Nanni Alexis N, Harris Matthew, Watson Mara, Yang Zidanyue, Lee Hui-Jie, DeVore Adam D, Henderson James B
Department of Pharmacy, Duke University Hospital, Durham, North Carolina, USA.
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
Clin Transplant. 2022 Mar;36(3):e14542. doi: 10.1111/ctr.14542. Epub 2021 Nov 28.
Currently, clinicians often delay initiation of tacrolimus after orthotopic heart transplantation (OHT) to help mitigate nephrotoxicity. This study aimed to determine if there is an association between the time-to-therapeutic range (TTT) of tacrolimus, early renal dysfunction, and acute cellular rejection (ACR) after OHT.
This was a retrospective, single center study with adult patients who underwent OHT from July 2013 to April 2020. Logistic regression analysis was utilized to examine the association of TTT with new renal dysfunction after tacrolimus initiation post-OHT.
In a study of 317 patients, the unadjusted analysis showed patients who developed new renal dysfunction after tacrolimus initiation had a numerically shorter TTT (9.5 vs. 11.0 days, P = .065), and were more likely to have supratherapeutic tacrolimus levels (56% vs. 39.2%, P = .010). When adjusted for established risk factors for renal dysfunction, TTT was significantly associated with new renal dysfunction (OR .95; 95% CI [.90, .99], P = .03). There was no association between TTT and the incidence of ACR (11.1 vs. 10.8 days, P = .64).
When adjusting for known risk factors, a shorter TTT was associated with new renal dysfunction. Supratherapeutic tacrolimus levels were also associated with new renal dysfunction. There was no association between TTT and ACR in the setting of high use basiliximab induction.
目前,临床医生常在原位心脏移植(OHT)后延迟启动他克莫司治疗,以减轻肾毒性。本研究旨在确定OHT后他克莫司达到治疗范围的时间(TTT)与早期肾功能障碍及急性细胞排斥反应(ACR)之间是否存在关联。
这是一项回顾性单中心研究,纳入了2013年7月至2020年4月接受OHT的成年患者。采用逻辑回归分析来检验TTT与OHT后启动他克莫司治疗后新发肾功能障碍之间的关联。
在一项针对317例患者的研究中,未经调整的分析显示,他克莫司启动治疗后出现新发肾功能障碍的患者TTT在数值上较短(9.5天对11.0天,P = 0.065),且更有可能出现他克莫司水平高于治疗范围的情况(56%对39.2%,P = 0.010)。在对已确定的肾功能障碍危险因素进行调整后,TTT与新发肾功能障碍显著相关(OR 0.95;95% CI [0.90, 0.99],P = 0.03)。TTT与ACR的发生率之间无关联(11.1天对10.8天,P = 0.64)。
在对已知危险因素进行调整后,较短的TTT与新发肾功能障碍相关。他克莫司水平高于治疗范围也与新发肾功能障碍相关。在高剂量使用巴利昔单抗诱导的情况下,TTT与ACR之间无关联。