Abstract:Objective To investigate the clinical efficacy of berberine combined with cilostazol in the treatment of lower extremity arteriosclerosis obliterans (ASO) and to explore its possible mechanism.Methods A prospective randomized controlled study was conducted.A total of 30 patients with lower extremities ASO in intermittent claudication stage diagnosed at Jiangsu Province Hospital of Chinese Medicine from May 2015 to May 2017 were selected and randomly divided into treatment group and control group ( n=15,each).The control group was treated with cilostazol(0.3 g/time,3 times/d),while the treatment group was treated with berberine(100 mg/time,3 times/d) on the basis of the control group.The clinical efficacy was observed.Blood routine test,liver and kidney function,the number of endothelial progenitor cells (EPCs) and the levels of stromal cell-derived factor-1α (SDF-1α),vascular endothelial growth factor (VEGF),endothelial nitric oxide synthase (eNOS) and nitric oxide (NO) levels were detected before and after treatment.Results After 8 weeks of treatment,there was no significant difference in blood routine,liver and kidney function,blood lipid and blood glucose between the two groups before and after treatment ( P>0.05).Systolic blood pressure in the treatment group was significantly lower than that before treatment ［(132.10±8.78) mm Hg vs (136.50±9.31) mm Hg, t=2.377, P=0.041］.The right ankle/brachial index (ABI) significartly increased in both groups ( P<0.05),but the left ABI level was significantly improved only in the treatment group (0.73±0.13 vs 0.69±0.15, t=4.075, P=0.003).After treatment,the intermittent claudication distance of the two groups were increased ( P<0.05),while the increase value of intermittent claudication distance in the treatment group was higher ［(307.70±119.40) m vs (181.80±29.20) m, t=3.471, P=0.001］.After treatment,the number of EPCs in the treatment group increased significantly (0.044±0.007 vs 0.018±0.004, t=12.490, P<0.01),but there was no significant difference in the control group ( P>0.05).After treatment,the levels of SDF-1α,eNOS and NO in the two groups increased ( P<0.05, P<0.01),and the levels of each factor in the treatment group were higher than those in the control group ( P<0.05).There was no significant difference in VEGF level between the two groups before and after treatment ( P>0.05).Conclusions Berberine combined with cilostazol is safe and effective in the treatment of lower extremity ASO.It may affect the production of eNOS and NO through SDF-1α pathway,and further lead to the increase of EPCs and functional changes.