不同移植浓度自体骨髓干细胞治疗下肢缺血临床疗效的影响

目的比较自体骨髓干细胞不同移植浓度的临床疗效,探讨其在治疗下肢缺血的临床作用和近期疗效。方法2003年12月~2004年12月,对22例双下肢缺血的患者行自体骨髓干细胞移植治疗。将每一患者其中缺血较严重的一侧分为实验组(A组),较轻的一侧为对照组(B组)。A组移植骨髓干细胞浓度>1×108个/条下肢,B组<1×105个/条下肢。应用谷涌泉提出的患肢疼痛、冷感和麻木等主观标准,间歇性跛行距离、踝肱指数(ankle/brachialindex,ABI)、经皮氧分压(transcutaneousoxygenpressure,TcPO2)、Tateishi-Yuyama等提出的新生侧支血管评估、保肢率和足部创面的变化等客观标准评价其疗效。术后1、2和4周分别观察其疗效,并选择4周时的疗效作为评价标准。结果A、B组疼痛缓解有效率分别为90.0%和16.7%(P<0.01),冷感缓解改善率分别为90.5%和5.3%(P<0.01),患肢麻木改善有效率分别为62.5%和9.1%(P<0.01)。术后4周的ABI测定,A、B组分别增加了31.8%和0;TcPO2测定,A、B组增加有效率分别为94.4%和11.1%(P<0.01);新生侧支血管评估分级,12例患者经术后血管造影复查,A组有效率为100%,B组除2条下肢为+1级外,余均未见增多的新生血管;截肢率A、B组分别为4.5%和27.3%(P<0.05);足部创面的变化,A组有效率为75%,B组无效。结论自体骨髓干细胞移植治疗下肢缺血性疾病的疗效与移植的干细胞总量有密切的关系,移植量<1×105个/条下肢时无效或仅有微弱疗效,移植量>1×108个/条下肢时,大多数患者是有效的,但远期疗效需进一步观察。

EFFECTIVE AUTOLOGOUS BONE MARROW STEM CELL DOSAGE FOR TREATMENT OF SEVERE LOWER LIMB ISCHEMIA

OBJECTIVE :To explore the effective autologous bone marrow stem cell dosage for treatment of severe lower limb ischemia. METHODS: From December 2003 to December 2004, 22 cases of bilateral lower limb ischemia were treated with autologous bone morrow cell transplantation. All the patients were randomly divided into two groups according to ischemia degree. In group A (severe ischemia side), the amount of transplanted autologous bone marrow cells was more than 1 X 10(8), and in group B (mild ischemia side), the amount was less than 1 X 10(5). A series of subjective indexes, such as improvement of pain, cold sensation and numbness, and objective indexes, such as increase of ankle/brachial index (ABI) and transcutaneous oxygen pressure (TcPO2), angiography, amputation rate, and improvement of foot wound healing were used to evaluate the effect of autologous bone marrow stem cells implantation. RESULTS: The rates of pain relief were 90.0% in group A and 16.7% in group B (P<0.01); the rates of cold sensation relief were 90. 5% in group A and 5.3% in group B (P<0.01); the improvement of numbness was 62.5% in group A and 9. 1% in group B (P<0. 01). Increase of ABI was 31.8% and 0 in groups A and B respectively (P<0.01) at 4 weeks after implantation. Increase of TcPO2 was 94.4% and 11.1% in groups A and B respectively (P<0.01) at 4 weeks after implantation. Twelve cases of angiography showed rich new collateral vessels in 100% of the limbs in group A while no remarkable new collateral vessel in group B. The amputation rates were 4.5% in group A and 27.3% in group B (P<0.05) at 4 weeks after implantation. The rate of improvement of foot wound healing was 75% in group A and there was no change in wound healing in group B after 4 weeks of implantation. CONCLUSION: The effectiveness of autologous bone marrow stem cell implantation depends on the number of implanted stem cells. Effectiveness is expected in most patients if the implanted stem cell is more than 1 X 10(8), whereas there would be little effect if the cell number is less than 1 X 10(5).