Shenoy Surendra, Hardinger Karen L, Crippin Jeffrey, Desai Niraj, Korenblat Kevin, Lisker-Melman Mauricio, Lowell Jeffrey A, Chapman William
The Department of Surgery, Washington University, St Louis, MO 63110, USA.
Transplantation. 2007 May 27;83(10):1389-92. doi: 10.1097/01.tp.0000261630.63550.41.
This pilot trial was designed to assess the safety and efficacy of SRL in liver transplant recipients with renal dysfunction. Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm). Improvement in 24-hour CrCl was seen in the SRL arm at 3 months (75 mL/min SRL vs. 56 mL/min control, P=0.012), whereas at 12 months there was a trend toward improvement in the SRL arm (72 mL/min SRL vs. 58 mL/min control, P=0.09). Two patients, one in each arm, developed steroid-sensitive rejection. Side effects of SRL were limited and included hyperlipidemia requiring treatment (15%), pruritus (5%), and mouth sores (25%). In this trial, SRL-based immunosuppression was a safe alternative to CNI. Although early improvements were observed, withdrawing CNI and replacing it with SRL did not result in a statistically significant improvement in renal function at 12 months of follow-up.
这项初步试验旨在评估西罗莫司（SRL）在肾功能不全的肝移植受者中的安全性和疗效。40例肾功能不全患者（24小时肌酐清除率[CrCl]为40 - 80 mL/分钟）被随机分为停用钙调神经磷酸酶抑制剂（CNI）并接受西罗莫司（SRL）组或继续使用CNI组（对照组）。在3个月时，SRL组的24小时CrCl有所改善（SRL组为75 mL/分钟，对照组为56 mL/分钟，P = 0.012），而在12个月时，SRL组有改善趋势（SRL组为72 mL/分钟，对照组为58 mL/分钟，P = 0.09）。每组各有1例患者发生类固醇敏感型排斥反应。SRL的副作用有限，包括需要治疗的高脂血症（15%）、瘙痒（5%）和口腔溃疡（25%）。在本试验中，基于SRL的免疫抑制是CNI的一种安全替代方案。尽管观察到早期有改善，但在随访12个月时，停用CNI并用SRL替代并未导致肾功能有统计学意义的改善。
