【目的】探讨在负压封闭引流（VSD）技术基础上，采用重组人酸性成纤维细胞生长因子（rh-aFGF）、五味消毒饮联合 rh-aFGF 两种灌洗策略对糖尿病足溃疡（DFU）患者创面修复效果的影响，为临床优化VSD 技术治疗方案提供参考。【方法】选 取2021 年5 月至2022 年12 月河北省中医院周围血管外科收治的符合纳入标准的DFU 湿热毒蕴、筋腐肉烂证患者，共80 例。 按照随机数字表法将患者随机分为对照组和观察组，每组各40 例。2 组均采用VSD 技术治疗，对照组采用rh-aFGF 灌注冲洗 治疗，观察组采用五味消毒饮联合rh-aFGF 灌注冲洗治疗，2 组疗程均为7 周。观察并比较2 组患者的创面愈合时间、肉芽 组织生长情况及感染控制指标、炎症指标、氧化应激指标的变化情况，评价2 组患者的临床疗效和治疗方案的安全性。 【结果】（1）脱落情况方面，研究过程中，对照组1 例患者、观察组2 例患者脱落，最终共有77 例患者完成全部疗程的治疗和 随访，其中对照组39 例，观察组38 例。（2）疗效方面，治疗7 周后，观察组的总有效率为94.74%（36/38），对照组为79.49% （31/39），组间比较（χ2 检验），观察组的疗效明显优于对照组（P＜0.05）。（3）创面愈合情况方面，观察组的创面面积缩小率和 肉芽组织生长情况均明显优于对照组（P＜0.05）；对7 周内创面实现外科闭合且完全愈合的患者进行亚组分析，观察组的肉 芽组织饱满时间和创面愈合时间均显著短于对照组（P＜0.01）。（4）感染控制指标方面，观察组的创面分泌物细菌培养转阴率 及Wagner 分级改善率均明显优于对照组（P＜0.05），对国际糖尿病足工作组/美国感染病学会（IWGDF/IDSA）感染评分的改善 幅度也明显优于对照组（P＜0.01）。（5）炎症指标方面，治疗后，2 组患者的C 反应蛋白（CRP）、降钙素原（PCT）、白细胞计数 （WBC）水平均较治疗前下降（P＜0.05），且观察组的下降幅度均明显优于对照组（P＜0.05 或P＜0.01）。（6）氧化应激指标方面， 治疗后，2 组患者的血清超氧化物歧化酶（SOD）、谷胱甘肽过氧化物酶（GSH-Px）水平均较治疗前升高（P＜0.05），血清丙二 醛（MDA）水平均较治疗前下降（P＜0.05），且观察组对血清SOD、GSH-Px 水平的升高幅度及对血清MDA 水平的下降幅度均 明显优于对照组（P＜0.05 或P＜0.01）。（7）安全性方面，完成随访的77 例患者均未出现严重不良事件，观察组和对照组各观 察到轻度不良反应1 例，均是在贴膜后出现局部皮肤瘙痒，经处理后未影响后续治疗。【结论】在VSD 技术辅助下，五味消毒 饮联合rh-aFGF 灌洗能更有效地促进DFU 创面愈合，降低炎症反应和氧化应激，其疗效优于单一灌洗治疗，具有较高的临 床应用价值。

Objective To investigate the effects of two lavage strategies，recombinant human acidic fibroblast growth factor（rh-aFGF）alone and Wuwei Xiaodu Yin combined with rh-aFGF，on wound repair in patients with diabetic foot ulcers（DFU）under vacuum sealing drainage（VSD），thereby providing a reference for optimizing VSD-based therapeutic protocols. Methods A total of 80 patients with DFU manifesting as damp-heat toxin accumulation with sinew putrefaction and flesh rot syndrome，who were admitted to the Department of Peripheral Vascular Surgery of Hebei Provincial Hospital of Traditional Chinese Medicine from May 2021 to December 2022 and met the inclusion criteria were enrolled. Using a random number table，the patients were divided into a control group and an observation group，with 40 cases in each group. Both groups received VSD therapy；the control group was treated with rh-aFGF perfusion and irrigation，while the observation group was treated with Wuwei Xiaodu Yin combined with rh-aFGF perfusion and irrigation. The treatment course for both groups was 7 weeks. The wound healing time，granulation tissue growth，infection control indicators，inflammatory markers，and oxidative stress indicators were observed and compared between the two groups. Additionally，the clinical efficacy and safety of the treatment protocols were evaluated. Results（1）Regarding patient’s dropout，one patient in the control group and two in the observation group discontinued during the study，leaving a total of 77 patients who completed the full treatment and follow-up（39 in the control group and 38 in the observation group）.（2）In terms of efficacy，after 7 weeks of treatment，the total effective rate was 94.74%（36/38）in the observation group and 79.49%（31/39）in the control group，with intergroup comparison（by chi-square test）showing significantly better efficacy in the observation group（P＜0.05）.（3）Regarding wound healing，the observation group demonstrated significantly superior wound area reduction rate and granulation tissue growth compared with the control group（P＜ 0.05）；in the subgroup analysis of patients achieving surgical closure and complete healing within 7 weeks，the observation group exhibited significantly shorter granulation tissue filling time and wound healing time than the control group（P＜0.01）.（4）For infection control indicators，the observation group showed significantly better bacterial negative conversion rate in the culture of wound secretions and improvement rate in Wagner grading compared with the control group（P＜0.05），as well as a significantly greater reduction in the International Working Group on the Diabetic Foot/Infectious Diseases Society of America（IWGDF/IDSA）infection score（P＜ 0.01）.（5）Regarding inflammatory markers， after treatment，the levels of C-reactive protein（CRP）， procalcitonin（PCT），and white blood cell count（WBC）in both groups decreased compared with pretreatment levels（P＜0.05），with the observation group showing significantly greater reductions than the control group（P＜ 0.05 or P＜0.01）.（6）For oxidative stress indicators，after treatment，the serum levels of superoxide dismutase （SOD）and glutathione peroxidase（GSH-Px）increased in both groups compared with pretreatment levels（P＜ 0.05），while serum malondialdehyde（MDA）levels decreased（P＜0.05）. The observation group demonstrated significantly greater increases in SOD and GSH-Px levels and a significantly greater decrease in MDA level compared with the control group（P＜0.05 or P＜0.01）.（7）In terms of safety，none of the 77 patients who completed the follow-up experienced serious adverse events. Mild adverse reactions were observed in one patient in each group（local skin pruritus after dressing application），which were managed without affecting subsequent treatment. Conclusion Assisted by VSD technology，lavage with Wuwei Xiaodu Yin combined with rh-aFGF promotes wound healing in DFU，alleviates inflammatory response，and ameliorates oxidative stress more effectively，demonstrating superior efficacy to single-agent lavage and holding high clinical application value.

R259.872

国家自然科学基金资助项目（编号：81603412）；河北省中医药管理局科研计划项目（编号：2022050，2026019）