自体骨髓单个核细胞移植治疗急性心肌梗死的疗效与安全性随机对照研究

The Efficacy and safety of autologous bone marrow mononuclear cells transplantation by intracoronary infusion in patients with acute myocardial infarction

目的研究自体骨髓单个核细胞梗死相关冠脉内移植治疗急性心肌梗死的临床疗效与安全性。方法入选32例NYHA心功能分级Ⅱ～Ⅲ级行择期PCI术的AMI患者,年龄32～77(48.8±15.2)岁,心肌梗死病史时间小于4周,女性11例,男性21例。随机分为对照组(PCI+NS)与试验组(PCI+BM-MNCs)。对照组与试验组在PCI术结束后分别通过大腔导管于梗塞相关血管注入NS与BM-MNCs。对所有患者于PCI术前,术后45d、90d行ECG、24h动态心电图、静息Te99mSPECT检查。结果①试验组用Ficoll密度梯度离心法获得单个核细胞1.6×108～5.8×108[(3.5±1.8)×108]个,细胞活性均大于92%。②试验组与对照组术后45d静息Te99mSPECT灌注缺损区面积较术前分别缩小34.32%和23.05%(P<0.05),且两组组内比较差异有统计学意义(P<0.05);试验组与对照组术后90d静息Te99mSPECT灌注缺损区面积较术后45d分别缩小14.77%和3.82%(P<0.05),但两组组内比较仅试验组差异有统计学意义(P<0.05)。③24hHolter监测,室性心律失常及心动过缓在术前,术后45d、90d同期两组间比较差异无统计学意义(P>0.05)。结论自体骨髓单个核细胞梗死相关冠脉内移植治疗急性心肌梗死有一定的疗效,并且不增加心律失常的发生率。

Objective To assess the efficacy and safety of autologous bone marrow mononuclear cells transplantation by intracoronary infusion in patients with AMI. Methods We studied 32 patients who underwent percutaneous coronary intervention （PCI） after AMI with NYHA Ⅱ - Ⅲ class. Thirty-two patients （21 males and 1 lfemales）,who had AMI within previous four weeks, were divided into trial group and control group randomly. Normal saline or autologous bone marrow mononuclear cells （BM-MNCs） was infused into the infarct related artery （IRA） through the guiding catheter after PCI in control group and trial group respectively. ECG, Hoher, SPECT were assessed before PCI ,45d, 90d after that. Results （1） BM-MNCs was cultured and harvested by the method of Ficoll. 1.6×10^8-5.8×10^8 （3.5±1.8×10^8） BM-MNCs were obtained and more than 92% cells were alive. （2）SPECT scan.Results showed that perfusion defect decreased 34.32% and 23.05% than base-line at 45d in trial and control group respectively （P〈0.05）.The perfusion defect decreased 14.77% and 3.82% at 90d than 45d in trial and control group respectively （P〈0.05）. （3）24 h electrocardiographic monitoring demonstrated that there was no difference in the occurrence of ventriarrhythmia or bradycardia before PCI, 45 and 90 d after that （P〉0.05）.Conclusions BM-MNCs transplantation by intracoronary infusion have some efficacy in patients with AMI and malignant arrhythmias is not increased.