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接受直接经皮冠状动脉介入治疗的急性 ST 段抬高型心肌梗死患者的红细胞生成素:一项随机、双盲试验。

Erythropoietin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized, double-blind trial.

机构信息

1. Medizinische Klinik rechts der Isar, Munich, Germany.

出版信息

Circ Cardiovasc Interv. 2010 Oct;3(5):408-13. doi: 10.1161/CIRCINTERVENTIONS.109.904425. Epub 2010 Aug 24.

DOI:10.1161/CIRCINTERVENTIONS.109.904425
PMID:20736448
Abstract

BACKGROUND

Erythropoietin improves myocardial function in experimental models of myocardial infarction. The aim of the present study was to determine the value of erythropoietin in patients with acute ST-elevation myocardial infarction.

METHODS AND RESULTS

This randomized, double-blind study included 138 patients admitted with acute ST-elevation myocardial infarction and treated with primary percutaneous coronary intervention. Patients were randomly assigned to receive epoetin-β (3.33×104 U, n=68) or placebo (n=70) immediately and at 24 and 48 hours after percutaneous coronary intervention. The primary end point was left ventricular ejection fraction after 6 months measured by MRI. Other end points included infarct size at 5 days and 6 months. Clinical adverse events (death, recurrent myocardial infarction, stroke, and infarct-related artery revascularization) were investigated at 30 days and 6 months. Left ventricular ejection fraction at 6-month follow-up was 52.0±9.1% in the erythropoietin group compared with 51.8±9.3% in the placebo group (P=0.92). Five days after percutaneous coronary intervention, left ventricular ejection fraction was 49.4±8.0% in the erythropoietin group and 50.8±7.3% in the placebo group (P=0.32); infarct size was 26.8±20.9% and 28.3±24.4% (P=0.76) and decreased to 17.3±14.3% and 20.9±16.4% at 6-month follow-up (P=0.27). The cumulative 6-month incidence of death, recurrent myocardial infarction, stroke or target vessel revascularization was 13.2% in the erythropoietin group and 5.7% in the placebo group (hazard ratio, 2.36; 95% confidence interval, 0.73 to 7.66; P=0.15).

CONCLUSIONS

In patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention, erythropoietin treatment did not improve left ventricular ejection fraction or reduce infarct size but may increase clinical adverse events.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00390832.

摘要

背景

促红细胞生成素可改善实验性心肌梗死模型中的心肌功能。本研究旨在确定促红细胞生成素在急性 ST 段抬高型心肌梗死患者中的价值。

方法和结果

这是一项随机、双盲研究,共纳入 138 例因急性 ST 段抬高型心肌梗死接受经皮冠状动脉介入治疗的患者。患者被随机分配至即刻以及经皮冠状动脉介入治疗后 24 小时和 48 小时接受促红细胞生成素-β(3.33×104 U,n=68)或安慰剂(n=70)治疗。主要终点为 MRI 检查 6 个月时的左心室射血分数。其他终点包括 5 天和 6 个月时的梗死面积。30 天和 6 个月时评估临床不良事件(死亡、再发心肌梗死、卒中和梗死相关动脉血运重建)。促红细胞生成素组 6 个月随访时的左心室射血分数为 52.0±9.1%,安慰剂组为 51.8±9.3%(P=0.92)。经皮冠状动脉介入治疗后 5 天,促红细胞生成素组的左心室射血分数为 49.4±8.0%,安慰剂组为 50.8±7.3%(P=0.32);梗死面积分别为 26.8±20.9%和 28.3±24.4%(P=0.76),6 个月随访时分别为 17.3±14.3%和 20.9±16.4%(P=0.27)。促红细胞生成素组 6 个月的死亡率、再发心肌梗死、卒中和靶血管血运重建的累积发生率为 13.2%,安慰剂组为 5.7%(风险比,2.36;95%置信区间,0.73 至 7.66;P=0.15)。

结论

在接受经皮冠状动脉介入治疗的急性 ST 段抬高型心肌梗死患者中,促红细胞生成素治疗并未改善左心室射血分数或减少梗死面积,但可能增加临床不良事件。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00390832。

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