茵栀汤治疗糖尿病足临床研究  

Clinical trials of Yinzhi Tang in Treatment of Diabetic Foot.

作　　者：张东萍[1] 杨博华[1] 秦建辉[1] 陈蕾[1] 刘凤桐[1] 路红[1] 李友山[1] 林冬阳[1] 

机构地区：[1]北京中医药大学东直门医院血管外科,100700

出　　处：《医学研究杂志》2006年第9期59-61,共3页Journal of Medical Research

基　　金：北京中医药大学吕亚芳科研基金资助项目

摘　　要：目的 糖尿病足感染的主要病因湿热。清热利湿法是治疗糖尿病足急性期有效方法。为了比较清热利湿方茵栀汤和抗生素的疗效，我们研究了糖尿病足溃疡病人不同治疗药物作用的差别。方法 利用前瞻随机区组分层将糖尿病足感染病人均等分配到各组，分别治疗10～14天。结果 34例应用茵栀汤治疗，28例用对照药物治疗。两组在临床有效率、溃疡愈合状况、血糖指标上无显著差异。茵栀汤在改善糖尿病足患者踝／肱指数方面优于抗生素。治疗期间均有良好的耐受。结论 在治疗糖尿病足感染方面茵栀汤与通常应用的对照组抗生索疗效相近，在改善踝／肱指数方面优于抗生索。治疗这类感染尤其是湿热壅盛证的病人，清热利湿是有效的治疗方法。Objective The predominant pathogens causing diabetic foot infections are dampness - heat in TCM. Clearing heat and removing dampness is a method that is active against most diabetic foot in acute stage. To compare the effectiveness of the clearing heat and removing dampness prescription Yinzhi Tang against semi - synthetic penicillins, vancomycin or tobramycin, we analysed the subset of diabetic patients with an infected ulcer enrolled in two randomized, controlled trials of patients with complicated skin and soft - tissue infections. Methods Patients with a diabetic ulcer infection were prospectively stratified to ensure they were equally represented in the treatment groups, then randomized to either Yinzhi Tang or a pre - selected comparator （ vancomycin, a semi - synthetic penicillin or a tobramycin） for 7 - 14 days. Results Among 62 patients with a diabetic ulcer infection, all were clinically evaluable; 34 received the Yinzhi Tang and 28 received a comparator. Success rates for patients treated with the clearing heat and removing dampness prescription or the comparators were not statistically different for clinical （85% versus 79% , respectively; 95% CI） or curing of the ulcer and blood sugar index outcomes. The amelioration of Acroanesthesia, pain, skin temperature, A/B index was achieved in the treatment group compared to the control group. The effect of improving the pulse of dorsal artery of foot of both group is not certain. Both treatments were generally well tolerated, with most adverse events of mild to moderate severity. Conclusions The clinical efficacy and safety of the prescription Yinzhi Tang was similar to those of commonly used comparator antibiotics for treating infected diabetic foot ulcers. It is superior to antibiotics in ameliorating clinical symptoms. The clearing heat and removing dampness prescription should be considered for treating these infections, especially those caused by dampness -heat pathogen.

关 键 词：清热利湿法 糖尿病足 随机对照 临床研究 

分 类 号：R473.5[医药卫生—护理学]