局部创面氧疗治疗慢性糖尿病足溃疡的疗效:系统评价和荟萃分析。
Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis.
机构信息
Strategic Solutions, Inc., Bozeman, Montana, USA.
Diabetic Foot Consultants, Midwestern University, Glendale, Arizona, USA.
出版信息
Adv Wound Care (New Rochelle). 2023 Apr;12(4):177-186. doi: 10.1089/wound.2022.0041. Epub 2022 Jun 21.
To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy (TOT) as an adjunct therapy in the treatment of Wagner 1 and 2 diabetic foot ulcers. Following a literature search of eligible studies from 2010 onward, four RCTs were included. Studies were analyzed for patient and wound characteristics, outcomes, risk of bias, and quality of the evidence assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A random-effects meta-analysis for complete wound healing was carried out due to statistical heterogeneity of included studies. Risk of bias judgment (RoB2 analysis) resulted in one low-risk trial and three trials with some risk. One study was determined to be the origin of the statistical heterogeneity. Pooled results showed statistical significance with a risk ratio (RR) of 1.59 (95% confidence interval [CI]: 1.07-2.37; = 0.021). Sensitivity analysis, based on imputed values for missing outcomes, demonstrated that both the RR and 95% CIs changed little. The GRADE ratings for each domain were as follows: (a) risk of bias: moderate (3); (b) imprecision: moderate (2), high (1); (c) inconsistency: low (2), high (1); (d) indirectness: moderate (2), high (1); and (e) publication bias: moderate (1), high (2). Overall, the evidence was moderate. Our study shows that TOT is a viable diabetic foot ulcer therapy. These data support the use of TOT for the treatment of chronic Wagner 1 or 2 diabetic foot ulcers in the absence of infection and ischemia.
对 2010 年以来发表的、采用局部氧疗(TOT)作为辅助治疗方法治疗 Wagner 1 级和 2 级糖尿病足溃疡的随机对照试验(RCT)进行系统评价和荟萃分析。通过对合格研究的文献检索,共纳入 4 项 RCT。分析患者和伤口特征、结局、偏倚风险以及使用推荐评估、制定与评估(GRADE)方法学评估证据质量。由于纳入研究存在统计学异质性,因此对完全愈合进行了随机效应荟萃分析。偏倚风险判断(RoB2 分析)结果显示,1 项试验为低风险,3 项试验为存在一定风险。有一项研究被确定为统计学异质性的来源。汇总结果显示,风险比(RR)为 1.59(95%置信区间[CI]:1.07-2.37; = 0.021)具有统计学意义。基于缺失结局的推断值进行敏感性分析表明,RR 和 95%CI 变化不大。每个领域的 GRADE 评分如下:(a)偏倚风险:中度(3);(b)不精确性:中度(2),高(1);(c)不一致性:低(2),高(1);(d)间接性:中度(2),高(1);(e)发表偏倚:中度(1),高(2)。总的来说,证据质量为中等。本研究表明 TOT 是一种可行的糖尿病足溃疡治疗方法。这些数据支持在没有感染和缺血的情况下,使用 TOT 治疗慢性 Wagner 1 或 2 级糖尿病足溃疡。