Nafar Mohsen, Alipour Behrang, Ahmadpoor Pedram, Pour-Reza-Gholi Fatemeh, Samadian Fariba, Samavat Shiva, Farhangi Soudabeh
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Kidney Dis. 2012 Jul;6(4):300-6.
Sirolimus is the one of new immunosuppressants that may be a substitute to traditional drugs such as cyclosporine. We present our investigation on sirolimus-based immunosuppression in kidney transplant recipients as compared with cyclosporine-based immunosuppression.
We enrolled 100 patients in an open-labeled randomized clinical trial at Shahid Labbafinejad Medical Center. The patients were assigned to one of the immunosuppressive groups to receive either sirolimus or cyclosporine in combination with mycophenolate mofetil and steroids. All kidney transplant recipients were followed up by for serum creatinine and glomerular filtration rate for 4 years.
There was no significant differences between the two groups regarding serum creatinine level and GFR until for years posttransplant; however, serum creatinine levels were significantly lower and the GFRs were higher in the sirolimus group after 3 and 4 years. The mean serum creatinine was 1.24 ± 0.28 mg/dL in the sirolimus group and 1.57 ± 0.33 mg/dL in the cyclosporine group at 4 years posttransplant (P = .02). Also, GFR was 79.8 ± 22.3 mL/min/1.73 m2 in the sirolimus group and 70.3 ± 23.6 mL/min/1.73 m2 in the cyclosporine group B (P = .04). Acute rejection was 1.7-fold higher in the cyclosporine group than in the sirolimus group.
Our study demonstrated that sirolimus in the immunosuppressive regimen of kidney transplant recipients had better outcomes regarding graft and patient survival. The effectiveness of sirolimus for kidney allograft recipients should be further assessed to be implemented from the first day after transplantation.
西罗莫司是新型免疫抑制剂之一，可能替代环孢素等传统药物。我们呈现了对肾移植受者基于西罗莫司的免疫抑制与基于环孢素的免疫抑制的研究。
我们在沙希德·拉巴菲内贾德医疗中心开展了一项开放标签的随机临床试验，纳入了100名患者。患者被分配至免疫抑制组之一，接受西罗莫司或环孢素联合霉酚酸酯和类固醇治疗。所有肾移植受者随访4年，监测血清肌酐和肾小球滤过率。
移植后数年，两组在血清肌酐水平和肾小球滤过率方面无显著差异；然而，3年和4年后，西罗莫司组的血清肌酐水平显著更低，肾小球滤过率更高。移植后4年，西罗莫司组的平均血清肌酐为1.24±0.28mg/dL，环孢素组为1.57±0.33mg/dL（P = 0.02）。此外，西罗莫司组的肾小球滤过率为79.8±22.3mL/min/1.73m²，环孢素组为70.3±23.6mL/min/1.73m²（P = 0.04）。环孢素组的急性排斥反应比西罗莫司组高1.7倍。
我们的研究表明，在肾移植受者的免疫抑制方案中，西罗莫司在移植物和患者存活方面有更好的结果。西罗莫司对肾移植受者的有效性应进一步评估，以便在移植后第一天就开始应用。
