高他克莫司变异性成人肾移植受者由每日两次普通制剂他克莫司转换为每日一次 LCP-他克莫司的影响。

Impact of converting adult kidney transplant recipients with high tacrolimus variability from twice daily immediate release tacrolimus to once daily LCP-Tacrolimus.

机构信息

Department of Surgery, Division of Transplant Surgery, MUSC, Charleston, South Carolina, USA.

Department of Pharmacy Services, MUSC, Charleston, South Carolina, USA.

出版信息

Clin Transplant. 2023 May;37(5):e14941. doi: 10.1111/ctr.14941. Epub 2023 Feb 27.

DOI:10.1111/ctr.14941

PMID:36809653

Abstract

BACKGROUND

The influence of converting to once daily, extended-release LCP-Tacrolimus (Tac) for those with high tacrolimus variability in kidney transplant recipients (KTRs) is not well-studied.

METHODS

Single-center, retrospective cohort study of adult KTRs converted from Tac immediate release to LCP-Tac 1-2 years post-transplant. Primary measures were Tac variability, using the coefficient of variation (CV) and time in therapeutic range (TTR), as well as clinical outcomes (rejection, infections, graft loss, death).

RESULTS

A total of 193 KTRs included with a follow-up of 3.2 ± .7 years and 1.3 ± .3 years since LCP-Tac conversion. Mean age was 52 ± 13 years; 70% were African American, 39% were female, 16% living donor and 12% donor after cardiac death (DCD). In the overall cohort, tac CV was 29.5% before conversion, which increased to 33.4% after LCP-Tac (p = .008). In those with Tac CV >30% (n = 86), conversion to LCP-Tac reduced variability (40.6% vs. 35.5%; p = .019) and for those with Tac CV >30% and nonadherence or med errors (n = 16), LCP-Tac conversion substantially reduced Tac CV (43.4% vs. 29.9%; p = .026). TTR significantly improved for those with Tac CV >30% with (52.4% vs. 82.8%; p = .027) or without nonadherence or med errors (64.8% vs. 73.2%; p = .005). CMV, BK, and overall infections were significantly higher prior to LCP-Tac conversion. In the overall cohort, 3% had rejection before conversion and 2% after (p = NS). At end of follow-up, graft and patient survival were 94% and 96%, respectively.

CONCLUSIONS

In those with high Tac CV, conversion to LCP-Tac is associated with a significant reduction in variability and improvement in TTR, particularly in those with nonadherence or medication errors.

摘要

背景

对于肾移植受者（KTR）中那些具有高他克莫司变异性的患者，将其转换为每日一次、延长释放的 LCP-他克莫司（Tac）的影响尚未得到充分研究。

方法

这是一项单中心、回顾性队列研究，纳入了在移植后 1-2 年内从 Tac 速释剂转换为 LCP-Tac 的成年 KTR。主要测量指标为 Tac 变异性，使用变异系数（CV）和治疗窗内时间（TTR），以及临床结局（排斥反应、感染、移植物丢失、死亡）。

结果

共纳入 193 名 KTR，随访时间为 3.2±0.7 年，LCP-Tac 转换后随访时间为 1.3±0.3 年。平均年龄为 52±13 岁；70%为非裔美国人，39%为女性，16%为活体供者，12%为心脏死亡后供者（DCD）。在整个队列中，转换前 Tac 的 CV 为 29.5%，转换为 LCP-Tac 后增加至 33.4%（p=0.008）。在 Tac CV>30%的患者中（n=86），转换为 LCP-Tac 可降低变异性（40.6% vs. 35.5%；p=0.019），而在 Tac CV>30%且存在用药不依从或用药错误的患者中（n=16），LCP-Tac 转换可显著降低 Tac CV（43.4% vs. 29.9%；p=0.026）。TTR 显著改善，在 Tac CV>30%且存在（52.4% vs. 82.8%；p=0.027）或不存在用药不依从或用药错误的患者中（64.8% vs. 73.2%；p=0.005）。CMV、BK 和总体感染在转换为 LCP-Tac 之前显著更高。在整个队列中，转换前有 3%的患者发生排斥反应，转换后有 2%的患者发生（p=NS）。在随访结束时，移植物和患者的存活率分别为 94%和 96%。