五味消毒饮与重组人酸性成纤维细胞生长因子联合灌洗在负压封闭引流技术辅助下治疗糖尿病足溃疡的临床研究OA

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.