Xiaozhong Zhitong Mixture（消肿止痛合剂）Combined with Antibiotic Bone Cement in the Treatment of Diabetic Foot Ulcers with Damp-Heat Obstructing Syndrome：A Randomized Controlled Trial of 35 Patients
10.13288/j.11-2166/r.2025.07.009
- VernacularTitle:消肿止痛合剂联合抗生素骨水泥治疗糖尿病足溃疡湿热阻滞证患者35例随机对照试验
- Author:
Xiaotao WEI
1
;
Zhijun HE
1
;
Tao LIU
1
;
Zhenxing JIANG
1
;
Fei LI
1
;
Yan LI
1
;
Jinpeng LI
1
;
Wen CHEN
1
;
Bihui BAI
1
;
Xuan DONG
2
;
Bo SUN
2
Author Information
1. Gansu Provincial Hospital of Traditional Chinese Medicine，Lanzhou，730000
2. Gansu University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
diabetic foot ulcer;
damp-heat obstructing syndrome;
Xiaozhong Zhitong Mixture （消肿止痛合剂）;
antibiotic bone cement;
inflammatory response;
oxidative stress;
randomized controlled trial
- From:
Journal of Traditional Chinese Medicine
2025;66(7):704-709
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical effectiveness and safety of Xiaozhong Zhitong Mixture （消肿止痛合剂） combined with antibiotic bone cement in the treatment of diabetic foot ulcer （DFU） with damp-heat obstructing syndrome. MethodsA total of 72 DFU patients with damp-heat obstructing syndrome were randomly assigned to treatment group （36 cases） and the control group （36 cases）. Both groups received standard treatment and topical antibiotic bone cement for ulcer wounds， while the treatment group received oral Xiaozhong Zhitong Mixture （50 ml per time， three times daily） in additionally. Both groups underwent daily wound dressing changes for 21 consecutive days. Ulcer healing rate， serum levels of tumor necrosis factor-alpha （TNF-α）， interleukin-1 beta （IL-1β）， malondialdehyde （MDA）， superoxide dismutase （SOD）， C-reactive protein （CRP）， and white blood cell （WBC） count were observed before and after treatment， and visual analog scale （VAS） scores for wound pain， traditional Chinese medicine （TCM） syndrome scores， and the DFU Healing Scale （DMIST scale） were also compared. Liver and kidney function were evaluated before and after treatment， and adverse events such as allergic reactions， worsening ulcer pain were recorded. ResultsTotally 35 patients in the treatment group and 33 in the control group were included in the final analysis. The ulcer healing rate in the treatment group was （87.93±9.34）%， significantly higher than （81.82±12.02）% in the control group （P = 0.035）. Compared to pre-treatment levels， both groups showed significant reductions in serum CRP， WBC， MDA， IL-1β， and TNF-α levels， with an increase in SOD level （P＜0.05）. TCM syndrome scores， VAS， and DMIST scores also significantly decreased in both groups （P＜0.05）， with greater improvements in the treatment group （P＜0.05）. No significant adverse reactions were observed in either group during treatment. ConclusionXiaozhong Zhitong Mixture combined with antibiotic bone cement has significant advantages in promoting DFU healing， reducing inflammatory response， and alleviating oxidative stress in DFU patients with damp-heat obstructing syndrome， with good safety for DFU patients with damp-heat obstructing syndrome.
