Gelens Marielle A C J, Christiaans Maarten H L, van Heurn Ernst L W, van den Berg-Loonen Ella P M, Peutz-Kootstra Carine J, van Hooff Johannes P
Department of Internal Medicine, University Hospital Maastricht, the Netherlands.
Transplantation. 2006 Nov 15;82(9):1221-3. doi: 10.1097/01.tp.0000232688.76018.19.
Morbidity and mortality due to cardiovascular disease are major problems after renal transplantation. The effects of three immunosuppressive protocols on cardiovascular end points were investigated in a single-center, randomized, parallel (1-1-1) group. Acute rejection was a secondary safety endpoint. Groups were as follows: group one, tacrolimus+sirolimus; group two, tacrolimus+mycophenolate mofetil (MMF); group three, sirolimus+MMF+daclizumab. All groups received two days methylprednisolone only. The Ethical Committee demanded an interim analysis when 50% of the patients were included. In this analysis, 54 patients with a median follow-up of 9.2 months were studied. The Kaplan-Meyer analysis showed a difference in rejection free survival between group one (82%) and group three (34%, P=0.03) and between groups one and two (tacrolimus-based, 76%) and group three (calcineurin-free, 34%, P=0.04). Calcineurin-free immunosuppression with two days of steroids only showed an unacceptable high incidence of acute rejection and re-rejection, and the study had to be stopped.
肾移植后，心血管疾病导致的发病率和死亡率是主要问题。在一个单中心、随机、平行（1-1-1）组中，研究了三种免疫抑制方案对心血管终点的影响。急性排斥反应是次要安全终点。分组如下：一组，他克莫司+西罗莫司；二组，他克莫司+霉酚酸酯（MMF）；三组，西罗莫司+MMF+达利珠单抗。所有组仅接受两天的甲泼尼龙治疗。伦理委员会要求在纳入50%的患者时进行中期分析。在此分析中，研究了54例患者，中位随访时间为9.2个月。Kaplan-Meyer分析显示，一组（82%）和三组（34%，P=0.03）之间以及一组和二组（基于他克莫司，76%）与三组（无钙调神经磷酸酶，34%，P=0.04）之间在无排斥反应生存方面存在差异。仅使用两天类固醇的无钙调神经磷酸酶免疫抑制显示急性排斥反应和再次排斥反应的发生率高得令人无法接受，该研究不得不停止。
