| Background:Arteriosclerotic obliterans of lower limb, diabetic foot and thromboangiitis obliterans are types of lower extremity ischemic arterial diseases which are very common in clinical practice. Although there has been some progress in traditional drug treatment and in methods of autologous blood vessel bypass operation, even pioneering application of sympathectomy to dilate small blood vessels, the curative efficacy about the distal lower extremity of poor arterial outflow still appear imprecise, which always causes a high amputation rate, ultimately affected the quality of patients' life seriously. In the end of the 20th century, 'therapeutic angiogenesis' concept was introduced into the vascular surgery field. Bone marrow mononuclear cells (MNC) and bone marrow-derived mesenchymal stem cells (MSC) autologous transplantation in the treatment of lower limb ischemic diseases has been a new strategy in recent years, because lots of studies have confirmed that MNC and MSC could perform the critical role in angiogenesis progress, but comparative studies are fairly rare not only in domestic medical field but foreign field between the curative efficacy of MSC and MNC in the treatment of the lower limb ischemic diseases, this study will focus on the different curative efficacy between MSC and MNC autologous transplantation in the treatment of the lower extremities ischemic diseases through arterial intervention using a number of measurements.Objective:To compare the curative efficacy after autologous transplantation of bone marrow mononuclear cells and bone marrow-derived mesenchymal stem cells on the lower limb ischemic disease through arterial intervention, intending to find the more effective one.Methods:From December 2003 to June 2007, according to the selected standards ofthis study, 52 patients, who were all diagnosed lower limb ischemia through theexamination of arterial , were randomly divided into two groups, namely theMNC group and the MSC group. Under local anesthesia, we took 50-100mlbone marrow blood from the patients' iliac spine, then isolated bone marrowmononuclear cells, which can be immediately autologous transplanted orcultured for 2-4 weeks to obtain bone marrow-derived mesenchymal stem cells.Before cells transplantation, cell concentration was control about 1×10~7/ml inscale and the quantity was 40ml, the autologous transfusion could be performedthrough femoral arterial or popliteal arterial intervention respectively, every case's postoperative follow-up should be more than 6 months up to one year. On the preoperative baseline and postoperative one week, two weeks, four weeks, two months, 6 months and 12 months observe point, by detecting the patients' pain score, ulcer score, claudicating distance score, at two months by observing the lower extremity perfusion namely emission-computed tomography (ECT) value, we compared the different curative efficacy between the two groups. All the collected data was used the statistical package SPSS13.0 software choosing different statistics methods such as non-parameter analysis, P value <0.05 was statistically significant for the tests.Results:1.Sex ratio, age, risk factors, disease categories, vascular occlusion level, amputation rate differences in the two groups were not statistically significant (p> 0.05), and two groups of patients' baseline information were balance.2. After autologous cell transplantation at various testing points, the two groups' differences in pain score, ulcer score, claudicating distance score changing with time were statistically significant (F = 24.434, p <0.001; F = 58.503, p <0.001; F = 23.133, p <0.001), but the differences of the scores' changing tendency with the time between the two groups were not statistically significant (F = 0.019, p = 0.891; F = 1.17, p = 0.287; F = 1.01, p = 0.32).3.Two groups' differences between pre- and post-operation considering the lower extremity dorsalis pedis/forearm ECT value and posterior tibial/forearm ECT value, were statistically significant (F = 126.166, p <0.001; F = 19.086, p <0.001), and the tests also showed that differences of the values' changing tendency between the two groups in the lower extremity dorsalis pedis/forearm ECT value and posterior tibial/forearm ECT value were statistically significant (F = 0.02, p = 0.016; F = 1.948, p = 0.027).4. All the selected patients during cells transplantation and follow-up process didn't have any transplantation related complications and adverse reactions.Conclusions:1 .The two groups of patients in the lower extremity pain, ulcer healing, lower limb motor ability are significantly improved, but the differences of above curative indicators in two groups were not significant.2.The two groups of patients' blood perfusion on the lower extremity is increased compared with the preoperative situation. The result of this study also shows that bone marrow-derived mesenchymal stem cells autologous transplantation appeared more efficient than bone marrow mononuclear cells transplantation in the treatment of lower extremity ischemic disease.3.Lower extremity arteries' ECT examination should be more sensitive than pain score,ulcer score and claudication distance score to reflect the therapeutic effect after autologous stem cells transplantation to improve ischemia situation. |
