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左心室射血分数的测量是否是细胞治疗试验的合适终点?通过心脏磁共振成像评估骨髓单个核干细胞治疗 ST 段抬高型心肌梗死后左心室射血分数的效果分析。

Is the measurement of left ventricular ejection fraction the proper end point for cell therapy trials? An analysis of the effect of bone marrow mononuclear stem cell administration on left ventricular ejection fraction after ST-segment elevation myocardial infarction when evaluated by cardiac magnetic resonance imaging.

机构信息

The Minneapolis Heart Institute at Abbott Northwestern Hospital, MN 55407, USA.

出版信息

Am Heart J. 2011 Oct;162(4):671-7. doi: 10.1016/j.ahj.2011.06.019.

DOI:10.1016/j.ahj.2011.06.019
PMID:21982659
Abstract

BACKGROUND

The measurement of left ventricular (LV) ejection fraction (LVEF) is a strong predictor of cardiovascular adverse events and mortality in patients with LV dysfunction and has become the most common primary end point in cardiovascular cell therapy trials after ST-segment elevation myocardial infarction (STEMI). Multiple small trials have been performed using bone marrow mononuclear stem cells (BMCs) in this setting with several meta-analyses demonstrating that BMC administration results in a small improvement in LVEF and may attenuate adverse LV remodeling. However, individual trial results have not been uniform, and the measurement of LVEF in these trials has relied on a variety of imaging techniques including LV angiograpnhy, single-photon emission computed tomography, echocardiography, or cardiac magnetic resonance imaging (cMRI).

METHODS

Because cMRI provides the most accurate measurement of LVEF, LV volumes, and infarct size in patients after STEMI, we reviewed all randomized cardiovascular stem cell trials (N = 10) that administered intracoronary BMCs versus placebo/control to 686 patients after primary percutaneous coronary intervention treatment of STEMI that used cMRI as their principal imaging measurement of LVEF at baseline and 3 to 6 months later.

RESULTS

Administration of BMCs was associated with a nonsignificant 0.9% ± 0.8% absolute increase in LVEF compared with placebo or control (95% CI -0.7 to 2.4) with a small but nonsignificant decrease LV end-diastolic and LV end-systolic volumes (LV end-diastolic volume -1.1 ± 1.5 mL/m(2), LV end-systolic volume -1.6 ± 1.4 mL/m(2)). Although infarct size uniformly decreased over time, the reduction was not improved by BMC administration (-0.3 ± 1.7 g).

CONCLUSIONS

The benefit of BMC administration after STEMI on LVEF, LV volumes, and infarct size is small when assessed by cMRI.

摘要

背景

左心室(LV)射血分数(LVEF)的测量是 LV 功能障碍患者心血管不良事件和死亡率的强有力预测指标,并且在 ST 段抬高型心肌梗死(STEMI)后已成为心血管细胞治疗试验中最常见的主要终点。在这种情况下,已经进行了多项使用骨髓单核干细胞(BMC)的小型试验,几项荟萃分析表明,BMC 给药可导致 LVEF 略有改善,并可能减轻 LV 重构的不良影响。然而,个别试验结果并不一致,并且这些试验中的 LVEF 测量依赖于多种成像技术,包括 LV 血管造影、单光子发射计算机断层扫描、超声心动图或心脏磁共振成像(cMRI)。

方法

由于 cMRI 可在 STEMI 后患者中提供 LVEF、LV 容积和梗死面积的最准确测量,我们回顾了所有随机心血管干细胞试验(N=10),这些试验将经皮冠状动脉介入治疗 STEMI 后的患者随机分为冠状动脉内 BMC 组与安慰剂/对照组,共 686 例患者,这些试验均使用 cMRI 作为基线和 3 至 6 个月后 LVEF 的主要成像测量。

结果

与安慰剂或对照组相比,BMC 给药与 LVEF 绝对值增加 0.9%±0.8%(95%CI-0.7 至 2.4)相关,LV 舒张末期和 LV 收缩末期容积略有但无统计学意义的降低(LV 舒张末期容积-1.1±1.5mL/m2,LV 收缩末期容积-1.6±1.4mL/m2)。尽管梗死面积随时间均匀减小,但 BMC 给药并未改善梗死面积的减少(-0.3±1.7g)。

结论

通过 cMRI 评估,STEMI 后 BMC 给药对 LVEF、LV 容积和梗死面积的益处较小。

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