Tsuchiya T, Ishida K, Ito S, Deguchi T
Department of Urology, Gifu University School of Medicine, Gifu, Japan.
Transplant Proc. 2012 Jan;44(1):118-20. doi: 10.1016/j.transproceed.2011.11.027.
Tacrolimus is an established immunosuppressant for the prevention and treatment of allograft rejection in organ transplantation. However, tacrolimus therapy also has several adverse effects. The main aim of this study was to evaluate the effect of conversion from twice-daily tacrolimus (tacrolimus-BID) to once-daily tacrolimus (tacrolimus-OD) on glucose intolerance in stable kidney transplant patients.
The study comprised 43 kidney transplant recipients with stable renal function. The same 1 mg:1 mg dose conversion was used for all patients. Follow-up, which included clinical evaluation and laboratory testing, was performed at 30, 60, and 120 days after conversion. The parameters for which the baseline and end-point values were determined included homeostasis model assessment of beta-cell function (HOMA-B) scores, hemoglobin A(1c) (HbA(1c)) levels, serum insulin levels, and fasting glucose levels.
The tacrolimus trough levels did not differ significantly at 120 days after conversion. There was a significant increase in serum insulin level at 120 days after conversion (baseline, 5.6 ± 2.7 μU/mL; end point, 6.6 ± 3.4 μU/mL; P < .009). The HOMA-B score slightly increased (baseline, 58.7 ± 33.1; end point, 65.6 ± 32.8; P = .091) at 120 days after conversion, indicating beta-cell function. Serum creatinine concentration, blood glucose level, and HbA(1c) level did not change significantly during follow-up examinations. Episodes of acute rejection or graft loss did not occur.
The results of this study suggests that conversion from tacrolimus-BID to tacrolimus-OD may benefit kidney transplant patients with glucose intolerance because of improved insulin secretion. Further studies involving a larger sample population and longer follow-up time are required to verify the results of this study.
他克莫司是一种已被认可的免疫抑制剂，用于预防和治疗器官移植中的同种异体移植排斥反应。然而，他克莫司治疗也有若干不良反应。本研究的主要目的是评估在稳定的肾移植患者中，将每日两次他克莫司（他克莫司 bid）转换为每日一次他克莫司（他克莫司 od）对葡萄糖不耐受的影响。
该研究纳入了 43 名肾功能稳定的肾移植受者。所有患者均采用相同的 1 mg:1 mg 剂量转换。在转换后 30、60 和 120 天进行随访，包括临床评估和实验室检测。测定基线和终点值的参数包括β细胞功能的稳态模型评估（HOMA-B）评分、糖化血红蛋白 A1c（HbA1c）水平、血清胰岛素水平和空腹血糖水平。
转换后 120 天，他克莫司谷浓度无显著差异。转换后 120 天血清胰岛素水平显著升高（基线值，5.6±2.7 μU/mL；终点值，6.6±3.4 μU/mL；P <.009）。转换后 120 天，HOMA-B 评分略有升高（基线值，58.7±33.1；终点值，65.6±32.8；P =.091），表明β细胞功能。随访期间血清肌酐浓度、血糖水平和 HbA1c 水平无显著变化。未发生急性排斥反应或移植物丢失事件。
本研究结果表明，从他克莫司 bid 转换为他克莫司 od 可能使葡萄糖不耐受的肾移植患者受益，因为胰岛素分泌得到改善。需要进一步开展涉及更大样本量人群和更长随访时间的研究来验证本研究结果。
