Efficacy Of Bone Marrow Mononuclear Cells In The Treatment Of Peripheral Arterial Diseases Except Diabetic Foot Disease With Failed Revascularization:A Meta-analysis

OBJECTIVE: Peripheral arteriosclerotic disease(PAD)is a common disease in which atherosclerosis involves one or more lower extremity vessels.Severe limb ischemia(CLI)is the most advanced stage of peripheral arterial disease?The data of the amputation rate and mortality rate in patients with PAD were 21.5% and 13.5%,and the 1-year amputation rate and mortality rate of CLI patients were as high as 30% and 25%[28].In 2002,Japanese scholar Tateishi-Yuyama and others first reported the therapeutic angiogenesis test(TACT)[1] using cell transplantation,and the clinical safety and efficacy of stem cell therapy were initially confirmed.Although related clinical research has been reported for more than ten years,stem cell therapy is still in the research stage before clinical large-scale,conventional therapeutic applications.In this study,a meta-analysis of the efficacy of bone marrow mononuclear cells in the treatment of peripheral arterial disease except diabetic foot disease with failed revascularization was performed.The differences in the efficacy of 12 W and 24 W after stem cell injection were investigated.The difference in the efficacy of multiple injections of stem cells versus single injection of stem cells.The difference in efficacy between the bone marrow stem cell injection group and the control group.Method: We finally included articles published in PubMed,The Medline,EMBASE,Google Scholar,The databases database,Wanfang,Weipu,CNKI China Knowledge Network database all related articles,from the construction of the database to December 01,2018.We received a total of 612 articles.Meta-analysis of all data was performed using StataSE 12.0 software.RESULTS: Strictly collected and screened according to inclusion and exclusion criteria,a total of 6 articles(5 randomized controlled trials,1 prospective study)were included,including a total of 348 patients,of whom 196 received bone marrow stem cell therapy,152 patients received a control treatment.The results showed that the beneficial effects of the post-treatment efficacy indicators in the bone marrow stem cell group were as follows:(1)When the 12 w was observed,the sputum index(ABI)was increased(WMD=0.170;95% CI,0.152-0.189,P<0.05).Pain score(VAS)decreased(WMD=-3.334;95% CI,-4.765--1.923,P <0.05);(2)Observed index(ABI)increased at 24w(WMD = 0.171;95% CI,0.118-0.223,P<0.05),pain score(VAS)decreased(WMD=-3.666;95% CI,-5.22-2.100,P<0.05),painless walking distance(PFWD)Increased(WMD=129.127;95% CI,68.600-189.655,P<0.05),ulcer area decreased(WMD=-2.945;95% CI,-4.910--0.981,P<0.05);(3)24w vs.12 w,there was a small increase in sputum index(ABI)(WMD=0.022;95% CI,0.002-0.042,P<0.05),and a small reduction in pain score(VAS)(WMD=-0.815;95% CI,-0.969--0.662,P<0.05);(4)multiple stem cell injection vs.single stem cell injection: ankle index(ABI)increased(WMD = 0.087;95% CI,0.057-0.117,P < 0.05),The pain score(VAS)was significantly reduced(WMD=-0.321;95% CI,-0.587--0.055,P<0.05),and the ulcer area was significantly reduced(WMD=-3.140;95% CI,-3.886--2.413,P <0.05),the number of large amputations is not significantDifferences(RR=1.037;95% CI,0.654-1.645,P>0.05);(5)observation of the 24 w bone marrow stem cell treatment group versus placebo control group: pain score(VAS)decreased(WMD=-1.685;95 % CI,-1.770-1.401,P < 0.05),there was no significant difference in the number of large amputations(WMD = 1.175;95% CI,0.392-3.520,P > 0.05);(6)observation of the 24 w bone marrow stem cell treatment group Compared with the peripheral blood cell control group: the sputum index(ABI)increased(WMD = 0.087;95% CI,0.070-0.105,P < 0.05),and the pain score(VAS)decreased(WMD =-0.996;95% CI,-1.707--0.186,P<0.05),no painful walking distance(PFWD),no significant difference(WMD=36.411;95% CI,-19.440-92.263),P>0.05),ulcer area healing was not significant There were no significant differences in the number of large amputations(WMD = 1.008;95% CI,0.607-1.676,P>0.05).Conclusion: According to the results,it is concluded that the use of bone marrow mononuclear cells to treat peripheral arterial disease except diabetic foot disease with failed revascularization is effective,and multiple injections of stem cells are more effective.