肾移植术后雷帕霉素临床短期对照试验

Clinical trial of sirolimus in patients with renal transplantation

目的:评价肾移植术后应用雷帕霉素(sirolimus,SRL)的疗效和药物的不良反应。方法:实验组:20例同种异体尸体供肾移植患者,免疫抑制方案为环孢素A(CsA)+SRL+强的松(Pred);对照组:15例同种异体尸体供肾移植患者,免疫抑制方案为CsA+霉酚酸酯(MMF)+Pred。对比二组在术后6个月内的疗效和药物的不良反应。结果:两组患者肾脏6个月内均带功能存活。实验室检查无统计学差异,但急性排斥发生率、并发症及药物的副作用明显不同。实验组(n=20):急性排斥1例(5%),移植肾功能延迟1例(5%),肺部感染3例(15%),血脂异常11例(55.0%,胆固醇升高3例,三酰甘油升高4例,二者皆升高4例),肝功能异常3例(15%);对照组(n=15):急性排斥2例(13.3%),肺部感染2例(13.3%),血脂异常5例(33.3%,胆固醇升高1例,三酰甘油升高2例,二者皆升高2例);腹泻6例(40%),白细胞减少1例。结论:肾移植术后应用CsA+SRL+Pred三联免疫抑制治疗方案,其急性排斥发生率低于CsA+MMF+Pred的方案,但血脂异常发生率较高。

Objective：To evaluate the efficacy and side effects of sirolimus （SRL） on patients with renal transplantation. Methodology： From April, 2003 to Oct, 2003, thirty-five petiennts with cadaveric kidney transplantation were enrolled this clinical trial. These patients were divided into two groups. They were experiment group （n = 20） ： CsA ＋ SRL ＋ Pred triple immunosuppressive regimen, and control group （ n = 15 ） ： CsA ＋ MMF ＋ Pred triple immunosuppressive regimen. The therapeutic efficacy and side effects were compared between two groups. Results：No patients died during the 6 months of this clinical trial. There were lower rate of acute rejection in patients with CsA ＋ SRL ＋ Pred triple regimen （5.0%） than that in control （ 13.3% ）. There was no statistical difference in the regular laboratory test, however, the side effects were significant difference between two groups. In experiment group, there were one case of delayed graft function （ DGF, 5.0% ）, 3 cases of lung infection （ 15.0% ）, 3 cases of abnormal liver function （ 15.0% ）, 11 cases of dyslipidemia （55 % ） , 3 cases of hypercholesteroiemia, 4 cases of hypertriglyceridemia and 4 cases of both them. In control group, there were 2 cases of lung infection （ 13.3% ）, 5 cases of dyslipidemia （ 33.3% ）, one case of hypercholesteroiemia, 2 cases of hypertriglyceridemia and 2 cases of both them. In addition to, 6 cases had diarrhea （40. 0% ）. Conclusion ：The morbidity of acute rejection of CsA ＋ SRL ＋ Pred triple immunosuppressive regimen may be lower than CsA ＋ MMF ＋ Pred regimen. The dyslipidemia may contribute to the major side effects of SRL.