Transdermal continuous oxygen therapy repairs diabetic foot ulcer: a systematic review

doi:10.3969/j.issn.2095-4344.1261

Abstract

Abstract:

BACKGROUND: Transdermal continuous oxygen therapy is a new and painless method for treating diabetic foot ulcer. The conclusions of existing studies on whether it can accelerate the repair of diabetic foot ulcer are still not unified, and it needs systematic evaluation.
OBJECTIVE: To systematically evaluate the efficacy and safety of transdermal continuous oxygen therapy in the management of diabetic foot ulcer.
METHODS: We systematically searched PubMed, EMBASE, Cochrane library, ClinicalKey, CNKI, WanFang, and VIP databases for randomized controlled trials on assessing the efficacy of transdermal continuous oxygen therapy (trial group) and placebo/blank control (control group) in diabetic foot ulcer. Meta-analysis was conducted on RevMan 5.3 software.
RESULTS AND CONCLUSION: Four randomized controlled trials involving 311 patients were included. The meta-analysis results suggested that the proportion of complete ulcer healing in the trial group was higher than that in the control group, but the difference was insignificant [RR=1.73, 95%CI (0.91, 3.30), P=0.10]. The incidence of adverse events [RR=0.63, 95%CI (0.41, 0.98), P=0.04] and the incidence of new foot infection [RR=0.47, 95%CI (0.26, 0.85), P=0.01] in the trial group were lower than those in the control group. These results indicate that transdermal continuous oxygen therapy has high safety and can reduce the incidence of infection to some extent, but the current evidence does not show that it can obviously increase the healing rate of diabetic foot ulcer.

Key words: diabetic foot, chronic wound, transdermal continuous oxygen therapy, non-healing ulcer, oxygen therapy, topical oxygen therapy, soft tissue repair, construction of skin and mucosa tissue, meta-analysis, systematic review, randomized controlled trial

CLC Number:

Yang Qi, Zhang Yonghong, Lu Yanjun. Transdermal continuous oxygen therapy repairs diabetic foot ulcer: a systematic review [J]. Chinese Journal of Tissue Engineering Research, 2019, 23(23): 3767-3772.

Figures/Tables 3

2.3 Meta分析结果 2.3.1 伤口愈合(在治疗期间溃疡完全愈合的比例) 共3项研究包括251例参与者显示了在治疗期间溃疡完全愈合的比例[9，12，14]，这3项研究的随访时间分别为12周[9]，12周[12]，8周[14]。各研究间存在实质的异质性(P=0.04，I2=69%)，故选用随机效应模型。结果显示：与对照组相比，试验组溃疡完全愈合的比例较高，但差异无显著性意义[53.2%，36.0%，RR=1.73，95%CI(0.91，3.30)，P=0.10]，见图3。由于纳入文献较少，估计的置信区间很宽，结果较为保守。 2.3.2 溃疡面积/体积变化率 1项研究报道了治疗开始后8周内每周溃疡面积的变化[14]，包括18例参与者，结果为：试验组溃疡面积在第2-8周较基线伤口大小显著减小[第2周(P < 0.016)，第3周(P < 0.09)，第4周(P < 0.002)，第5周(P < 0.001)，第6周(P < 0.001)，第7周(P < 0.001)，第8周(P < 0.001)]，对照组伤口面积大小变化无显著性意义[F(1.186，10.674)=1.447，P < 0.262]。由于研究样本量少，原始试验的偏倚风险不明确，证据质量低。 1项包括17例参与者的研究报道了治疗开始后4周内溃疡体积的变化[13]，第4周时，试验组溃疡体积减少约87%(55.7%-100.0%)，对照组减少约46%(15%-99%)，试验组第4周溃疡体积减少百分比显著高于对照组(P < 0.05)。但由于结果数据未具体描述且样本量少，原始试验的偏倚风险不明确，证据质量低。 2.3.3 完成伤口愈合的时间没有研究报道该结果的有效数据。虽然2篇文献报道了溃疡愈合的中位时间[9，12]，但因为并非所有的溃疡都得到了治愈，所以对溃疡愈合时间的评估并不可靠，未将数据进行定量分析。 2.3.4 不良事件发生率共2项研究包括276例参与者报道了不良事件的发生信息[9，12]，所报道不良事件种类包括患肢伤口周围感染、水肿、脓肿、骨髓炎、坏疽、再截肢、菌血症。使用固定效应模型分析得出结果：与对照组相比，试验组不良事件发生率较低[18.2%，29.0%；RR=0.63，95%CI(0.41，0.98)，P=0.04]，见图4。 2.3.5 感染发生率共2项研究包括276例参与者报道了溃疡周围感染的相关信息[9，12]。使用固定效应模型分析显示，试验组新发感染发生率较对照组更低[10.1%，21.7%；RR=0.47，95%CI(0.26，0.85)，P=0.01]，见图5。 2.3.6 坏疽/截肢发生率共2项研究包括276例参与者报告了坏疽/截肢的发生信息[9，12]，结果为试验组无坏疽或截肢发生，对照组有1例参与者发生截肢，3例参与者发生足部坏疽。因为样本量及阳性结果均较少，未对其行统计学分析。"

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