Huang Hongfeng, Xie Wenqing, Wu Jianyong, Xu Ying, Yu Xianping, Ren Pingping, Chen Jianghua
Kidney Disease Center, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China.
Kidney Disease Center, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China. Email:
Zhonghua Yi Xue Za Zhi. 2014 Nov 18;94(42):3293-7.
OBJECTIVE: To explore the efficacy and safety of designed early conversion from calcineurin inhibitor (CNI) to sirolimus (SRL) as major immunosuppressive therapy in renal transplant recipients with stable renal function. METHODS: A prospective, open-label and non-randomized control study was performed for 112 renal transplant recipients (3-6 months post-operation) with stable renal function between June 2008 and June 2011. The patients in SRL group (n = 57) switched to sirolimus while those in CNI group (n = 55) continued CNI. The dosing of mycophenolate mofetil and steroids had no change. They were followed up for at least 24 months to evaluate the acute rejection, patient and graft survival, renal function, estimated glomerular filtration rate (eGFR), blood lipids, blood glucose, liver function and urinary protein at 1, 6, 12 and 24 months after inclusion. Adverse events were also recorded. RESULTS: The serum creatinine of SRL group decreased significantly after conversion ( (89.2 ± 24.7), (87.6 ± 23.8), (86.1 ± 20.4), (86.7 ± 19.7) vs (117.0 ± 16.3) µmol/L, all P < 0.05). CNI group showed no improvement of renal function.SRL group had a significantly higher eGFR than CNI group (P < 0.05). Among 3 cases of acute rejection, there were 2 in SRL group and 1 in CNI group (P > 0.05). Blood lipids in SRL group increased significantly at 1 month after conversion (P < 0.05) and reverted back to average level after intervention (P > 0.05).SRL group had a drop of hemoglobin level within the normal range. Two patients in SRL group developed hypokalemia and another 2 patients had oral ulcer. They all improved after treatment. During follow-ups, 1 case of mild proteinuria was found in SIR group. Three patients were diagnosed with diabetes (1 in SRL group vs 2 in CNI group). CONCLUSIONS: Early conversion from CNI to SRL as major immunosuppressive therapy in renal transplant recipients with stable renal function further improves renal function. There is no higher rate of acute rejection during follow-up.Elevated blood lipids after conversion may be easily controlled. No other adverse events are found.
目的：探讨在肾功能稳定的肾移植受者中，将钙调神经磷酸酶抑制剂（CNI）早期转换为西罗莫司（SRL）作为主要免疫抑制治疗的疗效和安全性。 方法：对2008年6月至2011年6月期间112例肾功能稳定的肾移植受者（术后3 - 6个月）进行了一项前瞻性、开放标签和非随机对照研究。SRL组（n = 57）患者转换为西罗莫司，而CNI组（n = 55）患者继续使用CNI。霉酚酸酯和类固醇的剂量不变。对他们进行至少24个月的随访，以评估纳入后1、6、12和24个月时的急性排斥反应、患者和移植物存活率、肾功能、估计肾小球滤过率（eGFR）、血脂、血糖、肝功能和尿蛋白。还记录了不良事件。 结果：SRL组转换后血清肌酐显著下降（（89.2±24.7）、（87.6±23.8）、（86.1±20.4）、（86.7±19.7）对（117.0±16.3）µmol/L，所有P<0.05）。CNI组肾功能无改善。SRL组的eGFR显著高于CNI组（P<0.05）。在3例急性排斥反应中，SRL组有2例，CNI组有1例（P>0.05）。SRL组转换后1个月血脂显著升高（P<0.05），干预后恢复至平均水平（P>0.05）。SRL组血红蛋白水平在正常范围内下降。SRL组有2例患者发生低钾血症，另外2例患者有口腔溃疡。治疗后均有改善。随访期间，SIR组发现1例轻度蛋白尿。3例患者被诊断为糖尿病（SRL组1例，CNI组2例）。 结论：在肾功能稳定的肾移植受者中，将CNI早期转换为SRL作为主要免疫抑制治疗可进一步改善肾功能。随访期间急性排斥反应发生率没有更高。转换后血脂升高可能易于控制。未发现其他不良事件。
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