Wollert Kai C, Meyer Gerd P, Lotz Joachim, Ringes-Lichtenberg Stefanie, Lippolt Peter, Breidenbach Christiane, Fichtner Stephanie, Korte Thomas, Hornig Burkhard, Messinger Diethelm, Arseniev Lubomir, Hertenstein Bernd, Ganser Arnold, Drexler Helmut
Department of Cardiology, Hanover Medical School, Hanover, Germany.
Lancet. 2004;364(9429):141-8. doi: 10.1016/S0140-6736(04)16626-9.
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aimed to assess whether intracoronary transfer of autologous bone-marrow cells could improve global left-ventricular ejection fraction (LVEF) at 6 months' follow-up.
After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction, 60 patients were randomly assigned to either a control group (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4.8 days (SD 1.3) after PCI. Primary endpoint was global left-ventricular ejection fraction (LVEF) change from baseline to 6 months' follow-up, as determined by cardiac MRI. Image analyses were done by two investigators blinded for treatment assignment. Analysis was per protocol.
Global LVEF at baseline (determined 3.5 days [SD 1.5] after PCI) was 51.3 (9.3%) in controls and 50.0 (10.0%) in the bone-marrow cell group (p=0.59). After 6 months, mean global LVEF had increased by 0.7 percentage points in the control group and 6.7 percentage points in the bone-marrow-cell group (p=0.0026). Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk of adverse clinical events, in-stent restenosis, or proarrhythmic effects.
Intracoronary transfer of autologous bone-marrow-cells promotes improvement of left-ventricular systolic function in patients after acute myocardial infarction.
新出现的证据表明，源自骨髓的干细胞和祖细胞可用于改善急性心肌梗死后患者的心脏功能。在这项随机试验中，我们旨在评估自体骨髓细胞冠状动脉内移植能否在6个月的随访中改善整体左心室射血分数（LVEF）。
在对急性ST段抬高型心肌梗死成功进行经皮冠状动脉介入治疗（PCI）后，60例患者被随机分配至对照组（n = 30），接受最佳的梗死后药物治疗；或骨髓细胞组（n = 30），接受最佳药物治疗并在PCI后4.8天（标准差1.3）进行自体骨髓细胞冠状动脉内移植。主要终点是通过心脏磁共振成像确定的从基线到6个月随访时的整体左心室射血分数（LVEF）变化。图像分析由两名对治疗分配不知情的研究人员进行。分析按照方案进行。
对照组在基线时（PCI后3.5天[标准差1.5]测定）的整体LVEF为51.3（9.3%），骨髓细胞组为50.0（10.0%）（p = 0.59）。6个月后，对照组的平均整体LVEF增加了0.7个百分点，骨髓细胞组增加了6.7个百分点（p = 0.0026）。骨髓细胞移植主要增强了梗死区域附近心肌节段的左心室收缩功能。细胞移植未增加不良临床事件、支架内再狭窄或促心律失常作用的风险。
自体骨髓细胞冠状动脉内移植可促进急性心肌梗死后患者左心室收缩功能的改善。
