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目的比较不同来源和移植途径的自体干细胞治疗糖尿病缺血性下肢血管病变的临床疗效。方法 2010年8月至2012年3月,根据纳入和排除标准,选择76例糖尿病缺血性下肢血管疾病患者,随机分为四组,自体外周血干细胞(PBSC)局部肌肉注射移植组(PBSC-MI组)、PBSC动脉腔内注射移植组(PBSC-AI组)、自体骨髓干细胞(BMSC)局部肌肉注射移植组(BMSC-MI组)、BMSC动脉腔内注射移植组(BMSC-AI组),每组患者均为19例,基线资料匹配。评估移植后第2,4,12,24,48周临床症状主观指标和仪器检查客观指标数据变化。结果 (1)与0周相比,四组患者中反映缺血状况的主观指标(疼痛评分、冷感评分、麻木评分)以及客观指标包括皮肤温度、踝肱指数(ABI)、经皮氧分压(TcPO2)、间歇性跛行距离、下肢动脉的CTA评分,分别在接受干细胞移植治疗4周和12周后开始显著改善,至24周最佳(P<0.05)。(2)四组间分别在不同随访时间的疼痛评分、冷感评分、麻木评分、皮肤温度、ABI、TcPO2、间歇性跛行距离、下肢动脉的CTA评分均无显著差异(P>0.05)。结论不同来源和移植途径的自体干细胞治疗糖尿病缺血性下肢血管病变疗效相当。
Objective To compare the clinical efficacy of autologous stem cells from different sources and transplantation in the treatment of diabetic ischemic lower extremity vascular disease. Methods From August 2010 to March 2012, 76 patients with diabetic ischemic lower extremity vascular disease were selected according to inclusion and exclusion criteria, and were randomly divided into four groups: PBSC-intramuscular injection group (PBSC- MI group), PBSC-AI group, BMSC-MI group, BMSC-B group, BMSC-AI group, Each group of patients were 19 cases, the baseline matching data. The subjective indexes of clinical symptoms and the changes of objective indexes of instruments during the2th, 12th, 24th and48th weeks after transplantation were evaluated. Results (1) Compared with 0 week, the subjective indexes (pain score, cold sensation score, numbness score) reflecting the ischemic status in four groups of patients and the objective indexes included skin temperature, ankle brachial index (ABI) TcPO2, intermittent claudication and CTA scores of lower extremity arteries began to improve significantly at 4 and 12 weeks after stem cell transplantation, respectively, and were best at 24 weeks (P <0.05). (2) There was no significant difference in pain score, cold sensation score, numbness score, skin temperature, ABI, TcPO2, intermittent claudication distance and CTA score of lower extremity artery at different follow-up time among the four groups (P> 0.05). Conclusion Autologous stem cells from different origins and transplantation pathways are effective in treating diabetic ischemic lower extremity vascular disease.