Efficacy Of Transdermal Continuous Oxygen Therapy For Diabetic Foot Ulcer:a Meta-analysis Of Randomized Controlled Clinical Trials

Objective:Diabetic foot ulcer and its complications have been more and more harmful to people's health.Over the past decade,several growth factors and their combined applications have shown the potential to accelerate the healing of diabetic foot ulcers.Epidermal growth factor is one of the most studied growth factors,and the conclusions on its effectivenessin existing studies are still not unified,so it is necessary to systematically evaluate and summarize relevant evidence.The purpose of this study was to provide the best evidence for clinical treatment of diabetic foot ulcers by systematically evaluating the efficacy and safety of epidermal growth factor.Methods:We made a comprehensive retrieval of Pub Med,EMBASE,Cochrane library,CNKI,Wan Fang and Vip databases by computer.The retrieval method was the combination of subject words and free words,and tried to search for synonyms.The English search terms were epidermal growth factor,EGF,rh EGF,diabetic foot,diabetic ulcer,diabetic wound,DFU;The Chinese search terms were??????,???,EGF,rh EGF,????,?????,???,???.References of all relevant articles were also screened.Rev Man 5.3 software was used to perform the analysis.We presented dichotomous outcomes as risk ratios(RRs)and corresponding 95%CIs.For continuous outcomes,we used mean differences(MD)and 95%CIs as the measure of treatment effects.I2 was used to evaluate interstudy heterogeneity.If there is homogeneous between studies,we used a fixed effects model analysis.If the studies are obvious heterogeneity,the random effect model or subgroup analysis will be adopted after analyzing the sources of heterogeneity.Results:A total of 589 studies were initially retrieved and eventually included in 16 randomized controlled studies after careful screening.The included studies contained 7English articles and 9 Chinese articles,with a sample size ranging from 30 to 167.The Cochrane risk bias method was used for quality assessment,and the quality score of 7articles was greater than or equal to 3 points.The results of Meta analysis showed that the number of patients with ulcer healing was higher in the rh EGF group at different treatment periods(2 weeks to 12 weeks),and the difference was statistically significant(RR=1.54;P < 0.00001;I2 = 0%).After sensitivity analysis and exclusion of poor-quality literatures,no significant changes were observed in meta analysis results(RR=1.51;P <0.00001;I2=0%),showing good stability.rh EGF group had a higher proportion of wounds completely healed no matter topical application(RR=1.58;P<0.00001;I2=0%)or intralesional injection(RR=1.35;P=0.06;I2=50%).In terms of adverse reactions,the number of chills and nausea/vomiting in the rh EGF group was higher than that in the control group,and the degrees were described as mild and easy to control.Other adverse events showed no significant difference,indicating good safety.Conclusion:Topical recombinant human epidermal growth factor has been shown to be effective in treating diabetic foot ulcers at different stages and with different local treatments.The difference of adverse reactions between the two group was small and mild,indicating a good safety.