【目的】 观察伤科黄水外敷对红肿祛腐期糖尿病足患者创面愈合及血清甲基乙二醛（methylglyoxal，MG）含量的影响，评 估其临床疗效及安全性，并探讨伤科黄水治疗糖尿病足的作用途径。【方法】 将72例处于红肿祛腐期的糖尿病足患者随机分 为治疗组和对照组，每组各36例。2组患者均给予控制血糖、营养神经、控制感染、改善循环等基础治疗，在此基础上，对 照组给予局部清创处理和安尔碘外敷治疗，治疗组给予对照组相同的糖尿病足创面清创处理和伤科黄水外敷治疗，疗程为 14 d。观察2组患者治疗前后创面面积和深度、创面分泌物培养情况、中医证候积分及血清MG水平和血糖指标的变化情况， 并评价 2 组患者的临床疗效和安全性。【结果】（1）治疗 14 d 后，治疗组的总有效率为 93.54%（29/31），对照组为 81.25% （26/32），组间比较，治疗组的疗效明显优于对照组（P＜0.05）。（2）治疗后，2组患者的创面面积和深度、病原菌检出率、中 医证候主症积分和次症积分以及血清MG水平和空腹血糖（FBG）、餐后2 h血糖（2hPG）水平均较治疗前明显降低（P＜0.05 或P＜0.01），且治疗组对上述指标（除血糖指标外）的改善幅度均明显优于对照组（P＜0.05 或 P＜0.01）。（3）治疗期间，2 组患 者均无明显不良反应发生，且患者的肝肾功能指标均未见异常，具有较高的安全性。【结论】 基于中医外治法，采用伤科黄 水纱外敷治疗红肿祛腐期糖尿病足患者疗效确切，有利于促进创面愈合，改善患者临床症状，降低与糖尿病发生、发展相 关的代谢指标血清MG含量，提示伤科黄水的作用机制可能与降低血清MG水平有关。

Objective The effect of external application of Shangke Huangshui Medicated Gauze on wound healing and serum methylglyoxal（MG）level in the patients with diabetic foot in the swelling and ulcer stage was observed to evaluate its clinical efficacy and safety and to explore its therapeutic mechanism for diabetic foot. Methods A total of 72 patients with diabetic foot in the swelling and ulcer stage were randomly divided into treatment group and control group， with 36 cases in each group. The patients in the two groups were given basic treatment such as controlling blood glucose，nourishing the nerves，controlling infection and improving circulation. Additionally， the control group was given focal debridement and external application of Anerdian Medical Iodine， and the treatment group was given the same focal debridement as the control group together with external application of Shangke Huangshui Medicated Gauze. The course of treatment lasted for 14 days. The changes of wound area and depth of the ulcer，bacterial culture of wound secretion，traditional Chinese medicine（TCM）syndrome score， serum MG level and blood glucose indicator levels in the two groups were observed before and after treatment. After treatment，the clinical efficacy and safety of the two groups were evaluated. Results（1）After 14 days of treatment， the total effective rate in the treatment group was 93.54%（29/31）and that in the control group was 81.25%（26/32）. The intergroup comparison showed that the efficacy of the treatment group was significantly superior to that of the control group（P＜0.05）.（2）After treatment， the wound area and depth， the detection rate of pathogenic bacteria，the scores of primary symptoms and secondary symptoms of TCM syndromes，and the levels of serum MG， fasting blood glucose（FBG） and 2-hour postprandial blood glucose（2hPG） in the two groups were significantly lower than those before treatment（P＜0.05 or P＜0.01）， and the improvement of the above parameters（except for blood glucose indicators）in the treatment group was superior to that in the control group （P＜0.05 or P＜0.01）.（3）During the treatment period，there were no obvious adverse reactions occurring in the two groups，and there were no abnormalities of the liver and kidney function indicators of the patients in the two groups，which had high safety. Conclusion The external application of Shangke Huangshui Medicated Gauze，a TCM external treatment method，is effective for the treatment of diabetic foot patients in the swelling and ulcer stage，which is beneficial to promote wound healing，relieve the clinical symptoms of patients，and decrease the level of MG which is associated with the development and progression of diabetes. The therapeutic mechanism of Shangke Huangshui Medicated Gauze may be related to the decrease of serum MG level.

R259.872

佛山市自筹经费类科技计划项目（编号：2020001005691）