Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine, Chuo-Ku, Chiba, Japan.
Circ Cardiovasc Interv. 2009 Jun;2(3):245-54. doi: 10.1161/CIRCINTERVENTIONS.108.799361. Epub 2009 Mar 30.
Injection of bone marrow mononuclear cells has been reported to promote neovascularization of ischemic tissues effectively. We found that peripheral blood mononuclear cells were as efficient as bone marrow mononuclear cells for the treatment of limb ischemia in animals and showed that this treatment was feasible and safe in no-option patients with limb ischemia. However, the long-term outcome of such therapy has not been investigated.
We retrospectively analyzed the data for 42 patients who were treated between July 2002 and December 2005 by using the log-rank test, the Kaplan-Meier method, and the Cox proportional hazard model. Improvement of ischemic symptoms was observed in 60% to 70% of the patients. The annual rate of major amputation was decreased markedly by treatment. Improvement of ischemic symptoms was less marked in arteriosclerosis obliterans (ASO) patients on dialysis compared with nonhemodialysis ASO or thromboangiitis obliterans patients. Indeed, the survival rate of these patients was lower than that of nonhemodialysis ASO or thromboangiitis obliterans patients. Major adverse events such as death, major amputation, and cardiovascular events occurred mostly in ASO patients, and most of them were on dialysis. There was no significant difference in the cardiovascular event-free rate between responders and nonresponders. The survival rate of younger responders was better than that of nonresponders.
Although this study was not placebo-controlled and these initial results were from a retrospective analysis, injection of peripheral blood mononuclear cells might be safe and potentially effective for the treatment of limb ischemia, but caution is needed when managing ASO patients on dialysis.
骨髓单个核细胞的注射已被报道能有效地促进缺血组织的新生血管形成。我们发现外周血单个核细胞在治疗动物肢体缺血方面与骨髓单个核细胞同样有效，并表明这种治疗在肢体缺血的无选择患者中是可行和安全的。然而，这种治疗的长期效果尚未被研究。
我们使用对数秩检验、Kaplan-Meier 方法和 Cox 比例风险模型对 2002 年 7 月至 2005 年 12 月期间接受治疗的 42 例患者的数据进行了回顾性分析。60%至 70%的患者观察到缺血症状的改善。治疗后，主要截肢的年发生率显著降低。与非透析动脉硬化闭塞症（ASO）或血栓闭塞性脉管炎患者相比，透析的 ASO 患者缺血症状的改善不那么明显。事实上，这些患者的生存率低于非透析 ASO 或血栓闭塞性脉管炎患者。主要不良事件如死亡、主要截肢和心血管事件主要发生在 ASO 患者中，且大多数患者正在透析。在有反应者和无反应者之间，心血管事件无事件生存率没有显著差异。年轻有反应者的生存率优于无反应者。
尽管这项研究没有安慰剂对照，并且这些初步结果来自回顾性分析，但外周血单个核细胞的注射可能是安全的，并且对治疗肢体缺血具有潜在的有效性，但在治疗透析的 ASO 患者时需要谨慎。
