急性心肌梗死后行直接经皮冠状动脉介入治疗患者中，与标准治疗相比，骨髓或外周血单核细胞冠状动脉内输注：随机对照 HEBE 试验的结果。

Intracoronary infusion of mononuclear cells from bone marrow or peripheral blood compared with standard therapy in patients after acute myocardial infarction treated by primary percutaneous coronary intervention: results of the randomized controlled HEBE trial.

机构信息

Department of Cardiology, Academic Medical Center, University of Amsterdam, PO Box 22660, 1100 DD Amsterdam, The Netherlands.

出版信息

Eur Heart J. 2011 Jul;32(14):1736-47. doi: 10.1093/eurheartj/ehq449. Epub 2010 Dec 10.

DOI:10.1093/eurheartj/ehq449

PMID:21148540

Abstract

AIMS

Previous trials that investigated cell therapy as an adjunctive therapy after acute myocardial infarction (AMI) have shown conflicting results. We designed a randomized controlled trial to determine the effect of intracoronary infusion of mononuclear cells from bone marrow (BM) or peripheral blood in patients with AMI.

METHODS AND RESULTS

In a multicentre trial, 200 patients with large first AMI treated with primary percutaneous coronary intervention were randomly assigned to either intracoronary infusion of mononuclear BM cells (n = 69), mononuclear peripheral blood cells (n = 66), or standard therapy (without placebo infusion) (n = 65). Mononuclear cells were delivered intracoronary between 3 and 8 days after AMI. Regional and global left ventricular myocardial function and volumes were assessed by magnetic resonance imaging before randomization and at 4 months, and clinical events were reported. The primary endpoint of the percentage of dysfunctional left ventricular segments that improved during follow-up did not differ significantly between either of the treatment groups and control: 38.6 ± 24.7% in the BM group, 36.8 ± 20.9% in the peripheral blood group, and 42.4 ± 18.7% in the control group (P = 0.33 and P = 0.14). Improvement of left ventricular ejection fraction was 3.8 ± 7.4% in the BM group, 4.2 ± 6.2% in the peripheral blood group when compared with 4.0 ± 5.8% in the control group (P = 0.94 and P = 0.90). Furthermore, the three groups did not differ significantly in changes in left ventricular volumes, mass, and infarct size and had similar rates of clinical events.

CONCLUSION

Intracoronary infusion of mononuclear cells from BM or peripheral blood following AMI does not improve regional or global systolic myocardial function in the HEBE trial.

REGISTRATION

The Netherlands Trial Register #NTR166 (www.trialregister.nl) and the International Standard Randomised Controlled Trial, #ISRCTN95796863 (http://isrctn.org).

摘要

目的

先前的临床试验表明，细胞疗法作为急性心肌梗死（AMI）后的辅助治疗，结果存在矛盾。我们设计了一项随机对照试验，以确定在 AMI 患者中经冠状动脉输注骨髓（BM）或外周血单核细胞的效果。

方法和结果

在一项多中心试验中，200 例接受首次 AMI 经皮冠状动脉介入治疗的患者被随机分为三组：经冠状动脉输注 BM 单核细胞（n=69）、外周血单核细胞（n=66）或标准治疗（无安慰剂输注）（n=65）。在 AMI 后 3 至 8 天经冠状动脉输注单核细胞。在随机分组前和 4 个月时，通过磁共振成像评估局部和整体左心室心肌功能和容积，并报告临床事件。随访期间左心室节段功能改善的比例（主要终点）在治疗组和对照组之间没有显著差异：BM 组为 38.6±24.7%，外周血组为 36.8±20.9%，对照组为 42.4±18.7%（P=0.33 和 P=0.14）。与对照组（P=0.94 和 P=0.90）相比，BM 组的左心室射血分数改善为 3.8±7.4%，外周血组为 4.2±6.2%。此外，三组在左心室容积、质量和梗死面积的变化方面没有显著差异，临床事件发生率也相似。