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肾移植后最初几周内使用高剂量促红细胞生成素β和延迟移植物功能:Neo-PDGF 研究的结果。

High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study.

机构信息

Hôpital Necker, Assistance Publique Hôpitaux de Paris et Université Paris Descartes, France.

出版信息

Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.

DOI:10.1111/j.1600-6143.2010.03142.x
PMID:20642691
Abstract

Erythropoietin promotes nephroprotection in animal models of ischemia-reperfusion injury. Neorecormon and Prevention of Delayed Graft Function (Neo-PDGF) is a French open-label multicenter randomized study to evaluate the effect of high doses of epoetin beta (EPO-beta) during the first 2 weeks of renal transplantation on renal function in patients at risk for delayed graft function (DGF). One hundred and four patients were included in the study. Patients randomized in treatment group (A) received four injections of EPO-beta (30.000 UI each), given before surgery and at 12 h, 7 days and 14 days posttransplantation. Patients randomized in control group (B) did not receive EPO-beta. Immunosuppression included induction with basiliximab and maintenance therapy with steroids, mycophenolate mofetil and tacrolimus. At 1 month posttransplant, the estimated glomerular filtration rate (MDRD formula) was 42.5 +/- 19.0 mL/min in the EPO-beta group and 44.0 +/- 16.3 mL/min in the control group (p = ns). The frequency of DGF was similar in both groups (32% vs. 38.8%; p = ns). No difference in the incidence of serious adverse events was observed. (ClinicalTrials.gov number, NCT00815867.).

摘要

促红细胞生成素可促进动物模型缺血再灌注损伤的肾脏保护。Neorecormon 和预防移植肾功能延迟恢复(Neo-PDGF)是一项法国开放性标签多中心随机研究,旨在评估在移植后前 2 周内使用高剂量促红细胞生成素β(EPO-β)对有移植肾功能延迟恢复(DGF)风险的患者的肾功能的影响。该研究纳入了 104 例患者。治疗组(A 组)的患者接受了 4 次 EPO-β(每次 30,000 UI)的注射,分别在术前、术后 12 小时、7 天和 14 天给予。对照组(B 组)的患者未接受 EPO-β治疗。免疫抑制方案包括巴利昔单抗诱导和类固醇、霉酚酸酯和他克莫司维持治疗。移植后 1 个月时,EPO-β组的估计肾小球滤过率(MDRD 公式)为 42.5±19.0mL/min,对照组为 44.0±16.3mL/min(p=ns)。两组 DGF 的发生率相似(32%比 38.8%;p=ns)。未观察到严重不良事件发生率的差异。(ClinicalTrials.gov 编号:NCT00815867)。

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