Thanigaimani Shivshankar, Singh Tejas, Golledge Jonathan
The Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), College of Medicine and Dentistry, James Cook University, Queensland, Australia.
The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia.
Diabet Med. 2021 Aug;38(8):e14585. doi: 10.1111/dme.14585. Epub 2021 Apr 29.
Topical oxygen therapy (TOT) has been suggested as a treatment for diabetes-related foot ulcer (DFU) but no prior meta-analyses of randomised clinical trials (RCT) have been reported. This systematic review and meta-analysis examined the randomised evidence for the benefit of TOT in healing DFU.
Publicly available databases were searched for RCTs investigating the effect of TOT on wound healing in participants with a DFU. The primary outcome was ulcer healing defined as full epithelialisation. Meta-analyses were performed using random effect models and reported as risk ratios (RR) and 95% confidence intervals (CI). Study quality and publication bias were assessed using a modified version of the Cochrane Collaboration's tool and funnel plots, respectively.
Six RCTs involving 530 participants with a DFU testing TOT were included. Meta-analysis suggested that TOT significantly increased the likelihood of ulcer healing compared to controls (Risk ratio [RR] 1.94; 95% CI 1.19, 3.17; I = 57%; NNT = 5.33) and findings were robust in sensitivity analyses. Risk of bias was high, moderate and low in two, one and three studies, respectively. Analysis of the three trials judged to be at low risk of bias suggested that TOT increased the likelihood of ulcer healing compared to controls (RR 2.37; 95% CI 1.52, 3.68; I = 0%). Funnel plots suggested the possibility of publication bias. Data on amputation were too limited for meta-analysis.
This meta-analysis suggests that TOT improves the likelihood of DFU healing; however, its effect on amputation and cost-effectiveness are unclear.
局部氧疗（TOT）已被提议作为糖尿病相关足部溃疡（DFU）的一种治疗方法，但此前尚无关于随机临床试验（RCT）的荟萃分析报道。本系统评价和荟萃分析考察了TOT对DFU愈合有益的随机证据。
检索公开可用数据库，查找调查TOT对DFU患者伤口愈合影响的RCT。主要结局为溃疡愈合，定义为完全上皮化。采用随机效应模型进行荟萃分析，并报告为风险比（RR）和95%置信区间（CI）。分别使用Cochrane协作网工具的修订版和漏斗图评估研究质量和发表偏倚。
纳入了6项涉及530例接受TOT治疗的DFU患者的RCT。荟萃分析表明，与对照组相比，TOT显著增加了溃疡愈合的可能性（风险比[RR]1.94；95%CI 1.19，3.17；I² = 57%；NNT = 5.33），敏感性分析结果稳健。两项、一项和三项研究的偏倚风险分别为高、中和低。对三项被判定为低偏倚风险的试验进行分析表明，与对照组相比，TOT增加了溃疡愈合的可能性（RR 2.37；95%CI 1.52，3.68；I² = 0%）。漏斗图提示存在发表偏倚的可能性。截肢数据过于有限，无法进行荟萃分析。
本荟萃分析表明，TOT提高了DFU愈合的可能性；然而，其对截肢和成本效益的影响尚不清楚。
