Andrés A, Delgado-Arranz M, Morales E, Dipalma T, Polanco N, Gutierrez-Solis E, Morales J M, Praga M, Gutierrez E, Gonzalez E
Nephrology Department, Hospital 12 de Octubre, Madrid, Spain.
Transplant Proc. 2010 Oct;42(8):3034-7. doi: 10.1016/j.transproceed.2010.07.044.
Available data for extended-release tacrolimus (Tac) except in clinical trials are limited.
To describe our initial experience with once-daily Tac in combination with corticosteroids and mycophenolate mofetil therapy in patients undergoing de novo renal transplantation.
In this retrospective, observational, single-center study, data were obtained for 49 adult recipients treated with extended-release Tac and 30 patients treated with standard-release Tac (control group). Mean (SD) follow-up in the 2 groups was 3.5 (2.5) months and 4.0 (2.6) months, respectively. The primary characteristics were comparable between the groups.
The acute rejection rate in the extended-release group was 10%, and 13% in the standard-release group. Patient and graft survival rates were 98% and 96% vs 100% and 90%, respectively. Renal function in the 2 groups was comparable: serum creatinine concentration 1.3 (0.2) mg/dL vs 1.45 (0.4) mg/dL. At day 14 posttransplantation, Tac doses were 0.17 mg/kg/d vs 0.14 mg/kg/d, and blood concentrations were 9.0 ng/mL vs 14.0 ng/mL. In recipients older than 60 years, lower dosages of Tac resulted in blood concentrations similar to those in younger patients, with less variation in dosage.
Short-term experience with extended-release Tac therapy in de novo renal recipients confirms its efficacy and safety. Adjusting blood concentrations in the immediate posttransplantation period is less difficult with extended-release Tac compared with the twice-daily formulation.
除临床试验外，关于缓释他克莫司（Tac）的可用数据有限。
描述我们在初次肾移植患者中每日一次使用Tac联合皮质类固醇和霉酚酸酯治疗的初步经验。
在这项回顾性、观察性、单中心研究中，获取了49例接受缓释Tac治疗的成年受者和30例接受标准释放Tac治疗的患者（对照组）的数据。两组的平均（标准差）随访时间分别为3.5（2.5）个月和4.0（2.6）个月。两组的主要特征具有可比性。
缓释组的急性排斥率为10%，标准释放组为13%。患者和移植物存活率分别为98%和96%，而对照组为100%和90%。两组的肾功能相当：血清肌酐浓度分别为1.3（0.2）mg/dL和1.45（0.4）mg/dL。移植后第14天，Tac剂量分别为0.17 mg/kg/d和0.14 mg/kg/d，血药浓度分别为9.0 ng/mL和14.0 ng/mL。在60岁以上的受者中，较低剂量的Tac导致的血药浓度与年轻患者相似，且剂量变化较小。
初次肾移植受者使用缓释Tac治疗的短期经验证实了其有效性和安全性。与每日两次给药的剂型相比，缓释Tac在移植后即刻调整血药浓度的难度较小。
