Department of Nephrology, Clinical Immunology, University Hospital, François Rabelais University, Tours, France.
Am J Transplant. 2011 Aug;11(8):1665-75. doi: 10.1111/j.1600-6143.2011.03637.x.
Calcineurin inhibitor (CNI) withdrawal has been used as a strategy to improve renal allograft function. We previously reported that conversion from cyclosporine A (CsA) to sirolimus (SRL) 3 months after transplantation significantly improved renal function at 1 year. In the Postconcept trial, 77 patients in the SRL group and 85 in the CsA group were followed for 48 months. Renal function (Cockcroft and Gault) was significantly better at month 48 (M48) in the SRL group both in the intent-to-treat population (ITT): 62.6 mL/min/1.73 m(2) versus 57.1 mL/min/1.73 m(2) (p = 0.013) and in the on-treatment population (OT): 67.5 mL/min/1.73 m(2) versus 57.4 mL/min/1.73 m(2) (p = 0.002). Two biopsy proven acute rejection episodes occurred after M12 in each group. Graft and patient survival were comparable (graft survival: 97.4 vs. 100%; patient survival: 97.4 vs. 97.6%, respectively). The incidence of new-onset diabetes was numerically increased in the SRL group (7 vs. 2). In OT, three cancers occurred in the SRL group versus nine in the CsA group and mean proteinuria was increased in the SRL group (0.42 ± 0.44 vs. 0.26 ± 0.37; p = 0.018). In summary, the renal benefits associated with conversion of CsA to SRL, at 3 months posttransplantation, in combination with MMF were maintained for 4 years posttransplantation.
钙调磷酸酶抑制剂（CNI）的撤药被用作改善肾移植功能的策略。我们之前报道过，在移植后 3 个月将环孢素 A（CsA）转换为西罗莫司（SRL）可显著改善 1 年后的肾功能。在 Postconcept 试验中，SRL 组的 77 例患者和 CsA 组的 85 例患者随访 48 个月。SRL 组的肾功能（Cockcroft 和 Gault）在第 48 个月（M48）时显著更好，在意向治疗人群（ITT）中：62.6 mL/min/1.73 m(2)比 57.1 mL/min/1.73 m(2)（p = 0.013）和在治疗人群（OT）中：67.5 mL/min/1.73 m(2)比 57.4 mL/min/1.73 m(2)（p = 0.002）。两组在 M12 后均各发生 2 例活检证实的急性排斥反应。移植物和患者的存活率相当（移植物存活率：97.4%对 100%；患者存活率：97.4%对 97.6%）。SRL 组新发生的糖尿病发生率略有增加（7 例对 2 例）。在 OT 中，SRL 组发生了 3 例癌症，而 CsA 组发生了 9 例，SRL 组的平均蛋白尿增加（0.42 ± 0.44 对 0.26 ± 0.37；p = 0.018）。总之，在移植后 3 个月将 CsA 转换为 SRL 联合 MMF 与肾移植后 4 年的肾功能获益相关。
