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高压氧疗法治疗糖尿病足溃疡的疗效:一项对照临床试验的系统评价和荟萃分析。

Efficacy of hyperbaric oxygen therapy for diabetic foot ulcer, a systematic review and meta-analysis of controlled clinical trials.

机构信息

College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.

Akal College of Nursing, Eternal University, Baru Sahib, Himachal Pradesh, India.

出版信息

Sci Rep. 2021 Jan 26;11(1):2189. doi: 10.1038/s41598-021-81886-1.

Abstract

Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14-0.61; I = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39-0.92; I = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34-1.97; I = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07-2.65; I = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.

摘要

研究表明高压氧疗法(HBOT)对糖尿病足溃疡(DFU)的愈合有效,但尚未达成共识。因此,为了评估 HBOT 对糖尿病患者的糖尿病足溃疡的疗效,通过 PubMed、EMBASE、Clinical key、ovid Discovery、ERMED、Clinical Trials.gov 数据库搜索对照临床试验(RCT)和其他来源,直到 2020 年 9 月 15 日。纳入评估 HBOT 对糖尿病足溃疡、完全愈合、截肢、不良事件、溃疡面积减少和死亡率影响的研究。在筛选出的 1984 项研究记录中,根据纳入标准纳入了 14 项研究(768 名参与者),包括 12 项 RCT 和 2 项 CCT。荟萃分析结果表明,HBOT 对糖尿病足溃疡的完全愈合(OR=0.29;95%CI 0.14-0.61;I=62%)和主要截肢(RR=0.60;95%CI 0.39-0.92;I=24%)有显著疗效。虽然对小截肢(RR=0.82;95%CI 0.34-1.97;I=79%)无效;但标准治疗组报告的不良事件较少(RR=1.68;95%CI 1.07-2.65;I=0%)。然而,HBOT 组和对照组的平均溃疡面积减少率和死亡率无差异。本综述提供的证据表明,高压氧疗法作为糖尿病足溃疡的辅助治疗措施是有效的。考虑到所有研究中的方法学缺陷,这些发现可以谨慎推广。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf7c/7838311/149618921d3e/41598_2021_81886_Fig1_HTML.jpg

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