A single bolus of a long-acting erythropoietin analogue darbepoetin alfa in patients with acute myocardial infarction: A randomized feasibility and safety study
A single bolus of a long-acting erythropoietin analogue darbepoetin alfa in patients with acute myocardial infarction: A randomized feasibility and safety study
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DOI：
10.1007/s10557-006-7680-5
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发表时间：
2006-04-01
影响因子：
3.4
通讯作者：
van Veldhuisen, Dirk J.
中科院分区：
文献类型：
--
作者：
Lipsic, Erik;van der Meer, Peter;van Veldhuisen, Dirk J.
目的：促红细胞生成素(EPO)除了能刺激造血外，还能保护心脏免受实验性的缺血损伤。评价促红细胞生成素治疗急性心肌梗死患者的安全性和耐受性。方法和结果：在这项单中心、研究者发起的前瞻性研究中，首次急性心肌梗死患者被随机分为两组，一组在直接冠状动脉介入治疗前服用300mg达贝泊丁阿尔法，另一组不加药。22例患者(平均年龄59±2岁)纳入研究。在给药后的24小时内，血清EPO水平上升到对照组的130-270倍，在给药后72小时，红细胞压积仅有很小且无明显变化，而内皮祖细胞(EPC，CD34+/CD45-)明显升高(对照组为1.0个/亩L，P<0.01)。在30天的随访中，没有记录到不良事件。4个月后，两组左心室射血分数相似(达贝泊丁组为52+/-3%，对照组为48+/-5%，P=NS)。结论：大剂量达贝泊松单次静脉滴注治疗急性心肌梗死安全、耐受性好。心肌梗死后达贝泊丁治疗可刺激内皮祖细胞动员。这第一项先导性研究的结果支持了一项更大规模的临床试验，以确定EPO对急性心肌梗死患者的疗效。
Aims: Besides stimulating hematopoiesis, erythro-poietin (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).Methods and Results: In this single-center, investigator-initiated, prospective study, patients with a first acute MI were randomized to one bolus of 300 mu g 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 nonsignificant changes in hematocrit levels were observed, while endothelial progenitor cells (EPCs, CD34+/CD45-) were increased at 72 h (2.8 vs. 1.0 cells/mu l 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).Conclusions: 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.