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单次静脉注射重组人红细胞生成素治疗急性心肌梗死患者具有广阔前景——EPO/AMI-1 研究的随机对照试验

Single-dose intravenous administration of recombinant human erythropoietin is a promising treatment for patients with acute myocardial infarction - randomized controlled pilot trial of EPO/AMI-1 study -.

机构信息

First Department of Internal Medicine, Niigata University Medical and Dental Hospital, Niigata, Japan.

出版信息

Circ J. 2010 Jul;74(7):1415-23. doi: 10.1253/circj.cj-10-0109. Epub 2010 May 22.

DOI:10.1253/circj.cj-10-0109
PMID:20501957
Abstract

BACKGROUND

Erythropoietin (EPO) has been found to have anti-apoptotic and tissue protective effects on the myocardium. The aim of the present pilot study was to observe the safety and efficacy of EPO administration for patients with acute myocardial infarction (AMI).

METHODS AND RESULTS

Patients admitted with AMI had all undergone successful percutaneous coronary intervention (PCI). Patients were randomly assigned to 2 groups (control and EPO groups), and given 12,000 IU EPO iv or saline after PCI. The primary endpoints were the difference between the acute phase and chronic phase (6 months after the attack) regarding left ventricular function as measured on electrocardiogram-gated single-photon emission computed tomography. Thirty-six patients (control 16, EPO 20) were eligible for analysis. Left ventricular ejection fraction (LVEF) significantly increased in the EPO group (from 51.0+/-19.6% to 58.5+/-15.0%, P=0.0238), but not in the control group. Further analysis was separately undertaken in patients with occlusion in the left anterior descending artery (LAD) and others (non-LAD). LVEF was <50% in most patients in the LAD subgroup, and LVEF significantly increased in the EPO group (37.5+/-13.0 to 52.7+/-15.8, P=0.0049), but not in the control group. EPO administration did not trigger any adverse clinical events.

CONCLUSIONS

EPO administration is a promising treatment for AMI.

摘要

背景

促红细胞生成素(EPO)已被发现对心肌具有抗凋亡和组织保护作用。本初步研究的目的是观察 EPO 给药治疗急性心肌梗死(AMI)患者的安全性和疗效。

方法和结果

接受 AMI 治疗的患者均成功接受经皮冠状动脉介入治疗(PCI)。患者被随机分配到 2 组(对照组和 EPO 组),并在 PCI 后给予 12000IU EPO 静脉注射或生理盐水。主要终点是心电图门控单光子发射计算机断层扫描测量的左心室功能在急性期和慢性期(发病后 6 个月)之间的差异。36 例患者(对照组 16 例,EPO 组 20 例)符合分析条件。EPO 组左心室射血分数(LVEF)显著增加(从 51.0±19.6%增加至 58.5±15.0%,P=0.0238),但对照组没有。进一步在左前降支(LAD)闭塞和其他(非-LAD)患者中分别进行分析。LAD 亚组的大多数患者 LVEF<50%,EPO 组 LVEF 显著增加(从 37.5±13.0%增加至 52.7±15.8%,P=0.0049),但对照组没有。EPO 给药没有引发任何不良临床事件。

结论

EPO 给药是治疗 AMI 的一种有前途的方法。

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