摘要:Objective To compare the effectiveness of autologous stem cells implantation among different sources and ways of transplanting in a randomized controlled trial for the treatment of diabetic lower limb ischaemia. Methods From August 2010 to April 2012, according to the inclusion and exclusion criteria, 76 diabetic patients with lower limb ischemia were randomised into four groups, of which baseline data were matched, included treated with autologous peripheral blood stem cell(PBSC)implantation by local intramuscular injection (group PBSC-MI, n=19), with PBSC implantation by intra arterial injection (group PBSC-AI, n=19), with autologous bone marrow stem cell(BMSC)implantation by local intramuscular injection ( group BMSC-MI, n=19), with BMSC implantation by intra arterial injection(group BMSC-AI, n=19). A series of subjective indexes and objective indexes were valued after autologous stem cells implantation at 2,4,12,24,48 weeks, respectively. Results (1)Compared with 0 week, a series of subjective indexes(such as pain score, cold sensation score and numbness score) and objective indexes such as skin temprature, ankle brachial index(ABI), transcutaneous oxygen pressure(TcPO2), intermittent claudication distance and lower extremity arterial CTA score, were significantly improved at 4 weeks and 12 weeks, respectively, and the best effectiveness were observed at 24 weeks after autologous stem cells implantation(P<0.05). (2)Pain score, cold sensation score and numbness score, skin temprature, ABI, TcPO2, intermittent claudication distance and lower extremity arterial CTA score had no significant difference among four groups at different follow-up time, respectively(P>0.05). Conclusion The effectiveness of autologous stem cells implantation among different sources and ways of transplanting were equivalent in the treatment of diabetic lower limb ischaemia.%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。