煨脓长肉中医外治方案治疗Wagner 2~3级糖尿病足溃疡的临床疗效

Clinical Observation on Wagner 2-3 Diabetic Foot Ulcer Treated by TCM External Treatment Scheme for Euriching Pus for Tissue Growth

目的:观察煨脓长肉中医外治方案治疗Wagner 2~3级糖尿病足溃疡的临床疗效及安全性。方法:采用随机对照试验设计,2021年5月至2021年9月上海中医药大学附属曙光医院血管外科门诊及病房的96例患者随机分为观察组和对照组,每组48例,在两组患者接受基础治疗后,分为采用煨脓长肉外治方案和常规清创换药技术联合纳米银医用抗菌敷料的治疗方案,观察治疗前后两组患者的溃疡愈合率、溃疡面积、溃疡深度、中医证候评分、VAS评分、经皮氧分压、创面血流量、炎症因子(C-反应蛋白、白细胞介素-6、肿瘤坏死因子-α)、生长因子指标(血管内皮生长因子、转化生长因子-β1、成纤维细胞生长因子-β)、不良事件和终点事件。结果:与本组治疗前比较,两组患者的溃疡面积、溃疡深度、中医证候评分、VAS评分、C-反应蛋白、白细胞介素-6、肿瘤坏死因子-α、转化生长因子-β1均显著降低(P<0.01);经皮氧分压、创面血流量、血管内皮生长因子、成纤维细胞生长因子-β均显著升高(P<0.01)。治疗后观察组溃疡愈合率显著升高(P<0.01);溃疡面积、溃疡深度、VAS评分、经皮氧分压、创面血流量、C-反应蛋白、白细胞介素-6、肿瘤坏死因子-α、血管内皮生长因子、转化生长因子-β1、成纤维细胞生长因子-β的改善程度均显著优于对照组(P<0.01)。两组不良事件与终点事件发生差异无统计学意义。结论:煨脓长肉中医外治方案治疗Wagner 2~3级糖尿病足溃疡安全有效,不仅能够极大程度减小糖尿病足溃疡的面积和深度,改善中医证候评分、提高溃疡的愈合率,同时能够显著减轻患者疼痛,提高溃疡局部的微循环血流供应,其作用机制可能与降低创面局部的炎症反应,改善成纤维细胞和血管内皮细胞的增殖功能有关。

Objective:To observe the clinical efficacy and safety of traditional Chinese medicine(TCM)external therapeutic protocol of enriching pus for tissue growth(EPTG)in the treatment of Wagner 2-3diabetic foot ulcer.Method:The randomized controlled trial(RCT)design was adopted.Patients receiving basic treatment were divided into the EPTG group and the control group(debridement and change of nano-silver medical antibacterial dressing).Ulcer healing rate,ulcer area,ulcer depth,TCM symptom score,visual analogue scale(VAS),transcutaneous partial pressure of oxygen,wound blood flow,inflammatory factors[C-reactive protein(CRP),interleukin-6(IL-6),and tumor necrosis factor-α(TNF-α)],growth factors[vascular endothelial growth factor(VEGF),transforming growth factor-β1(TGF-β1),and fibroblast growth factor-β(FGF-β)],adverse events,and outcome events of the two groups before and after treatment were observed.Result:Compared with the conditions before treatment,the ulcer healing rate,ulcer area,ulcer depth,TCM symptom score,VAS score,transcutaneous partial pressure of oxygen,wound blood flow,CRP,IL-6,TNF-α,VEGF,TGF-β1,and FGF-βwere significantly improved(P<0.01).In terms of the improvement in the ulcer healing rate,ulcer area,ulcer depth,VAS score,transcutaneous partial pressure of oxygen,wound blood flow,CRP,IL-6,TNF-α,VEGF,TGF-β1,and FGF-β,the EPTG group was superior to the control group(P<0.01).There were no statistically significant differences in adverse events and outcome events between the two groups.Conclusion:The TCM external therapeutic protocol of EPTG is safe and effective in the treatment of Wagner 2-3 diabetic foot ulcer.It can greatly reduce the area and depth of diabetic foot ulcer,improve the ulcer healing rate and TCM symptom score,relieve the pain of patients,and improve the microcirculatory blood supply in the local ulcer.Its mechanism of action may be related to the reduction of the local inflammatory response of the wound and the improvement of the proliferation of fibroblasts and vascular endothelial cells.