辅助性全身高压氧疗法治疗重度缺血性糖尿病足溃疡：一项随机研究。

Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer. A randomized study.

作者信息

Faglia E, Favales F, Aldeghi A, Calia P, Quarantiello A, Oriani G, Michael M, Campagnoli P, Morabito A

机构信息

Diabetology Center, Niguarda Hospital, Milan, Italy.

出版信息

Diabetes Care. 1996 Dec;19(12):1338-43. doi: 10.2337/diacare.19.12.1338.

DOI:10.2337/diacare.19.12.1338

PMID:8941460

Abstract

OBJECTIVE

To evaluate the effectiveness of systemic hyperbaric oxygen therapy (s HBOT) in addition to a comprehensive protocol in decreasing major amputation rate in diabetic patients hospitalized for severe foot ulcer.

RESEARCH DESIGN AND METHODS

From August 1993 to August 1995, 70 diabetic subjects were consecutively admitted into our diabetologic unit for foot ulcers. All the subjects underwent our diagnostic-therapeutic protocol and were randomized to undergo s-HBOT. Two subjects, one in the arm of the treated group and one in the arm of nontreated group, did not complete the protocol and were therefore excluded from the analysis of the results. Finally, 35 subjects received s-HBOT and another 33 did not.

RESULTS

Of the treated group (mean session = 38.8 +/- 8), three subjects (8.6%) underwent major amputation: two below the knee and one above the knee. In the nontreated group, 11 subjects (33.3%) underwent major amputation: 7 below the knee and 4 above the knee. The difference is statistically significant (P = 0.016). The relative risk for the treated group was 0.26 (95% CI 0.08-0.84). The transcutaneous oxygen tension measured on the dorsum of the foot significantly increased in subjects treated with hyperbaric oxygen therapy: 14.0 +/- 11.8 mmHg in treated group, 5.0 +/- 5.4 mmHg in nontreated group (P = 0.0002). Multivariate analysis of major amputation on all the considered variables confirmed the protective role of s-HBOT (odds ratio 0.084, P = 0.033, 95% CI 0.008-0.821) and indicated as negative prognostic determinants low ankle-brachial index values (odds ratio 1.715, P = 0.013, 95% CI 1.121-2.626) and high Wagner grade (odds ratio 11.199, P = 0.022, 95% CI 1.406-89.146).

CONCLUSIONS

s-HBOT, in conjunction with an aggressive multidisciplinary therapeutic protocol, is effective in decreasing major amputations in diabetic patients with severe prevalently ischemic foot ulcers.

摘要

目的

评估在综合治疗方案基础上，全身高压氧疗法（s HBOT）对降低因严重足部溃疡住院的糖尿病患者大截肢率的有效性。

研究设计与方法

1993年8月至1995年8月，70例糖尿病足部溃疡患者连续入住我们的糖尿病科。所有患者均接受我们的诊断 - 治疗方案，并随机接受s - HBOT治疗。治疗组和未治疗组各有1例患者未完成治疗方案，因此被排除在结果分析之外。最终，35例患者接受了s - HBOT治疗，另外33例未接受。

结果

治疗组（平均疗程 = 38.8 +/- 8）中，3例患者（8.6%）接受了大截肢：2例膝下截肢，1例膝上截肢。在未治疗组中，11例患者（33.3%）接受了大截肢：7例膝下截肢，4例膝上截肢。差异具有统计学意义（P = 0.016）。治疗组的相对风险为0.26（95% CI 0.08 - 0.84）。高压氧治疗患者足部背侧经皮氧分压显著升高：治疗组为14.0 +/- 11.8 mmHg，未治疗组为5.0 +/- 5.4 mmHg（P = 0.0002）。对所有考虑变量进行的大截肢多因素分析证实了s - HBOT的保护作用（优势比0.084，P = 0.033，95% CI 0.008 - 0.821），并表明低踝肱指数值（优势比1.715，P = 0.013，95% CI 1.121 - 2.626）和高Wagner分级（优势比11.199，P = 0.022，95% CI 1.406 - 89.146）是不良预后决定因素。