Berendt A R
Bone Infection Unit, Nuffield Orthopaedic Centre NHS Trust, Headington, Oxford, OX3 7LD, United Kingdom.
Clin Infect Dis. 2006 Jul 15;43(2):193-8. doi: 10.1086/505223. Epub 2006 Jun 12.
Diabetic foot ulceration is common, affecting 1.0%-4.1% of diabetic persons per year and up to 25% in a lifetime. Diabetic foot ulcers are multifactorial in origin, and many are slow to heal and/or are complicated by infection, frequently leading to amputation. Hyperbaric oxygen therapy has been suggested for numerous indications, and it is recognized by funding agencies for a smaller number including diabetic foot wounds.
I reviewed the literature about the history and practice of hyperbaric oxygen therapy and key issues relevant to efficacy, effectiveness, and cost-effectiveness.
Although recognized for reimbursement by Medicare and major insurers, the evidence base for hyperbaric oxygen therapy for diabetic foot care remains weak. A systematic review for the Cochrane Collaboration concluded that hyperbaric oxygen therapy may have value in treating diabetic wounds, but the studies reviewed all had methodological weaknesses, and the positive effect of treatment was not seen in the single reviewed randomized trial to include a sham treatment arm. Hyperbaric oxygen therapy consumes very substantial resources--and has the potential to consume far more--that could be better spent on other aspects of management or prevention of diabetic foot ulceration.
Hyperbaric oxygen therapy should not be offered for diabetic foot wounds until large-scale, adequately blinded, controlled, and powered randomized studies have clearly demonstrated efficacy and cost effectiveness in the healing of ulcers and the prevention of major amputation.
糖尿病足溃疡很常见,每年影响1.0%-4.1%的糖尿病患者,一生中患病率高达25%。糖尿病足溃疡病因多方面,许多愈合缓慢和/或并发感染,常导致截肢。高压氧疗法已被用于多种适应症,少数适应症包括糖尿病足伤口得到了资助机构的认可。
我查阅了有关高压氧疗法的历史和实践以及与疗效、有效性和成本效益相关的关键问题的文献。
尽管医疗保险和主要保险公司认可其报销,但糖尿病足护理的高压氧疗法的证据基础仍然薄弱。Cochrane协作网的一项系统评价得出结论,高压氧疗法可能对治疗糖尿病伤口有价值,但所审查的研究都存在方法学缺陷,且在唯一一项纳入假治疗组的随机试验中未观察到治疗的积极效果。高压氧疗法消耗大量资源,而且有可能消耗更多资源,这些资源可更好地用于糖尿病足溃疡管理或预防的其他方面。
在大规模、充分设盲、对照且有足够效力的随机研究明确证明其在溃疡愈合和预防大截肢方面的疗效和成本效益之前,不应将高压氧疗法用于糖尿病足伤口。