参芪络通胶囊治疗糖尿病下肢血管病变临床研究

Clinical Observation of Shenqiluotong Capsule on 100 Patients with Diabetes Mellitus Crura Angiopathy

目的观察参芪络通胶囊治疗糖尿病下肢血管病变的临床疗效。方法将200例糖尿病下肢血管病变患者随机分为2组。治疗组100例,采用参芪络通胶囊加肠溶阿司匹林片口服;对照组100例,单用肠溶阿司匹林片口服。连续用药3个月,观察2组综合疗效,治疗前后临床症状和体征、血糖、血脂、血液流变学变化及不良反应情况。结果治疗组总有效率89%,对照组总有效率71%,2组比较差异有统计学意义(P<0.05)。2组治疗后空腹血糖(FBG)、餐后2h血糖(PBG)、糖化血红蛋白(HbA1c)、低密度脂蛋白胆固醇(LDL-C)均较治疗前降低(P<0.05);治疗组三酰甘油(TG)、总胆固醇(TC)较治疗前降低(P<0.05),2组治疗后TC、HbA1c、LDL-C比较差异有统计学意义(P<0.05)。治疗组全血粘度、红细胞聚集指数和纤维蛋白原治疗后均较对照组明显降低(P<0.05)。彩色多普勒示治疗组血流动力学指标较治疗前明显改善,下肢动脉的内径增宽、峰值流速下降及血流量增多。结论参芪络通胶囊治疗糖尿病下肢血管病变疗效确切,无明显不良反应。

Objective To observe the clinical effect of Shenqiluotong capsule on diabetes mellitus crura angiopathy. Methods Two hundred patients with diabetes mellitus crura angiopathy were randomly divided into two groups. One hundred patients in the treatment group were administrated Shenqiluotong capsule and enteric- coated aspirin tablet orally. One hundred patients in the control group were only given enteric-coated aspirin tablet orally. The effectiveness, clinical symptom and sign, glucose, blood fat, hemodynamics, crura artery diameter, peak value rate, blood flow volume and side effect were observed before and after treatment. Results The total effective rate in the treatment group and the control group were 89 % and 71% respectively （P〈0.05）. The level of FBG, PBG, HbA1c, TG, TC and LDL significantly decreased in both groups after treatment compared with those before treatment （P 〈0.05）. There was a significant difference of TC and TG after treatment between the two groups （P〈0.05）. The level of blood viscosity, red blood cell aggregation index and fibrinogen in the treatment group significantly decreased after treatment compared with that in the control group （P〈0.05）. Doppler showed that the hemodynamic indexes in the treatment group were significant improved after treatment. The diameters of the vessels were widened, the peak flow velocity lowered, blood flow volume increased. Conclusion Shenqiluotong capsule is effective in the treatment of diabetic crura angiopathy, without obvious side effects.