Han Fei, Wu Jianyong, Huang Hongfeng, Zhang Xiaohui, He Qiang, Wang Yimin, Wang Suya, Wang Huiping, Chen Jianghua
Kidney Disease Center, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, PR China.
Exp Clin Transplant. 2011 Feb;9(1):42-9.
The long-term use of cyclosporine always contributes to chronic renal allograft dysfunction. Converting from cyclosporine to sirolimus and reducing cyclosporine dosage under high mycophenolate mofetil levels are 2 common therapies. Their efficacy and safety have not been compared in Chinese patients.
In this prospective, open label, randomized study, 51 kidney recipients with an estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m² were enrolled. Patients in the sirolimus group (n=22) initiated sirolimus 12 hours after cessation of cyclosporine. Patients in the cyclosporine group (n=29) significantly reduced cyclosporine dosage under high mycophenolate mofetil dosages. Both groups were followed-up for 4 years.
The baseline estimated glomerular filtration rate was 36.46 ± 6.22 mL/min/1.73 m² in sirolimus group and 36.07 ± 6.18 mL/min/1.73 m² in the cyclosporine group (P = NS). In cyclosporine group, the estimated glomerular filtration rate declined significantly at 12, 18, 24, 30, 36, 42, and 48 months after inclusion compared with baseline, and was lower than the sirolimus group at 30, 36, 42, and 48 months after inclusion (P < .05). As for the endpoints of graft loss and return to dialysis, the 4-year graft survival was 77.3% in the sirolimus group and 55.2% in the cyclosporine group (P = NS). As for the endpoint of serum creatinine doubling, 4-year survival was 77.3% in the sirolimus group and 41.4% in the cyclosporine group (P < .05). Three patients in sirolimus group (2 acute rejections, 1 pneumonia) and 2 patients in the cyclosporine group (owing to acute rejection) dropped out (P = NS).
Conversion from cyclosporine to sirolimus could improve long-term survival of renal grafts in Chinese patients.
长期使用环孢素总会导致慢性肾移植功能障碍。从环孢素转换为西罗莫司以及在高剂量霉酚酸酯水平下降低环孢素剂量是两种常见的治疗方法。在中国患者中，尚未对它们的疗效和安全性进行比较。
在这项前瞻性、开放标签、随机研究中，纳入了51名估计肾小球滤过率在30至60 mL/（min/1.73 m²）之间的肾移植受者。西罗莫司组（n = 22）的患者在停用环孢素12小时后开始使用西罗莫司。环孢素组（n = 29）的患者在高剂量霉酚酸酯的情况下显著降低环孢素剂量。两组均随访4年。
西罗莫司组的基线估计肾小球滤过率为36.46±6.22 mL/（min/1.73 m²），环孢素组为36.07±6.18 mL/（min/1.73 m²）（P =无显著性差异）。在环孢素组中，与基线相比，纳入后12、18、24、30、36、42和48个月时估计肾小球滤过率显著下降，且在纳入后30、36、42和48个月时低于西罗莫司组（P < 0.05）。至于移植物丢失和恢复透析的终点，西罗莫司组4年移植物存活率为77.3%，环孢素组为55.2%（P =无显著性差异）。至于血清肌酐翻倍的终点，西罗莫司组4年存活率为77.3%，环孢素组为41.4%（P < 0.05）。西罗莫司组有3名患者（2例急性排斥反应，1例肺炎）和环孢素组有2名患者（因急性排斥反应）退出研究（P =无显著性差异）。
在中国患者中，从环孢素转换为西罗莫司可提高肾移植的长期存活率。
