复方黄柏液局部应用对糖尿病足溃疡愈合的临床研究

Topical application of compound cortex phellodendri fluid in the treatment of diabetic foot ulcer

目的:探讨复方黄柏液治疗糖尿病足溃疡的临床疗效。方法:选择2015年1月至2015年11月在天津医科大学代谢病医院糖尿病足科确诊的糖尿病足溃疡住院患者204例,随机分为试验组(100例)和对照组(104例),均采用标准化创面处理。试验组在此基础上局部应用复方黄柏液冲洗及浸润,对照组用生理盐水冲洗,保持创面湿润。治疗8周后,对2组患者溃疡面积、临床总有效率及不良事件进行统计学分析。计量资料的比较采用t检验(正态分布,用x±s表示)或Wilcoxon秩和检验[非正态分布,M(Q1,Q3)表示],计数资料采用卡方检验[用n(%)表示],采用logistic回归分析影响糖尿病足溃疡愈合的因素。结果:共有199例患者完成研究(试验组97例,对照组102例)。治疗后溃疡面积[试验组0.24(0,1.04)vs.对照组2.51(0,4.11)cm2,P=0.000]、临床总有效率(试验组92.8%vs.对照组78.4%,P=0.019)试验组均优于对照组,差异有统计学意义。治疗期间不良事件发生率(试验组26.8%vs.对照组27.5%,P=0.670)无统计学差异。红细胞沉降率(OR=0.742,P=0.032),C反应蛋白(OR=0.561,P=0.000)是影响溃疡愈合的独立危险因素,经皮氧分压(OR=8.429,P=0.001)和复方黄柏液(OR=4.500,P=0.000)是促进溃疡愈合的独立保护因素。结论:复方黄柏液对糖尿病足溃疡愈合有明显疗效。复方黄柏液通过抗感染和改善微循环促进溃疡愈合。

Objectire：To investigate the clinical efficacy of compound cortex phellodendri fluid in the treatment of diabetic foot ulcer. Methods ：Totally 204 patients with diabetic ulcer were randomly divided into test group（n=100） and control group（n=104） from Jan- uary to November 2015. The baseline level of the two groups had no difference. They both were given standard ulcer treatments. The test group applied local compound cortex phellodendri fluid flushing and infiltration,while the control group applied normal saline. After 8 weeks of treatment,the ulcer area,clinical total effective rate and adverse events of two groups were statistically analyzed. Then the factors affecting wound healing were analyzed. Results ：A total of 199 patients completed the study（97 patients in the test group,102 cases in the control group）. After treatment,the ulcer area[test group 0.24 （0, 1.04） cm^2 vs. control group 2.51 （0,4.11） cm^2,P=0.000] and clinical total effective rate（test group 92.8% vs. control group 78.4% ,P=0.019）,both in the test group were better than those in the control group, the difference was statistically significant. The incidence of adverse events in the two groups had no significant difference（test group 26.8% vs. control group 27：5% ,P=0.670）. Erythrocyte sedimentation rate （OR=0.742,P=0.032）, C-reactive protein （OR=0.561, P=0.000） were independent risk factors for affecting ulcer healing and transcutaneous oxygen pres- sure （OR=8.429, P=0.001 ） and compound cortex phellodendfi fluid （OR=4.500, P=0.000） were independent protective factor for pro-moting ulcer healing. Conclusion：Compound cortex phelloden- dri fluid has obvious effect on ulcer healing in diabetic foot ulcer. Compound cortex phellodendri fluid promotes ulcer healing by anti infection and improving mieroeireulation.