摘要
背景:国外动物实验表明体外扩增自体骨髓间充质干细胞移植治疗糖尿病足效果较好。目的:观察自体骨髓间充质干细胞体外扩增后患肢移植的效果和安全性。设计:随机对照临床观察。对象:解放军第三军医大学西南医院2006-10/2008-10住院确诊的糖尿病足患者40例,男22例,女18例,年龄(64.3±12.7)岁,按wagner分级2级8例,3级18例,4级14例。按查表法随机分为细胞移植组22例,常规治疗组18例,实验经医院伦理委员会讨论批准。方法:常规治疗组给予常规降糖、降压、调脂、抗感染、抗凝、营养神经、扩张血管等药物治疗,局部常规换药,有坏疽者行截趾治疗;细胞移植组在常规治疗的基础上,按密度梯度离心和贴壁法分离制备骨髓间充质干细胞悬液,经流式细胞仪鉴定、染色体检测、细胞悬液皮试后,予肌肉注射法行扩增后自体骨髓间充质干细胞移植。主要观察指标:细胞移植后1个月两组患者治疗效果的比较,鉴定可能不良事件和副反应。结果:移植后1个月,细胞移植组患者肢体疼痛、冷感、间歇性跛行均有所改善,踝肱指数明显升高,双下肢血管显像血流灌注有所增加,与常规治疗组比较差异均有显著性意义(P<0.01)。移植后3个月随访患者均无异常症状体征出现,血、尿、便常规检测正常,心电图和肝肾功能无特殊改变,出凝血时间正常。结论:体外扩增自体骨髓间充质干细胞移植患肢治疗糖尿病足简便、有效、安全。
BACKGROUND： In an animal model of hindlimb ischemia, the outcome of transplantation of bone marrow mesenchymal stem cells was better than that of bone marrow mononuclear cells. OBJECTIVE： To evaluate the efficacy and safety of transplantation of autologous bone marrow mesenchymal stem cell （BMSC） following amplification in vitro for treating diabetic foot. DESIGN： Randomized controlled clinical study. PARTICIPANTS： A total of 40 diabetic foot patients were enrolled at the Southwest Hospital of Third Military Medical University of Chinese PLA from October 2006 to October 2008, comprising 22 males and 18 females, aged （64.3±12.7） years. There were 8 cases of grade 2, 18 cases of grade 3, 14 cases of grade 4 according to Wagner classify. In accordance with lookup table, they were randomized to cell transplantation group （n=22） and conventional treatment group （n=18）. The protocols were approved by Hospital＇s Ethics Committee. METHODS： In the conventional treatment group, patients were subjected to treatment of conventional glucose-control, blood pressure- control, anti-infection, anti-coagulation, nerves-nourishing, and blood vessel distension; drugs were conventionally changed in local sites; patients with gangrene received toe amputation. In the cell transplantation group, patients underwent BMSC transplantation in addition to conventional treatment. BMSC suspension was prepared by the density gradient centrifugation and adherent culture. After flow cytometry, chromosome analysis, etiology detection and cell suspension skin test, BMSC were infused into the affected leg and foot by multiple-point intramuscular injection. MAIN OUTCOME MEASURES： Therapeutic efficacy was compared between these two groups 1 month after transplantation. Adverse event and side reaction were measured. RESULTS： One month after BMSC transplantation, the symptoms of cell transplantation group were improved markedly, including severe pain, intermittent claudication, and local cool. Ankle-brachial index increased obviously. Magnetic resonance imaging of lower limb blood vessel displayed that the blood stream of lower limbs had increased, which showed significant differences compared with the conventional treatment group （P〈0.01）. During three months of follow-up, no abnormal symptoms were found, and conventional determination of blood, urine and excrement showed normal results. No special changes were detected in electrocardiogram and liver and kidney function. Clotting time was normal. CONCLUSION： Transplantation of autologous BMSCs following amplification in vitro might be a simple, safe and effective method for the treatment of diabetic foot.
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2009年第32期6227-6230,共4页
Journal of Clinical Rehabilitative Tissue Engineering Research
基金
第三军医大学西南医院临床研究专项基金A类资助课题(SWH2005A109)~~
