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高压氧疗法在糖尿病足溃疡治疗中的作用:一项针对肢体截肢和溃疡愈合的随机对照试验的系统评价和荟萃分析。

The role of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers: a systematic review with meta-analysis of randomized controlled trials on limb amputation and ulcer healing.

机构信息

Faculty of Medicine, University of Porto, Porto, Portugal -

Faculty of Medicine, University of Porto, Porto, Portugal.

出版信息

Int Angiol. 2022 Feb;41(1):63-73. doi: 10.23736/S0392-9590.21.04722-2. Epub 2021 Jul 8.

DOI:10.23736/S0392-9590.21.04722-2
PMID:34236155
Abstract

INTRODUCTION

Hyperbaric oxygen therapy (HBOT) is increasingly being used in the treatment of as diabetic foot ulcers (DFU). However, definitive evidence regarding its beneficial effects is still scarce. The present systematic review aims to analyze the role of HBOT in the prevention of limb amputation along with improvement of ulcer healing in patients with lower limbs DFU.

EVIDENCE ACQUISITION

Three databases were searched: PubMed, Scopus, and ISI Web of Knowledge. The search was enrolled during October 2020. Both titles and abstracts were examined by two independent reviewers. Only randomized controlled trials (RCTs) reporting a comparison between standard DFU treatment and standard treatment associated with HBOT were included. In all studies eligibility was assessed and data regarding studies characteristics, methods and considered outcomes was obtained. Odds ratio (OR) was used to evaluate amputation and complete ulcer healing rates. Percentage of ulcer reduction at two weeks was evaluated using the inverse variance method, and the values were compared using mean difference values. Meta-analysis was done using a fixed-effect model if I values were under 50%, and a random-effects model if not.

EVIDENCE SYNTHESIS

Eleven RCTs were included, with a total of 668 patients studied. Patients undergoing HBOT had lower risk of amputation (OR 0.53 95% CI 0.32-0.90, I=31%). No difference was found in minor amputations (OR 0.89 95% CI 0.35-2.24, I=69%). Regarding, healing rates, HBOT patients had greater chances of ulcer healing (OR 4,00 95% CI 1.54-10.44, I=70%). It has also shown higher percentage of ulcer area reduction after two weeks of treatment in the HBOT group (mean difference 23.19%; 95% CI 14.86-31.52; I=0%).

CONCLUSIONS

The present review offers evidence that adjuvant HBOT decreases risk of major amputation while promoting wound healing when combined to standard treatment in the management of DFU. These findings may have clinical relevance in a selected group of patients, yet further larger studies are still needed.

摘要

简介

高压氧治疗(HBOT)在治疗糖尿病足溃疡(DFU)中的应用越来越广泛。然而,关于其有益效果的明确证据仍然很少。本系统评价旨在分析 HBOT 在预防下肢 DFU 患者截肢和改善溃疡愈合方面的作用。

证据收集

在 PubMed、Scopus 和 ISI Web of Knowledge 三个数据库中进行了搜索。搜索于 2020 年 10 月进行。由两名独立的审查员检查标题和摘要。仅纳入比较标准 DFU 治疗与标准治疗联合 HBOT 的随机对照试验(RCT)。在所有研究中,均评估了纳入标准,并获得了关于研究特征、方法和考虑结果的数据。使用比值比(OR)评估截肢和完全溃疡愈合率。使用倒数方差法评估两周时溃疡减少的百分比,并使用均值差值比较值。如果 I ² 值低于 50%,则使用固定效应模型进行荟萃分析;如果 I ² 值不低于 50%,则使用随机效应模型进行荟萃分析。

证据综合

纳入了 11 项 RCT,共 668 名患者参与研究。接受 HBOT 的患者截肢风险较低(OR 0.53,95%CI 0.32-0.90,I=31%)。在小截肢方面无差异(OR 0.89,95%CI 0.35-2.24,I=69%)。关于愈合率,HBOT 患者溃疡愈合的可能性更大(OR 4.00,95%CI 1.54-10.44,I=70%)。HBOT 组在治疗两周后溃疡面积减少的百分比也更高(平均差异 23.19%,95%CI 14.86-31.52;I=0%)。

结论

本综述提供的证据表明,辅助 HBOT 可降低主要截肢的风险,同时促进伤口愈合,当与 DFU 标准治疗联合使用时。这些发现可能对特定患者群体具有临床意义,但仍需要进一步更大规模的研究。

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