Kim S J, Lee K W, Lee D S, Lee H H, Lee S K, Kim B, Huh W S, Oh H Y, Joh J W
Department of Surgery, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.
Transplant Proc. 2004 Sep;36(7):2098-100. doi: 10.1016/j.transproceed.2004.08.070.
The introduction of new immunosuppressants has prompted trials of steroid withdrawal. However, several groups have reported a higher incidence of rejection. We conducted a randomized two-arm, parallel-group, open-label, prospective study to compare steroid withdrawal (at 6 months posttransplant) from the regimens of tacrolimus + mycophenolate mofetil (MMF) (FK group) versus cyclosporine + MMF (CSA group). The entry criteria were recipients of first living donor transplants with no diabetes mellitus (DM), congestive heart failure, chronic liver disease, or acute rejection within 6 months posttransplant. The primary endpoint was a biopsy-proven acute rejection episode or treatment failure within 1 year posttransplant. While 87 recipients were assigned to FK (n = 43) and CSA groups (n = 44) before transplantation, 76 recipients (FK 39, CSA 37) could be tapered off steroids at 6 months posttransplant, since 11 were excluded due to acute rejection within 6 months posttransplant (FK two, CSA three) or protocol violations (FK two, CSA four). After steroid withdrawal, the incidence of acute rejection episodes was 0% in the FK group and 13.5% in the CSA group (P < .05). Other results at 12 months posttransplantation were comparable: the incidences of DM 7.8% versus 0% (FK group vs CSA group), hypercholesterolemia 41.0% versus 59.5%, hypertensives 48.7% versus 59.6% as well as the levels of plasma creatinine 1.21 +/- 0.24 versus 1.31 +/- 0.50 mg/dL (P > .05 in every variable). These data suggest that steroid withdrawal is successful in first living donor renal transplant recipients. Tacrolimus may be significantly more effective than cyclosporine to prevent acute rejection after steroid withdrawal.
新型免疫抑制剂的引入促使了撤减类固醇的试验。然而，多个研究小组报告称排斥反应的发生率更高。我们进行了一项随机双臂、平行组、开放标签的前瞻性研究，以比较在他克莫司+霉酚酸酯（MMF）方案（FK组）与环孢素+MMF方案（CSA组）中撤减类固醇（移植后6个月）的情况。入选标准为首次接受活体供体移植的受者，无糖尿病（DM）、充血性心力衰竭、慢性肝病，且在移植后6个月内无急性排斥反应。主要终点是移植后1年内经活检证实的急性排斥反应发作或治疗失败。虽然在移植前87名受者被分配到FK组（n = 43）和CSA组（n = 44），但76名受者（FK组39名，CSA组37名）在移植后6个月能够逐渐停用类固醇，因为有11名受者因移植后6个月内发生急性排斥反应（FK组2名，CSA组3名）或违反方案（FK组2名，CSA组4名）而被排除。撤减类固醇后，FK组急性排斥反应发作的发生率为0%，CSA组为13.5%（P <.05）。移植后12个月的其他结果相当：DM的发生率分别为7.8%和0%（FK组 vs CSA组），高胆固醇血症分别为41.0%和59.5%，高血压分别为48.7%和59.6%，以及血浆肌酐水平分别为1.21±0.24和1.31±0.50mg/dL（各变量P >.05）。这些数据表明，撤减类固醇在首次接受活体供体肾移植的受者中是成功的。在撤减类固醇后预防急性排斥反应方面，他克莫司可能比环孢素显著更有效。
