非严重缺血性糖尿病足中医辨证外治的多中心随机对照临床研究  

A multi-centered, randomize-controlled trial on external treatment of TCM based on syndrome differentiation for non-severe ischemic diabetic foot

作　　者：李大勇[1] 吕延伟 李鑫[1] 杨博华[2] 张朝晖[3] 甘宇[4] 王鹏[5] 

机构地区：[1]辽宁中医药大学附属医院,沈阳110032 [2]北京中医药大学东直门医院,北京100700 [3]天津中医药大学第二附属医院,天津300150 [4]沈阳市第七人民医院,沈阳110003 [5]辽宁省鞍山市中医院,鞍山114004

出　　处：《中华中医药杂志》2014年第4期1266-1269,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金："十一五"国家科技支撑计划项目(No.2008BAI53B012);国家自然科学基金项目(No.81173273);辽宁省自然科学基金项目(No.201202154);沈阳市科学技术项目(No.F12-277-1-73);辽宁省高等学校优秀人才支持计划项目(No.LJQ2012083)~~

摘　　要：目的:观察中医辨证外治对非严重缺血性糖尿病足的治疗作用。方法:5个分中心纳入229例非严重缺血性糖尿病足患者,随机分为中药治疗组和无菌换药对照组,以创面面积、创面深度、肿胀范围、肉芽组织生长、脓液情况为疗效指标,以血、尿、便常规、肝肾功、尿汞含量为安全性指标,对中医辨证外治的有效性和安全性进行临床观察。结果:所有病例均无不良反应发生。中药治疗组的愈显率为80.54%,与无菌换药对照组(68.00%)比较,差异有统计学意义(P<0.05)。两组治疗15、30、45、60d后创面面积相对基线的变化比较,差异均有统计学意义(P<0.01)。治疗后尿汞检测未见异常。结论:中医辨证外治对非严重缺血性糖尿病足安全、有效。Objective： To observe the effects of external treatment of TCM based on syndrome differentiation for non- severe ischemic diabetic foot. Methods： 229 patients of non-severe ischemic diabetic foot were randomly divided into TCM treatment group and the conventional treatment control group. Evaluated indexes included wound area, wound depth, swelling range, the growth of granulation tissue, and safety indexes included routine blood, urine, stool test, liver and kidney function, urine mercury levels. The efficacy and safety of external treatment of TCM based on syndrome differentiation were observed. Results： All the cases had no adverse reaction. The cured and markedly effective rate in TCM treatment group was 80.54%, compared with the conventional treatment control group （68.00%）, the difference was statistically significant （P〈0.05）. The wound surface area relative to the baseline of TCM treatment group, compared with the conventional treatment control group, the difference was statistically significant at fifteenth days, thirtieth days, forty-fifth days, sixtieth days after treatment （P〈0.01）. The mercury in the urine was detected no abnormal. Conclusion： The external treatment of TCM based on syndrome differentiation is a safe and effective method for non-severe ischemic diabetic foot.

关 键 词：糖尿病足 中医外治 辨证 

分 类 号：R259[医药卫生—中西医结合]