Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil.
Am J Transplant. 2013 Dec;13(12):3155-63. doi: 10.1111/ajt.12481. Epub 2013 Oct 30.
Planned conversion from tacrolimus to sirolimus was evaluated in de novo kidney transplant recipients. In this multicenter, randomized, open-label study, 297 patients were initially treated with tacrolimus, mycophenolate sodium and prednisone. Of the 283 patients reaching 3 months, 97 were converted to sirolimus (SRL), 107 were maintained on tacrolimus (TAC) and 79 were patients receiving TAC without criteria to undergo intervention at month 3 (TACex). The primary objective was to show superior estimated glomerular filtration rate (eGFR) in the SRL group at month 24. Of the 258 patients who completed 24 months, 91 (94%) were in the SRL group, 101 (94%) in the TAC group and 66 (84%) in the TACex group. In the intention-to-treat population there were no differences in eGFR (66.2 ± 25.3 vs. 70.7 ± 25.1, p = 0.817) or in the severity of chronic sclerosing lesions scores in 24-month protocol biopsies. Higher mean urinary protein-to-creatinine ratio (0.36 ± 0.69 vs. 0.15 ± 0.53, p = 0.03) and higher incidence of treated acute rejection between months 3-24 (13.4% vs. 4.7%, p = 0.047) were observed in SRL compared to TAC group. In this population planned conversion from TAC to SRL 3 months after kidney transplantation was not associated with improved renal function at 24 months.
本研究旨在评估在肾移植初治患者中，从他克莫司转换为西罗莫司的方案。该多中心、随机、开放性研究共纳入 297 例患者，最初接受他克莫司、吗替麦考酚酯钠和泼尼松治疗。在 283 例达到 3 个月的患者中，97 例转换为西罗莫司（SRL），107 例继续接受他克莫司（TAC）治疗，79 例患者在 3 个月时未达到干预标准而继续接受 TAC 治疗（TACex）。主要终点为在第 24 个月时，SRL 组估算肾小球滤过率（eGFR）有更好的改善。在完成 24 个月随访的 258 例患者中，91 例（94%）进入 SRL 组，101 例（94%）进入 TAC 组，66 例（84%）进入 TACex 组。在意向性治疗人群中，两组的 eGFR（66.2 ± 25.3 比 70.7 ± 25.1，p = 0.817）或 24 个月方案活检中慢性硬化性病变严重程度评分无差异。与 TAC 组相比，SRL 组的平均尿蛋白/肌酐比值更高（0.36 ± 0.69 比 0.15 ± 0.53，p = 0.03），3-24 个月时治疗后急性排斥的发生率更高（13.4%比 4.7%，p = 0.047）。在该人群中，肾移植后 3 个月计划从 TAC 转换为 SRL 与 24 个月时肾功能的改善无关。
