【摘要】 目的通过规范的临床研究,产生糖尿病足溃疡期中医综合外治方案、技术操作规范以及客观的疗效评价标准,为该病诊疗指南提供临床基础。方法采用第三方数据管理中央随机、阳性对照、多中心临床试验设计方案,总结190例全国5家分中心共同研究得出的针对糖尿病足溃疡期Ⅱ~Ⅳ级中医综合外治方案。结果创面临床痊愈率、创面闭合指数、疾病疗效、证候疗效中医治疗1组、2组分别与对照组比较,差别有统计学意义(P<0.05),治疗1组与治疗2组无差别(P>0.05)。结论固本箍毒、祛腐生新为糖尿病足溃疡治疗原则,中医综合外治方案是减毒、控毒、最大化地保留尚有功能的组织,此方案应用于糖尿病足溃疡的治疗,经科学的测量与中医症状量化评价标准检验,疗效肯定。更多还原

【Abstract】 Objective To establish TCM comprehensive external treatment plans, manipulation specification and curative effect evaluation standard of ulcer period of diabetic foot for providing the therapeutic guide through standardized clinical study. Methods The plan of central randomized, positive controlled and multi-center clinical trials were managed by applying the third-party data, and TCM comprehensive external treatment plans for ulcer period of diabetic foot from grade Ⅱ to grade Ⅳ were summed up in 190 cases studied by national 5 branch-centers. Results The differences in wound healing rate, wound closure index, curative effect of disease and curative effect of syndromes had statistical significance respectively compared between treatment group 1 or treatment group 2 and control group (P<0.05). There was no difference between treatment group 1 and treatment group 2(P>0.05) Conclusion The therapeutic principles for ulcer period of diabetic foot is supporting the root and binding toxin, and dispelling putridity and promoting regeneration. TCM comprehensive external treatment plans are effective therapies for reducing and controlling toxin, and keeping the maximum of functional tissues. The plans, with scientific measures and tests of TCM syndrome quantification evaluation and reliable curative effect, canbe used in the treatment of ulcer period of diabetic foot.更多还原