Lipsic Erik, van der Meer Peter, Voors Adriaan A, Westenbrink B Daan, van den Heuvel Ad F M, de Boer Hetty C, van Zonneveld Anton J, Schoemaker Regien G, van Gilst Wiek H, Zijlstra Felix, van Veldhuisen Dirk J
Department of Cardiology, University Medical Center Groningen, University of Groningen, The Netherlands.
Cardiovasc Drugs Ther. 2006 Apr;20(2):135-41. doi: 10.1007/s10557-006-7680-5.
Besides stimulating hematopoiesis, erythropoietin (EPO) protects against experimental ischemic injury in the heart. The present study evaluated the safety and tolerability of EPO treatment in non-anemic patients with acute myocardial infarction (MI).
In this single-center, investigator-initiated, prospective study, patients with a first acute MI were randomized to one bolus of 300 microg darbepoetin alfa or no additional medication before primary coronary intervention. Twenty-two patients (mean age 59 +/- 2 years) were included. In the darbepoetin group, serum EPO-levels increased to 130-270 times that of controls, within the first 24 h. After darbepoetin administration, only small and non-significant changes in hematocrit levels were observed, while endothelial progenitor cells (EPCs, CD34+/CD45-) were increased at 72 h (2.8 vs. 1.0 cells/microl in control group, p < 0.01). No adverse events were recorded during the 30-day follow-up. After 4 months, left ventricular ejection fraction was similar in the two groups (52 +/- 3% in darbepoetin vs. 48 +/- 5% in control group, p = NS).
Intravenous single high-dose darbepoetin alfa in acute MI is both safe and well tolerated. Darbepoetin treatment after MI stimulates EPCs mobilization. The results of this first pilot study support a larger scale clinical trial to establish efficacy of EPO administration in patients after acute MI.
除了刺激造血外，促红细胞生成素（EPO）还可保护心脏免受实验性缺血损伤。本研究评估了EPO治疗在非贫血急性心肌梗死（MI）患者中的安全性和耐受性。
在这项单中心、研究者发起的前瞻性研究中，首次发生急性MI的患者在接受初次冠状动脉介入治疗前被随机分为接受一次300微克的阿法达贝泊汀推注或不接受额外药物治疗。纳入了22名患者（平均年龄59±2岁）。在阿法达贝泊汀组中，血清EPO水平在最初24小时内升至对照组的130 - 270倍。给予阿法达贝泊汀后，仅观察到血细胞比容水平有微小且无统计学意义的变化，而内皮祖细胞（EPCs，CD34+/CD45-）在72小时时增加（对照组为1.0个细胞/微升，阿法达贝泊汀组为2.8个细胞/微升，p<0.01）。在30天的随访期间未记录到不良事件。4个月后，两组的左心室射血分数相似（阿法达贝泊汀组为52±3%，对照组为48±5%，p=无显著性差异）。
急性MI患者静脉注射单次高剂量阿法达贝泊汀既安全又耐受性良好。MI后给予阿法达贝泊汀治疗可刺激EPCs动员。这项首次试点研究的结果支持进行更大规模的临床试验以确定EPO给药对急性MI后患者的疗效。
