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心肌梗死后早期和晚期联合递送骨髓单个核干细胞:MYSTAR前瞻性随机研究

Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction: the MYSTAR prospective, randomized study.

作者信息

Gyöngyösi Mariann, Lang Irene, Dettke Markus, Beran Gilbert, Graf Senta, Sochor Heinz, Nyolczas Noémi, Charwat Silvia, Hemetsberger Rayyan, Christ Günter, Edes István, Balogh László, Krause Korff Thomas, Jaquet Kai, Kuck Karl-Heinz, Benedek Imre, Hintea Theodora, Kiss Róbert, Préda István, Kotevski Vladimir, Pejkov Hristo, Zamini Sholeh, Khorsand Aliasghar, Sodeck Gottfried, Kaider Alexandra, Maurer Gerald, Glogar Dietmar

机构信息

Department of Cardiology, Medical University of Vienna, Austria.

出版信息

Nat Clin Pract Cardiovasc Med. 2009 Jan;6(1):70-81. doi: 10.1038/ncpcardio1388. Epub 2008 Nov 11.

DOI:10.1038/ncpcardio1388
PMID:19002124
Abstract

BACKGROUND

Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction (AMI). We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches.

METHODS

Patients with left ventricular ejection fraction less than 45% after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI. Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy.

RESULTS

A total of 60 patients were treated. The mean changes in infarct size at 3 months were -3.5 +/- 5.1% (95% CI -5.5% to -1.5%, P = 0.001) in the early group and -3.9 +/- 5.6% (95% CI -6.1% to -1.6%, P = 0.002) in the late group, and changes in ejection fraction were 3.5 +/- 5.6% (95% CI 1.3-5.6%, P = 0.003) and 3.4 +/- 7.0% (95% CI 0.7-6.1%, P = 0.017), respectively. At 9-12 months after AMI, ejection fraction remained significantly higher than at baseline in both groups. In the early and late groups, a mean of 200.3 +/- 68.7 x 10(6) and 194.8 +/- 60.4 x 10(6) stem cells, respectively, were delivered to the myocardium, and 1.30 +/- 0.68 x 10(9) and 1.29 +/- 0.41 x 10(9) cells, respectively, were delivered into the artery. A high number of cells was required for significant improvements in the primary end points.

CONCLUSIONS

Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function.

摘要

背景

冠状动脉内和心肌内联合给药可能会改善急性心肌梗死(AMI)的骨髓源性干细胞治疗效果。我们比较了干细胞早期和晚期递送联合治疗方法的安全性和可行性。

方法

急性心肌梗死后左心室射血分数小于45%的患者被随机分配在急性心肌梗死后3 - 6周或3 - 4个月通过心肌内注射和冠状动脉内输注进行干细胞递送。主要终点是治疗后3个月梗死面积和左心室射血分数的变化。

结果

共治疗60例患者。早期组3个月时梗死面积的平均变化为-3.5±5.1%(95%CI -5.5%至-1.5%,P = 0.001),晚期组为-3.9±5.6%(95%CI -6.1%至-1.6%,P = 0.002),射血分数变化分别为3.5±5.6%(95%CI 1.3 - 5.6%,P = 0.003)和3.4±7.0%(95%CI 0.7 - 6.1%,P = 0.017)。急性心肌梗死后9 - 12个月,两组射血分数仍显著高于基线水平。早期组和晚期组分别平均向心肌递送200.3±68.7×10⁶和194.8±60.4×10⁶个干细胞,分别向动脉内递送1.30±0.68×10⁹和1.29±0.41×10⁹个细胞。主要终点有显著改善需要大量细胞。

结论

联合心脏干细胞递送可使心肌梗死面积和左心室功能有中度但显著的改善。

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