Turunc Volkan, Ari Elif, Guven Bahtisen, Tabendeh Babek, Yildiz Aladdin
Department of General Surgery, Bahcesehir University, Istanbul, Turkey.
Department of Nephrology, Bahcesehir University, Istanbul, Turkey.
Transplant Proc. 2019 Sep;51(7):2308-2311. doi: 10.1016/j.transproceed.2019.01.149. Epub 2019 Aug 7.
This study aimed to determine whether de novo, prolonged-release tacrolimus- (PR-tacro) based immunosuppressive regimen affected graft and patient survival when compared to an immediate-release, twice-daily, tacrolimus- (IR-tacro) based regimen in kidney transplant recipients. We also aimed to determine the difference between the frequency of side effects, including diabetes control, in study groups.
A total of 115 standard risk kidney transplant recipients were enrolled in this single center, retrospective study. Fifty-two patients received PR-tacro and 63 patients received IR-tacro as a calcineurin inhibitor. The primary outcome measures included incidence of graft loss and delayed graft function (DGF), biopsy-proven acute rejection , graft and patient survival, and creatinine clearance. Secondary outcome measures included the incidence of non-adherence, drug-induced tremor; post-transplant diabetes mellitus diagnosis rate; and control of diabetes in pre-transplant diabetic patients.
Baseline characteristics and mean tacrolimus trough levels were comparable between groups. Incidence of graft loss, DGF, and graft and patient survival were similar between groups (P > .05). Mean creatinine clearance level was also similar (P > .05). Mean serum levels of fasting glucose (P < .05) and A1C (P < .05) were lower in PR-tacro group when compared to IR-tacro group. Post-transplant diabetes mellitus diagnosis rate was also lower in PR-tacro group when compared to IR-tacro group (P = .040).
This study suggests that there is no statistically significant difference between PR-tacro and IR-tacro in terms of patient and graft survival, DGF, and biopsy-proven acute rejection rates in kidney transplant recipients. Post-transplant diabetes mellitus frequency is lower in non-diabetic patients, and glucose metabolism control is better in diabetic patients.
本研究旨在确定与基于速释、每日两次他克莫司（IR-他克莫司）的免疫抑制方案相比，基于新型长效他克莫司（PR-他克莫司）的免疫抑制方案对肾移植受者的移植物和患者生存率是否有影响。我们还旨在确定研究组之间副作用发生频率的差异，包括糖尿病控制情况。
共有115例标准风险的肾移植受者纳入了这项单中心回顾性研究。52例患者接受PR-他克莫司，63例患者接受IR-他克莫司作为钙调神经磷酸酶抑制剂。主要观察指标包括移植物丢失和延迟性移植物功能恢复（DGF）的发生率、活检证实的急性排斥反应、移植物和患者生存率以及肌酐清除率。次要观察指标包括不依从的发生率、药物性震颤、移植后糖尿病的诊断率以及移植前糖尿病患者的糖尿病控制情况。
两组之间的基线特征和他克莫司平均谷浓度具有可比性。两组之间移植物丢失、DGF以及移植物和患者生存率相似（P>.05）。平均肌酐清除率水平也相似（P>.05）。与IR-他克莫司组相比，PR-他克莫司组的空腹血糖（P<.05）和糖化血红蛋白（A1C）（P<.05）平均血清水平较低。与IR-他克莫司组相比，PR-他克莫司组的移植后糖尿病诊断率也较低（P=.040）。
本研究表明，在肾移植受者的患者和移植物生存率、DGF以及活检证实的急性排斥反应率方面，PR-他克莫司和IR-他克莫司之间没有统计学上的显著差异。非糖尿病患者移植后糖尿病的发生率较低，糖尿病患者的糖代谢控制较好。
