Ahsan N, Johnson C, Gonwa T, Halloran P, Stegall M, Hardy M, Metzger R, Shield C, Rocher L, Scandling J, Sorensen J, Mulloy L, Light J, Corwin C, Danovitch G, Wachs M, VanVeldhuisen P, Salm K, Tolzman D, Fitzsimmons W E
Milton S. Hershey Medical Center, Hershey, PA 17104-1696, USA.
Transplantation. 2001 Jul 27;72(2):245-50. doi: 10.1097/00007890-200107270-00014.
A previous report described the 1-year results of a prospective, randomized trial designed to investigate the optimal combination of immunosuppressants in kidney transplantation. Recipients of first cadaveric kidney allografts were treated with tacrolimus+mycophenolate mofetil (MMF), cyclosporine oral solution (modified) (CsA)+MMF, or tacrolimus+azathioprine (AZA). Results at 1 year revealed that optimal efficacy and safety were achieved with a regimen containing tacrolimus+MMF. The present report describes results at 2 years.
Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus+MMF, CsA+MMF, or tacrolimus+AZA. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function. Patients were followed up for 2 years.
The results at 2 years corroborate and extend the findings of the previous report. Patients randomized to either treatment arm containing tacrolimus experienced improved kidney function. New-onset insulin dependence remained in four, three, and four patients in the tacrolimus+MMF, CsA+MMF, and tacrolimus+AZA treatment arms, respectively. Furthermore, patients with delayed graft function/acute tubular necrosis who were treated with tacrolimus+MMF experienced a 23% increase in allograft survival compared with patients receiving CsA+MMF (P=0.06). Patients randomized to tacrolimus+MMF received significantly lower doses of MMF compared with those administered CsA+MMF.
All three immunosuppressive regi-mens provided excellent safety and efficacy. How-ever, the best results overall were achieved with tacrolimus+MMF. The combination may provide particular benefit to kidney allograft recipients who develop delayed graft function/acute tubular necrosis. Renal function at 2 years was better in the tacrolimus treatment groups compared with the CsA group.
之前的一份报告描述了一项前瞻性随机试验的1年结果，该试验旨在研究肾移植中免疫抑制剂的最佳组合。首次尸体肾移植受者接受他克莫司+霉酚酸酯（MMF）、环孢素口服溶液（改良型）（CsA）+MMF或他克莫司+硫唑嘌呤（AZA）治疗。1年时的结果显示，含他克莫司+MMF的方案可实现最佳疗效和安全性。本报告描述了2年时的结果。
223例首次尸体肾移植受者被随机分配接受他克莫司+MMF、CsA+MMF或他克莫司+AZA治疗。所有方案均包含皮质类固醇，仅在发生移植肾功能延迟的患者中使用抗体诱导治疗。对患者进行了2年的随访。
2年时的结果证实并扩展了之前报告的结果。随机分配到含他克莫司治疗组的患者肾功能得到改善。他克莫司+MMF、CsA+MMF和他克莫司+AZA治疗组分别有4例、3例和4例患者出现新发胰岛素依赖。此外，与接受CsA+MMF治疗的患者相比，接受他克莫司+MMF治疗的移植肾功能延迟/急性肾小管坏死患者的移植肾存活率提高了23%（P=0.06）。与接受CsA+MMF治疗的患者相比，随机分配到他克莫司+MMF治疗组的患者接受的MMF剂量显著更低。
所有三种免疫抑制方案均具有出色的安全性和疗效。然而，总体上最佳结果是使用他克莫司+MMF取得的。该组合可能对发生移植肾功能延迟/急性肾小管坏死的肾移植受者特别有益。与CsA组相比，他克莫司治疗组2年时的肾功能更好。
