冠状动脉旁路移植术同期自体骨髓干细胞移植治疗晚期缺血性心脏病临床研究的早期结果

Early Clinical Trial Study for Intraoperative Autologous Bone Marrow Transplantation in Ischemia-Induced Congestive Heart Failure

目的:评价自体骨髓单个核细胞移植对晚期冠心病陈旧性心肌梗死患者心功能改善的早期影响。方法:前瞻性设计入组需要外科治疗的晚期冠心病陈旧性心肌梗死患者20例。在冠状动脉旁路移植手术同期,采用随机双盲,平行对照的方法经冠状动脉桥血管移植自体骨髓单个核细胞,患者随机分为干细胞治疗组与对照组。应用磁共振成像评价治疗前后心功能的变化,同时评价不良事件的发生。结果:试验揭盲后干细胞治疗组9例,对照组11例。手术早期结果无死亡。随访6个月,患者均存活,随访期间无不良事件发生。磁共振成像检查,手术后2组患者左心室射血分数较术前明显提高,差异有统计学意义(P=0.006),而两组间差异无统计学意义。手术后节段左心室壁增厚率干细胞治疗组大于对照组(P=0.044)。结论:冠状动脉旁路移植术同期自体骨髓单个核细胞经桥血管心肌内移植是安全的,治疗早期无不良反应。早期结果显示:节段左心室壁增厚率的变化干细胞治疗组优于对照组。

Objective：To evaluate the safety and efficacy of autologous bone marrow mononuclear cells （MNCs） transplantation during coronary artery bypass grafting（CABG） in the treatment of ischemia-induced congestive heart failure. Methods：A total of 20 consecutive patients with the average left ventricular ejection fraction（LVEF） of 25.64 ± 5.65% from 2006 to 2008 in our hospital were enrolled in this trial. MNCs were harvested before chest opening from 9 patients and 132. 1 ± 169. 8 millions of cells were infused through bypass graft during the on-pump CABG to thosc patients respectively as Treatment group. Another 11 patients served as Control group, the same volume of saline was infused. Magnetic resonance imaging（MRI） was performed to evaluate prei-and post-operative heart function, segment vertical wall motion and thickness. All patients were followed up for 6 months and major adverse cardiovascular events （MACE） were recorded. Results ：There were no MACE occurred during the follow up period of time. MRI result indicated that LVEF increased in both groups after the operation （ P = 0. 006 ）, while there was no significant difference between two groups. Compared with Control group,left ventricular quality and segmental ventricular wall thickness were obviously improved in Treatment group （P=0. 044）. Conclusion：Intraoperaive autologous MNCs transplantation was feasible and safe in selected ischemia-induced heart failure patients. It improved the segment ventricular wall thickening rate during this early clinical trail study.