低剂量胸腺球蛋白与巴利昔单抗诱导治疗低危活体亲属供肾移植受者：3 年随访研究。

Low-Dose Thymoglobulin versus Basiliximab Induction Therapy in Low-Risk Living Related Kidney Transplant Recipients: Three-Year Follow-Up Study.

机构信息

Department of Organ Transplantation, Unidad Médica de Alta Especialidad, Hospital de Especialidades No. 14, Centro Médico Nacional Adolfo Ruiz Cortines, Instituto Mexicano del Seguro Social, Veracruz, Ver. Mexico; Department of Research, Unidad Médica de Alta Especialidad, Hospital de Especialidades No. 14, Centro Médico Nacional Adolfo Ruiz Cortines, Instituto Mexicano del Seguro Social, Veracruz, Ver. Mexico.

出版信息

Arch Med Res. 2024 Sep;55(6):103047. doi: 10.1016/j.arcmed.2024.103047. Epub 2024 Jul 29.

DOI:10.1016/j.arcmed.2024.103047

PMID:39079480

Abstract

BACKGROUND

The optimal dose of rabbit anti-thymocyte globulin (r-ATG) in renal transplantation is still under debate. We previously reported that a low-dose r-ATG induction of 3 mg/kg can be used safely and effectively in low-risk kidney transplants with good results in the first year after transplantation compared to basiliximab induction.

AIMS

The purpose of this study is to evaluate the long-term impact of this trial of low-dose r-ATG versus basiliximab on post-transplant outcomes (patient and graft survival, biopsy-proven acute rejection incidence [BPAR], infectious complications, and side effects).

METHODS

Observational study (three-year follow-up) of a 12-month single-center, open-label RCT in de novo kidney allograft recipients assigned to receive either thymoglobulin or basiliximab before transplantation.

RESULTS

Patients in the basiliximab group (BG) underwent more kidney transplant biopsies than patients in the low-dose r-ATG group (TG) (50 vs. 31.8%, p = 0.07). Although the 12-month cumulative incidence of BPAR was lower in BG, by the end of the three-year follow-up period this incidence was higher (22%) than in the low-dose TG (15%) (p = ns). Steroids were withdrawn more frequently in the TG group and sirolimus was most frequently indicated. Graft function and graft survival were higher in the low-dose TG than in the BG at three-year follow-up but not statistically significant. Patient survival was similar between groups (>90%).

CONCLUSIONS

These three-year follow-up data confirm the efficacy and favorable safety aspects of the low-dose r-ATG (3 mg/kg) in low-risk kidney transplantation.

摘要

背景

兔抗胸腺细胞球蛋白（r-ATG）在肾移植中的最佳剂量仍存在争议。我们之前报道过，与巴利昔单抗诱导相比，低剂量 r-ATG（3mg/kg）诱导在低危肾移植中是安全有效的，并且在移植后第一年的结果较好。

目的

本研究旨在评估低剂量 r-ATG 与巴利昔单抗在移植后结局（患者和移植物存活率、活检证实的急性排斥发生率[BPAR]、感染并发症和副作用）方面的长期影响。

方法

对单中心、开放标签 RCT 的 12 个月随访期进行观察性研究，该 RCT 招募了新接受肾同种异体移植的患者，随机分配接受胸腺球蛋白或巴利昔单抗治疗。

结果

与低剂量 r-ATG 组（TG）相比，巴利昔单抗组（BG）的患者接受的肾移植活检更多（50 次比 31.8%，p = 0.07）。尽管 BG 中 12 个月累积 BPAR 发生率较低，但在 3 年随访结束时，这一发生率更高（22%），高于低剂量 TG（15%）（p = 无统计学意义）。TG 组更频繁地停用皮质类固醇，并且最常使用西罗莫司。在 3 年随访时，低剂量 TG 组的移植物功能和存活率均高于 BG，但无统计学意义。两组患者存活率均相似（>90%）。