Objective To observe the effect of Tangbi Washout Formula in the treatment of peripheral vascular disease in patients with type 2 diabetes mellitus.Methods Sixty patients with diabetic peripheral vascular disease treated in the Diabetes Specialist Outpatient and Ward of Guangdong Hospital of Traditional Chinese Medicine from June 2016 to June 2017 were selected as the research objects.According to a randomized,double-blind and controlled study protocol and the random number table method,they were divided into two groups.30 cases in the treatment group were treated with basic treatment plus Tangbi Washout Formula for footbath,and 30 cases in the control group were treated with routine treatment plus placebo Chinese medicine for footbath.Among which,the basic treatment included regular hypoglycemic,antihypertensive,lipid-lowering and diet exercise therapy.All patients were followed up for 12 weeks.The TCM symptom score,quality of life scale and the levels of interleukin-6 (IL-6) and serum high-sensitivity C-reactive protein (hs-CRP) in the two groups were observed and compared before and after treatment.The experimental data was analyzed by SPSS 19.0.Results After treatment,the scores of TCM syndrome in two groups were lower than those before treatment (P ＜ 0.05),and the scores of quality of life were higher than those before treatment (P ＜ 0.05).After treatment,the score of TCM syndrome in the treatment group was lower than that of the control group (P ＜ 0.05),and the score of quality of life of the treatment group was higher than that of the control group (P ＜ 0.05).The total effective rate of the treatment group was significantly higher than that of the control group (P ＜ 0.05).After treatment,the levels of hs-CRP and IL-6 in the treatment group were lower than those before treatment,which were also lower than those of control group,the differences were statistically significant (P ＜ 0.05).Conclusion Tangbi Washout Formula can effectively improve the clinical symptoms of numbness,pain,paresthesia,intermittent claudication and the quality of life in patients with diabetic peripheral vascular disease,and decrease the levels of inflammatory factors IL-6 and hs-CRP.%目的 观察糖痹外洗方治疗2型糖尿病周围血管病变的效果.方法 选择广东省中医院2016年6月～2017年6月糖尿病专科门诊及病房的糖尿病周围血管病变患者60例为研究对象,采用随机、双盲、对照的研究方案,按随机数字表法分为两组.30例治疗组接受基础治疗+袋泡糖痹外洗方沐足,30例对照组接受基础治疗+安慰剂中药沐足,其中基础治疗包括常规降糖、降压、降脂以及饮食运动治疗.随访观察12周.观察比较用药前后两组患者中医证候积分、生活质量量表评分以及白介素-6(IL-6)、超敏C-反应蛋白(hs-CRP)水平的变化情况.所得实验数据采用统计学软件SPSS 19.0作处理分析.结果 治疗后两组中医证候积分均较治疗前显著降低(P＜0.05),生活质量量表评分均较治疗前显著升高(P＜0.05),且治疗后治疗组中医证候积分明显低于对照组(P＜0.05),生活质量量表评分明显高于对照组(P＜0.05).中医疗效方面,治疗组总有效率明显高于对照组(P＜0.05).治疗组治疗后血清hs-CRP、IL-6水平较治疗前显著降低,且明显低于对照组,差异有统计学意义(P＜0.05).结论 糖痹外洗方能有效改善糖尿病周围血管病变患者下肢麻木、疼痛、感觉异常、间歇性跛行等临床症状,提高患者生活质量,降低炎症因子IL-6、hs-CRP水平.
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