University of Oulu, Department of Internal Medicine. P.O. Box 5000 (Kajaanintie 50), FIN-90014 University of Oulu, Oulu, Finland.
Heart. 2010 Mar;96(5):362-7. doi: 10.1136/hrt.2009.171694. Epub 2009 Nov 11.
To assess the determinants of functional recovery in patients with ST-elevation myocardial infarction (STEMI) treated initially with thrombolysis, followed by percutaneous coronary intervention and intracoronary injection of bone marrow-derived stem cells (BMC).
A randomised, placebo-controlled, double-blind study (substudy of FINCELL).
Two tertiary cardiac centres.
78 patients with STEMI randomly assigned to receive either intracoronary BMC (n=39) or placebo (n=39) into the infarct-related artery.
Thrombolysis a few hours after symptom onset, percutaneous coronary intervention and intracoronary injection of BMC 2-6 days later.
Efficacy of the BMC treatment was assessed by measurement of the change of global left ventricular ejection fraction (LVEF) from baseline to 6 months after STEMI. Various predefined variables (eg, the levels of certain natriuretic peptides and inflammatory cytokines) were analysed as determinants of improvement of LVEF.
In the BMC group, the most powerful determinant of the change in LVEF was the baseline LVEF (r=-0.58, p<0.001). Patients with baseline LVEF at or below the median (< or = 62.5%) experienced a more marked improvement in LVEF (+12.7 + or - 12.5 %units, p<0.001) than those above the median (-0.8 + or - 6.3 %units, p=0.10). Elevated N-terminal probrain natriuretic peptide (p<0.001) and N-terminal proatrial natriuretic peptide (p=0.052) levels were also associated with improvement in LVEF in the BMC group but not in the placebo group.
The global LVEF recovers most significantly after intracoronary infusion of BMC in patients with the most severe impairment of LVEF on admission. The baseline levels of natriuretic peptides seem also to be associated with LVEF recovery after BMC treatment. Trial registration ClinicalTrials.gov number, NCT00363324.
评估初始接受溶栓治疗，随后行经皮冠状动脉介入治疗和冠状动脉内注射骨髓源性干细胞（BMC）的 ST 段抬高型心肌梗死（STEMI）患者的功能恢复的决定因素。
随机、安慰剂对照、双盲研究（FINCELL 子研究）。
两个三级心脏中心。
78 例 STEMI 患者，随机分配接受冠状动脉内 BMC（n=39）或安慰剂（n=39）注入梗死相关动脉。
溶栓治疗在症状发作后数小时内进行，经皮冠状动脉介入治疗和冠状动脉内注射 BMC 在 2-6 天后进行。
通过测量 STEMI 后 6 个月时的左心室整体射血分数（LVEF）变化评估 BMC 治疗的疗效。分析了各种预设变量（如某些利钠肽和炎性细胞因子的水平）作为 LVEF 改善的决定因素。
在 BMC 组中，LVEF 变化的最强决定因素是基线 LVEF（r=-0.58，p<0.001）。基线 LVEF 等于或低于中位数（<或=62.5%）的患者，LVEF 的改善更为显著（+12.7+或-12.5%单位，p<0.001），而基线 LVEF 高于中位数（-0.8+或-6.3%单位，p=0.10）的患者则不然。BMC 组中升高的 N 末端脑利钠肽前体（p<0.001）和 N 末端 proatrial 利钠肽（p=0.052）水平也与 LVEF 的改善相关，但在安慰剂组中则不然。
在接受溶栓治疗的患者中，冠状动脉内输注 BMC 后，LVEF 的恢复最为显著，入院时 LVEF 损伤最严重。利钠肽的基线水平似乎也与 BMC 治疗后的 LVEF 恢复有关。
ClinicalTrials.gov 编号，NCT00363324。
