Ekberg H, Grinyó J, Nashan B, Vanrenterghem Y, Vincenti F, Voulgari A, Truman M, Nasmyth-Miller C, Rashford M
Lund University, Malmö, Sweden.
Am J Transplant. 2007 Mar;7(3):560-70. doi: 10.1111/j.1600-6143.2006.01645.x. Epub 2007 Jan 22.
Although the calcineurin inhibitors (CNI) cyclosporine (CsA) and tacrolimus are highly effective immunosuppressants, they are associated with serious side effects. There is great interest in immunosuppressive regimens that permit reduction or elimination of CNIs, while maintaining adequate immunosuppression and acceptable acute rejection rates. Patients (n = 536) receiving their first renal allograft were randomized to one of three immunosuppressant regimens: daclizumab, mycophenolate mofetil (MMF), corticosteroids (CS) and low-dose CsA (target trough levels of 50-100 ng/mL), weaned from month 4 and withdrawn by month 6; daclizumab, MMF, CS and low-dose CsA; or MMF, CS and standard-dose CsA. Mean GFR 12 months after transplantation (primary end point) was not statistically different in the CsA withdrawal and low-dose CsA groups (both 50.9 mL/min/1.73 m(2)) vs. the standard-dose CsA group (48.6 mL/min/1.73 m(2)). At 12 months, the incidence of biopsy-proven acute rejection was significantly higher in the CsA withdrawal group (38%) vs. the low- or standard-dose CsA groups (25.4% and 27.5%, respectively; p < 0.05). In summary, a regimen of continuous low-dose CsA with MMF, CS and daclizumab induction is a clinically safe and effective immunosuppressive regimen in renal transplant recipients.
尽管钙调神经磷酸酶抑制剂（CNI）环孢素（CsA）和他克莫司是高效的免疫抑制剂，但它们会引发严重的副作用。人们对免疫抑制方案有着浓厚兴趣，这些方案能够减少或停用CNI，同时维持足够的免疫抑制和可接受的急性排斥反应发生率。接受首次肾移植的患者（n = 536）被随机分为三种免疫抑制方案之一：达利珠单抗、霉酚酸酯（MMF）、皮质类固醇（CS）和低剂量CsA（目标谷浓度为50 - 100 ng/mL），从第4个月开始减量，第6个月停用；达利珠单抗、MMF、CS和低剂量CsA；或MMF、CS和标准剂量CsA。移植后12个月的平均肾小球滤过率（主要终点）在CsA撤药组和低剂量CsA组（均为50.9 mL/min/1.73 m²）与标准剂量CsA组（48.6 mL/min/1.73 m²）之间无统计学差异。在12个月时，活检证实的急性排斥反应发生率在CsA撤药组（38%）显著高于低剂量或标准剂量CsA组（分别为25.4%和27.5%；p < 0.05）。总之，对于肾移植受者，连续低剂量CsA联合MMF、CS及达利珠单抗诱导的方案是一种临床安全有效的免疫抑制方案。
