Department of Internal Medicine, Hannover Medical School, Hannover, Germany.
Kidney Int. 2012 Feb;81(3):314-20. doi: 10.1038/ki.2011.349. Epub 2011 Oct 19.
We evaluated short- and long-term effects of high-dose recombinant human erythropoietin (rHuEPO) in kidney transplantation in a prospective double-blind, placebo-controlled study. Patients with chronic kidney disease following receipt of a deceased donor kidney allograft were randomized to 3 doses of 40,000 units rHuEPO or placebo. The primary study end point was kidney function 6 weeks after transplantation with secondary end points of incidence of delayed graft function and kidney function 12 months after transplantation. Six weeks or 12 months after transplantation, the difference between estimated glomerular filtration rates was not significant comparing 44 patients who received rHuEPO to 44 patients receiving placebo. There was no significant difference regarding the incidence of delayed graft function (10 of 44 with rHuEPO compared with 14 of 44 on placebo). Protocol biopsies at 6 weeks and 6 months post transplant showed no significant differences in all assessed histological indices. The number and severity of adverse events were comparable between groups, as was patient and graft survival after 12 months. Thus, treatment with high-dose rHuEPO after kidney transplantation, although well tolerated, had no effect on long-term graft function or histology.
我们在一项前瞻性、双盲、安慰剂对照研究中评估了高剂量重组人红细胞生成素(rHuEPO)在肾移植中的短期和长期效果。接受已故供体肾移植的慢性肾脏病患者被随机分为 3 组,分别接受 40000 单位 rHuEPO 或安慰剂。主要研究终点为移植后 6 周的肾功能,次要终点为延迟移植物功能和移植后 12 个月的肾功能。在移植后 6 周或 12 个月时,接受 rHuEPO 的 44 例患者与接受安慰剂的 44 例患者之间估计肾小球滤过率的差异无统计学意义。接受 rHuEPO 的 44 例患者与接受安慰剂的 44 例患者中,延迟移植物功能的发生率(10 例与 14 例)无显著差异。移植后 6 周和 6 个月的方案活检显示,所有评估的组织学指标均无显著差异。两组之间的不良事件数量和严重程度相当,12 个月后患者和移植物的存活率也相当。因此,肾移植后使用高剂量 rHuEPO 治疗虽然耐受良好,但对长期移植物功能或组织学没有影响。