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目的本研究对比观察一组治疗上除心脏移植外,不能或难于从其他任何治疗中获益的重度缺血性心力衰竭(end-stage ischemia heart failure,EIHF)患者,给予经冠状动脉自体骨髓单个核细胞(bone marrow mononuclear cells,BM-MNCs)移植,探索其治疗的可行性、安全性及不良反应。方法30例EIHF患者入选。分为:细胞移植组(n=16)和常规治疗组(n=14)。细胞移植组和常规治疗组治疗前、后随访观察临床表现、实验室检查、二维超声心动图、正电子断层心肌显像(PET)、Holter、血管活性肽等。梯度密度法分离自体BM-MNCs。细胞移植组:经冠状动脉选择性细胞移植,平均BM-MNCs(5．0±0．7)×107。常规治疗组:除细胞移植外其他治疗均同细胞移植组。结果16例细胞移植手术均安全。2例于细胞注入后15-30 min感全身发冷,30 min后好转。1例细胞注入时出现短暂自限性室性早搏。术后48 h持续心电监测未出现新的心律失常。细胞移植组:术后观察半年患者均未再发急性肺水肿,心力衰竭症状明显改善。3个月NYHA分级明显改善[(3．4±0．1)级→(2．4±0．2)级,P<0．001];左心室射血分数(LVEF)于术后7天、3个月分别较术前增加9．6％(P<0．05)、9．9％(P<0．001);:PET显示代谢活力心肌增加(10．3±3．4)％(P<0．01)。血浆脑型利钠肽(brain-type natriuretic peptide,BNP)显著降低,3天、7天分别较术前下降69．2％(P<0．05)、70．4％(P<0．05);心房利钠肽(atrial natriuretic peptide,ANP)增加,术后第7天为术前1．3倍(P< 0．05);6个月随访无一例死亡,仅1例心力衰竭加重住院。而对照组3个月心功能检测明显恶化; NYHA分级下降[(3．5±0．1)级→(3．9±0．1)级,P<0．05];LVEF较术前减低7．2％(P<0．001),与细胞移植组相比差异有显著统计学意义(P<0．001);6个月随访死亡2例;因心力衰竭恶化再住院率71．4％(10／14)。结论自体BM-MNCs经冠状动脉移植治疗EIHF患者是安全有效的,显著改善了近期预后。
Aims This study compared a group of patients with severe end-stage ischemia heart failure (EIHF) who were not treated with heart transplantation and were otherwise refractory to any other treatment and were given a single autologous bone marrow Bone marrow mononuclear cells (BM-MNCs) transplantation to explore the feasibility of its treatment, safety and adverse reactions. Methods Thirty patients with EIHF were enrolled. Divided into: cell transplantation group (n = 16) and the conventional treatment group (n = 14). The clinical manifestations, laboratory tests, two-dimensional echocardiography, positron emission tomography (PET), Holter, vasoactive peptide and so on were observed before and after treatment in the cell transplantation group and the conventional treatment group. Gradient separation was performed on BM-MNCs. Cell transplantation group: Coronary artery selective cell transplantation, the average BM-MNCs (5.0 ± 0.7) × 107. Conventional treatment group: except for cell transplantation, other treatments were the same as cell transplantation group. Results 16 cases of cell transplantation were safe. In 2 cases, the whole body was chilled 15-30 minutes after the cells were infused and improved after 30 minutes. A case of short-term self-limiting ventricular premature beats when injected. 48 h after the continuous ECG did not appear new arrhythmia. Cell transplantation group: Six months after operation, no acute pulmonary edema was observed and symptoms of heart failure were significantly improved. After 3 months, the NYHA classification improved significantly ([3.4 ± 0.1] → (2.4 ± 0.2), P <0.001]; left ventricular ejection fraction (LVEF) (P <0.05), 9.9% (P <0.001) at 3 months respectively ;: PET increased the myocardial viability by 10.3 ± 3.4% (P <0.01). Plasma BNP decreased significantly (P <0.05) and decreased to 70.4% (P <0.05) on the 3rd day and the 7th day compared with that before the operation ); Atrial natriuretic peptide (ANP) increased in the first 7 days after operation, 1.3-fold (P <0.05) preoperatively; none died within 6 months of follow-up; only 1 patient with HF worsens . While the control group 3 months cardiac function was significantly worsened; NYHA classification decreased [(3.5 ± 0.1) grade → (3.9 ± 0.1) grade, P <0.05]; LVEF decreased compared with preoperative (P <0.001). The difference was statistically significant (P <0.001) compared with the cell transplantation group (P <0.001). Two patients died after 6 months of follow-up. The hospitalization rate was 71.4 % (10/14). Conclusion Autologous BM-MNCs are safe and effective in the treatment of patients with EIHF by coronary artery transplantation, and significantly improve the short-term prognosis.