ter Meulen Cornelis G, van Riemsdijk Iza, Hené Ronald J, Christiaans Maarten H L, Borm George F, van Gelder Teun, Hilbrands Luuk B, Weimar Willem, Hoitsma Andries J
Department of Internal Medicine, Division of Nephrology, University Medical Center Nijmegen, Nijmegen, the Netherlands.
Am J Transplant. 2004 May;4(5):803-10. doi: 10.1111/j.1600-6143.2004.00419.x.
Steroids have been included in most immunosuppressive regimens after renal transplantation, but are feared for their side-effects. We conducted a prospective multicenter study to investigate whether it is feasible to withdraw steroids early after transplantation with the use of anti-IL-2Ralpha induction, tacrolimus and mycophenolate mofetil (MMF). A total of 364 patients were randomized to receive either two doses of daclizumab (1 mg/kg) and, for the first 3 days, 100 mg of prednisolone (daclizumab group n = 186), or steroids (tapered to 0 mg at week 16; controls n = 178). All patients received tacrolimus and MMF. The incidence of biopsy-confirmed acute rejection at 12 months was not different between the daclizumab group (15%) and the controls (14%) (95% confidence interval of difference: -6 to + 8%, NS). Graft survival at 12 months was comparable in the two groups (daclizumab group: 91%; controls: 90%). Mean arterial blood pressure, serum lipids, and incidence of patients with hyperglycemia were temporary lower in the daclizumab group compared with controls. The immunosuppressive regimen of the daclizumab group was associated with increased costs. In conclusion, with the use of anti-IL-2Ra induction and daily therapy with tacrolimus and MMF it is feasible to withdraw steroids at 3 days after renal transplantation.
肾移植后的大多数免疫抑制方案中都包含类固醇，但因其副作用而令人担忧。我们进行了一项前瞻性多中心研究，以调查在使用抗IL-2Rα诱导剂、他克莫司和霉酚酸酯（MMF）的情况下，移植后早期停用类固醇是否可行。共有364例患者被随机分为两组，一组接受两剂达利珠单抗（1 mg/kg），并在开始的3天内每日服用100 mg泼尼松龙（达利珠单抗组，n = 186），另一组接受类固醇治疗（在第16周逐渐减至0 mg；对照组，n = 178）。所有患者均接受他克莫司和MMF治疗。达利珠单抗组和对照组在12个月时经活检证实的急性排斥反应发生率无差异（达利珠单抗组为15%，对照组为14%）（差异的95%置信区间：-6%至+8%，无显著性差异）。两组在12个月时的移植物存活率相当（达利珠单抗组：91%；对照组：90%）。与对照组相比，达利珠单抗组的平均动脉血压、血脂以及高血糖患者的发生率暂时较低。达利珠单抗组的免疫抑制方案成本较高。总之，在使用抗IL-2Rα诱导剂以及他克莫司和MMF每日治疗的情况下，肾移植后3天停用类固醇是可行的。
