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巴利昔单抗和 ATG 诱导后使用激素与停用激素对肾移植结局的比较分析:UNOS 数据库研究。

A comparative analysis of kidney allograft outcomes in steroid use versus steroid discontinuation after basiliximab and ATG induction: A UNOS database study.

出版信息

Clin Nephrol. 2024 Jul;102:39-50. doi: 10.5414/CN111033.

DOI:10.5414/CN111033
PMID:38699983
Abstract

BACKGROUND AND OBJECTIVES

The relative safety and efficacy of early steroid withdrawal in kidney transplant patients after basiliximab compared to anti-thymocyte globulin (ATG) induction therapy is unknown. We aimed to compare kidney allograft outcomes in steroid use versus steroid discontinuation after basiliximab and ATG induction from the United Network for Organ Sharing (UNOS) database.

MATERIALS AND METHODS

We conducted a retrospective cohort analysis of the UNOS database and included first kidney transplant recipients who received ATG or basiliximab induction therapy. We compared graft and patient outcomes in those who received steroid maintenance and those who were discharged off steroids.

RESULTS

Of 106,061 patients, 25,344 (86.7%) received basiliximab induction and were maintained on steroids (B-Sm), and 3,880 (13.3%) were on a steroid-free regimen (B-Sf). Graft failure rate was significantly higher in the B-Sf compared to B-Sm at 1-year (4.1 vs. 1.8%, p < 0.001), 3-year (6.0 vs. 4.3%, p < 0.001) and 5-year follow-up (7.7 vs. 6.4%, p = 0.0004). The mortality rate was significantly higher in B-Sf at 1-year (3.3 vs. 2.4%, p = 0.0005), 3-year (7.6 vs. 5.5%, p < 0.001) and 5-year follow-up (11.5 vs. 8.8%, p < 0.001) when compared to the B-Sm. 76,837 recipients received ATG induction therapy, 51,745 (72.4%) were on steroid maintenance therapy (A-Sm) and 25,092 (32.6%) were on a steroid-free regimen (A-Sf). The graft failure rate was significantly higher in A-Sf compared to A-Sm at 1-year follow-up (2.6 vs. 2.3%, p = 0.0006), however, there was no difference at 3-year (5.0 vs. 5.0%, p = 0.53) or 5-year follow-up (7.2 vs. 8.1%, p = 0.17). There was no difference in mortality rates between A-Sf vs. A-Sm at 1 year (2.5 vs. 2.4%, p = 0.98) and at 3 years (5.5 vs. 5.4%, p = 0.45), respectively.

CONCLUSION

Patients who were maintained on steroids after basiliximab induction had better 5-year allograft survival and patient survival compared to those who were not maintained on steroids. However, steroid maintenance conferred no additional benefit after ATG induction and was associated with higher mortality.

摘要

背景与目的

与抗胸腺细胞球蛋白(ATG)诱导疗法相比,巴利昔单抗诱导治疗后早期停用类固醇在肾移植患者中的相对安全性和疗效尚不清楚。我们旨在从美国器官共享网络(UNOS)数据库比较巴利昔单抗和 ATG 诱导后使用和停用类固醇的肾移植受者的移植物结局。

材料与方法

我们对 UNOS 数据库进行了回顾性队列分析,纳入了接受 ATG 或巴利昔单抗诱导治疗的首次肾移植受者。我们比较了接受类固醇维持治疗和停用类固醇的患者的移植物和患者结局。

结果

在 106061 名患者中,25344 名(86.7%)接受了巴利昔单抗诱导并接受类固醇维持治疗(B-Sm),3880 名(13.3%)接受了无类固醇治疗方案(B-Sf)。在 1 年、3 年和 5 年随访时,B-Sf 的移植物失效率明显高于 B-Sm(分别为 4.1% vs. 1.8%,p<0.001;6.0% vs. 4.3%,p<0.001;7.7% vs. 6.4%,p=0.0004)。B-Sf 的死亡率在 1 年、3 年和 5 年随访时明显高于 B-Sm(分别为 3.3% vs. 2.4%,p=0.0005;7.6% vs. 5.5%,p<0.001;11.5% vs. 8.8%,p<0.001)。76837 名受者接受了 ATG 诱导治疗,51745 名(72.4%)接受了类固醇维持治疗(A-Sm),25092 名(32.6%)接受了无类固醇治疗方案(A-Sf)。在 1 年随访时,A-Sf 的移植物失效率明显高于 A-Sm(2.6% vs. 2.3%,p=0.0006),但在 3 年和 5 年随访时无差异(分别为 5.0% vs. 5.0%,p=0.53;7.2% vs. 8.1%,p=0.17)。A-Sf 与 A-Sm 的死亡率在 1 年(2.5% vs. 2.4%,p=0.98)和 3 年(5.5% vs. 5.4%,p=0.45)时无差异。

结论

与未接受类固醇维持治疗的患者相比,巴利昔单抗诱导后接受类固醇维持治疗的患者 5 年移植物存活率和患者存活率更高。然而,ATG 诱导后使用类固醇维持治疗并没有带来额外的益处,反而与更高的死亡率相关。

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