Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer - A randomized study
Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer - A randomized study
复制标题
DOI：
10.2337/diacare.19.12.1338
复制
发表时间：
1996-12-01
期刊：
影响因子：
16.2
通讯作者：
Morabito, A
中科院分区：
文献类型：
--
作者：
Faglia, E;Favales, F;Morabito, A
研究设计与方法1993年8月至1995年8月，70例糖尿病足溃疡患者在综合治疗的基础上加用全身高压氧治疗，以降低严重足部溃疡患者的截肢率。所有受试者都接受了我们的诊疗方案，并随机接受S-HBOT治疗。两名受试者，一名在治疗组的手臂上，一名在未治疗组的手臂上，没有完成方案，因此被排除在结果分析之外。结果：在治疗组(平均疗程=38.8+/-8)中，3例(8.6%)患者接受了大腿截肢：2例在膝关节以下，1例在膝关节以上。在未治疗组中，11例(33.3%)患者接受了大腿截肢，其中7例在膝以下，4例在膝以上。差异有统计学意义(P=0.016)。治疗组的相对危险度为0.26(95%可信区间0.08~0.84)。高压氧治疗组足背血氧分压显著升高，治疗组为14.0±11.8 mm Hg，非治疗组为5.0±-5.4 mm Hg(P=0.0002)。对所有考虑的变量进行多因素分析证实了S-HBOT的保护作用(优势比0.084，P=0.033，95%CI 0.008-0.821)，并表明低踝臂指数(优势比1.715，P=0.013，95%CI 1.121-2.626)和高瓦格纳分级(优势比11.199，P=0.022，95%CI 1.406-89.146)是负面预后决定因素。结论S-HBOT结合积极的多学科治疗方案，能有效减少糖尿病合并严重的缺血性足部溃疡患者的主要截肢手术。
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 mas 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.