 治疗，404 例接受标准治疗。ESW 组的年龄和体重指数（BMI）显著高于标准组。ESW 组 NODAT 的发生率为 36.8%，标准组为 8.8%（优势比[OR]，47.5；P<.001）。与标准组中基线时同样有机会从 ESW 中获益的匹配样本相比，ESW 仍与 NODAT 的风险显著增加相关（OR，4.41；P=.018）。在 BMI>25 kg/m2的受者中，与标准方案相比，ESW 方案显著降低了 NODAT 的风险（OR，0.07；P=.013）。两组间的安全性终点（如急性排斥反应、新出现的特异性抗体、移植物功能/存活率）无差异。