Nephrology Division, Hospital do Rim e Hipertensão, Rua Borges Lagoa 960, 11° andar, Vila Clementino, 04038-002 São Paulo, Brazil.
Int Urol Nephrol. 2011 Dec;43(4):1221-8. doi: 10.1007/s11255-011-0001-3. Epub 2011 Jul 15.
Calcineurin inhibitor (CNI) and steroid (ST) withdrawal are strategies under investigation to reduce long-term toxicities associated with current immunosuppressive regimens. We conducted a single center, prospective trial comparing the efficacy and safety of CNI or ST withdrawal in kidney transplant recipients receiving sirolimus-based immunosuppressive regimen.
Forty-seven recipients of first renal transplant with non-HLA-identical living donors received sirolimus (SRL), tacrolimus (TAC), and ST without induction therapy and were randomized to undergo ST (TAC/SRL group, n = 24) or TAC (SRL/ST group, n = 21) withdrawal 3 months after transplantation. Primary efficacy and safety endpoints were the incidence of biopsy-confirmed acute rejection (BCAR) and renal function at 12 months.
No differences were observed in the incidence of BCAR (4.2% vs. 9.5%), graft (95.8% vs. 95.6%), and patient (95.8% vs. 95.6%) survivals or in renal function (60 ± 11.5 vs. 63.4 ± 10.5 ml/min, P = 0.361). Higher mean cholesterol concentration was observed in the SRL/ST group (191.9 ± 63.3 vs. 241.6 ± 61.5 mg/dl, P = 0.019). Treatment discontinuation due to adverse events occurred in 12.5% of patients in TAC/SRL group and 21.7% in SRL/ST group.
Within this short period of observation, our study was unable to detect any significant difference in major transplant outcomes comparing CNI and ST elimination strategies.
钙调磷酸酶抑制剂（CNI）和类固醇（ST）的撤药是正在研究的策略，旨在减少与当前免疫抑制方案相关的长期毒性。我们进行了一项单中心、前瞻性试验，比较了在接受西罗莫司为基础的免疫抑制方案的肾移植受者中，CNI 或 ST 撤药的疗效和安全性。
47 名接受非 HLA 匹配活体供者的首次肾移植受者接受西罗莫司（SRL）、他克莫司（TAC）和 ST，无诱导治疗，并在移植后 3 个月随机接受 SRL 撤药（TAC/SRL 组，n=24）或 TAC 撤药（SRL/ST 组，n=21）。主要疗效和安全性终点是活检证实的急性排斥反应（BCAR）的发生率和 12 个月时的肾功能。
BCAR（4.2%对 9.5%）、移植物（95.8%对 95.6%）和患者（95.8%对 95.6%）存活率或肾功能（60±11.5 对 63.4±10.5 ml/min，P=0.361）无差异。SRL/ST 组的平均胆固醇浓度较高（191.9±63.3 对 241.6±61.5 mg/dl，P=0.019）。TAC/SRL 组有 12.5%的患者因不良反应而停药，SRL/ST 组有 21.7%的患者停药。
在这段观察期内，我们的研究未能检测到 CNI 和 ST 消除策略在主要移植结局方面的任何显著差异。
