Department of Nephrology and Clinical Immunology, Bretonneau Hospital, University Hospital, Tours, France.
Am J Transplant. 2012 Jul;12(7):1801-10. doi: 10.1111/j.1600-6143.2012.04036.x. Epub 2012 Apr 5.
Calcineurin inhibitors improve acute rejection rates and short-term graft survival in renal transplantation, but their continuous use may be deleterious. We evaluated the 5-year outcomes of sirolimus (SRL) versus cyclosporine (CsA) immunosuppressive treatment. This observational study was an extension of the SPIESSER study where deceased donor kidney transplant recipients were randomized before transplantation to a SRL- or CsA-based regimen and followed up 1 year. Data from 131 (63 SRL, 68 CsA) out of 133 patients living with a functional graft at 1 year were collected retrospectively at 5 years posttransplant. Seventy percent of CsA patients versus 54% of SRL patients were still on the allocated treatment at 5 years (p = 0.091), most discontinuations in each group being due to safety issues. In intent-to-treat, mean MDRD eGFR was higher with SRL: 54.2 versus 45.3 mL/min with CsA (p = 0.019); SRL advantage was greater in on-treatment analyses. There were no differences for patient survival (p = 0.873), graft survival (p = 0.121) and acute rejection (p = 0.284). Adverse events were more frequent with SRL (80% vs. 60%, p = 0.015). Results confirmed the high SRL discontinuation rate due to adverse events. Nevertheless, a benefit was evidenced on renal function in patients (more than 50%) still on treatment at 5 years.
钙调磷酸酶抑制剂可提高肾移植中的急性排斥反应率和短期移植物存活率，但持续使用可能有害。我们评估了西罗莫司（SRL）与环孢素（CsA）免疫抑制治疗的 5 年结果。这项观察性研究是 SPIESSER 研究的延伸，在该研究中，在移植前将已故供体肾移植受者随机分为 SRL 或 CsA 方案组，并在 1 年后进行随访。对 133 例在 1 年时存活且有功能移植物的患者中，有 131 例（63 例 SRL，68 例 CsA）的数据进行了回顾性收集，以评估移植后 5 年的结果。在第 5 年时，70%的 CsA 患者与 54%的 SRL 患者仍在接受分配的治疗（p=0.091），在每组中，大多数停药都是由于安全性问题。在意向治疗中，SRL 的平均 MDRD eGFR 更高：54.2 与 CsA 的 45.3 mL/min（p=0.019）；在治疗分析中，SRL 的优势更大。在患者生存率（p=0.873）、移植物生存率（p=0.121）和急性排斥反应（p=0.284）方面没有差异。SRL 的不良事件更常见（80% vs. 60%，p=0.015）。结果证实，由于不良事件，SRL 的停药率很高。然而，在 5 年时仍在接受治疗的患者（超过 50%）肾功能有获益。
