Department of Surgery, Brody School of Medicine at East Carolina University, Greenville, North Carolina, USA.
East Carolina University Health System, Greenville, North Carolina, USA.
Clin Transplant. 2024 Mar;38(3):e15268. doi: 10.1111/ctr.15268.
The purpose of this study was to compare early outcomes of de novo LCPT (once-daily extended-release tacrolimus) to IR TAC (twice-daily immediate-release tacrolimus) in a predominantly African American (AA) adult kidney transplant population.
This is a single center, retrospective cohort study. Patients were divided into two cohorts: IR TAC (administered between January 1, 2017, and January 31, 2019) and LCPT (administered between February 1, 2019, and May 31, 2020). Primary endpoints were changes in tacrolimus trough levels (ng/mL) and estimated glomerular filtration rate up to 12 months post-transplantation. Clinical endpoints included graft survival, delayed graft function, biopsy-proven rejection, CMV viremia, and BK. A propensity score weighted generalized linear mixed effects model was used for analysis.
The rate of change in tacrolimus levels was significantly higher in the LCPT cohort compared to the IR TAC cohort at 14 days post-discharge (.2455 ng/mL per day vs. .1073 ng/mL, respectively; p < .001). Subsequently, the LCPT cohort had a slightly higher rate of decline (-.015 ng/mL per day vs. -.010 ng/mL with IR TAC; p = .0894) up to 12 months post-discharge. Although eGFR was similar between the two cohorts at 12 months post-transplant, the rate of increase was slower in the LCPT cohort (.1371 mL/min per day vs. .1852 mL/min per day, p = .0314). No significant differences were found in graft survival, DGF, BPAR, CMV, or BK infection.
This study demonstrates that despite higher early trough levels with immediate post-transplant LCPT use, clinical outcomes are comparable to IR TAC at one-year post-transplant. Notably, LCPT use does not increase the incidence of DGF and that this formulation of CNI can be used as first line therapy post-transplant.
本研究旨在比较新诊断的 LCPT（每日一次的延长释放他克莫司）与 IR TAC（每日两次的即时释放他克莫司）在以非裔美国人（AA）为主的成年肾移植患者中的早期结果。
这是一项单中心回顾性队列研究。患者分为两个队列：IR TAC（于 2017 年 1 月 1 日至 2019 年 1 月 31 日期间使用）和 LCPT（于 2019 年 2 月 1 日至 2020 年 5 月 31 日期间使用）。主要终点是移植后 12 个月内他克莫司谷浓度（ng/mL）和估算肾小球滤过率的变化。临床终点包括移植物存活率、延迟移植物功能、活检证实的排斥反应、CMV 病毒血症和 BK。采用倾向评分加权广义线性混合效应模型进行分析。
与 IR TAC 队列相比，LCPT 队列在出院后 14 天的他克莫司水平变化率明显更高（分别为每天 0.2455ng/mL 和 0.1073ng/mL；p<0.001）。随后，LCPT 队列在出院后 12 个月的下降速度略快（每天-0.015ng/mL 与 IR TAC 相比-0.010ng/mL；p=0.0894）。尽管两个队列在移植后 12 个月时的 eGFR 相似，但 LCPT 队列的增长率较慢（每天 0.1371mL/min 与每天 0.1852mL/min；p=0.0314）。在移植物存活率、DGF、BPAR、CMV 或 BK 感染方面，两组间无显著差异。
本研究表明，尽管 LCPT 在移植后立即使用时早期谷浓度较高，但在移植后 1 年的临床结果与 IR TAC 相当。值得注意的是，LCPT 的使用并不会增加 DGF 的发生率，并且这种 CNI 制剂可作为移植后的一线治疗药物。
