【目的】观察八珍汤联合黄油纱治疗糖尿病足溃疡 （diabetic foot ulcer，DFU） 气血两虚证患者的临床疗效。 【方法】将42例DFU气血两虚证患者随机分为对照组和观察组，每组各21例。对照组给予西医基础内科治疗及黄油纱外敷创面局部治疗，观察组在对照组的基础上加用八珍汤治疗，疗程为4周。观察2组患者治疗前后创面面积、中医证候积分、踝肱指数 （ABI）及血清纤维蛋白原 （FIB） 、C反应蛋白 （CRP） 、肿瘤坏死因子α （TNF-α） 水平的变化情况，并比较2组患者的临床疗效及治疗方案的安全性。 【结果】（1） 治疗4周后，观察组的总有效率为95.24% （20/21） ，对照组为85.71% （18/21） ，组间比较 （秩和检验） ，观察组的临床疗效明显优于对照组 （P＜0.05） 。 （2） 治疗后，2组患者的创面面积及中医证候积分均较治疗前明显改善（P＜0.05） ，且观察组对创面面积及中医证候积分的改善作用均明显优于对照组 （P＜0.05） 。 （3） 治疗后，2组患者的ABI均较治疗前升高 （P＜0.05） ，且观察组对ABI的升高作用明显优于对照组 （P＜0.05） 。 （4） 治疗后，2组患者血清CRP、TNF-α、FIB水平均较治疗前降低 （P＜0.05） ，且观察组对血清CRP、TNF-α、FIB水平的降低作用均明显优于对照组 （P＜0.05）。（5） 治疗过程中，2组患者均未发生明显不良反应，具有较高的安全性。 【结论】八珍汤联合黄油纱治疗DFU气血两虚证患者疗效确切，可有效改善患者的凝血功能及下肢动脉缺血情况，降低炎症因子水平，减轻炎症反应，且无明显不良反应。

Objective To observe the clinical efficacy of Bazhen Decoction combined with traumatic medicated gauze（prepared mainly with the herbs of Scutellariae Radix，Phellodendri Chinensis Cortex and Sanguisorbae Radix） in the treatment of patients with diabetic foot ulcer（DFU） of qi-blood deficiency syndrome. Methods A total of 42 cases of DFU patients with qi-blood deficiency syndrome were randomly divided into a control group and an observation group，with 21 cases in each group. The control group was given basic western medicine treatment combined with external application of traumatic medicated gauze on wound surface，while the observation group was treated with Bazhen Decoction orally on the basis of treatment for the control group，and the treatment course of both groups covered four weeks. The changes of wound area，traditional Chinese medicine （TCM） syndrome scores，ankle-brachial index （ABI），and serum levels of fibrinogen（FIB），C-reactive protein（CRP），tumor necrosis factor α （TNF-α） in the two groups were observed before and after treatment. After treatment，the clinical efficacy and safety in the two groups were compared. Results （1） After four weeks of treatment，the total effective rate in the observation group was 95.24%（20/21） and that in the control group was 85.71%（18/21），and the intergroup comparison （by rank sum test） showed that the clinical efficacy in the observation group was significantly superior to that in the control group （P＜0.05） . （2） After treatment，the wound area and TCM syndrome scores in the two groups were significantly improved compared with those before treatment （P＜0.05） ，and the improvement of the wound area and TCM syndrome score in the observation group was significantly superior to that in the control group（P＜0.05） . （3）After treatment，ABI in the two groups was increased when compared with that before treatment （P＜0.05） ，and the improvement of ABI in the observation group was significantly superior to that in the control group （P＜0.05） . （4） After treatment，the levels of serum CRP，TNF-α and FIB in the two groups were all decreased compared with those before treatment（P＜0.05），and the improvement of the serum levels in the observation group was significantly superior to that in the control group （P＜0.05） . （5） During the treatment，there were no significant adverse reactions occurring in the two groups，with high safety. Conclusion Bazhen Decoction combined with traumatic medicated gauze exerts certain effect in the treatment of DFU patients with qi-blood deficiency syndrome. The combined therapy is effective on improving the coagulation function and lower limb ischemia，reducing the levels of inflammatory factors，and relieving the inflammatory reaction，without obvious adverse reactions.

R259.872

广东省医学科研基金资助项目 （编号：B2021340）