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一项测试光动力疗法(PDT)预防糖尿病患者截肢疗效的临床试验。

A clinical trial testing the efficacy of PDT in preventing amputation in diabetic patients.

作者信息

Tardivo João Paulo, Adami Fernando, Correa João Antonio, Pinhal Maria Aparecida S, Baptista Mauricio S

机构信息

Faculdade de Medicina do ABC, Brazil.

Faculdade de Medicina do ABC, Brazil.

出版信息

Photodiagnosis Photodyn Ther. 2014 Sep;11(3):342-50. doi: 10.1016/j.pdpdt.2014.04.007. Epub 2014 May 9.

DOI:10.1016/j.pdpdt.2014.04.007
PMID:24814697
Abstract

The feet of diabetic patients continue to be an unsolved problem in medicine. Uncontrolled neuropathy, ulceration and infection usually lead to amputation and presently there is no effective and reliable method that can be used to provide an efficient cure. Overall improvement in the salvage strategies, based on comprehensive pre-clinical evaluation, debridement, antibiotic therapy and follow up, has shown improvements in certain hospital settings, but the general picture for patients with diabetic foot is to have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) is a treatment modality that uses light to generate in situ reactive oxygen species, which can cause cell death. PDT can be used to treat several diseases, including foot infections that do not respond well to antibiotic therapy. There are several characteristics of PDT that make it potentially ideal to treat diabetic feet: the photosensitizer is non-toxic in the dark, but after illumination it becomes a very efficient antimicrobial agent with topical use, and it can regenerate small bones, such as the phalanges. However, PDT is still not used in clinical practice to treat diabetic feet. Therefore, we decided to perform a clinical study to prove that PDT is an effective method to avoid amputation of infected diabetic feet. An inexpensive PDT protocol was developed and applied to 18 patients with osteomyelitis, classified as Grade 3 on the Wagner scale. Only one of these patients suffered amputation. At least two of them were cured from resistant bacteria strains without intravenous antibiotic therapy. In the control group of 16 patients, all of them ended up suffering amputation. The rate of amputation in the PDT group was 0.029 times the rate in the control group and the difference is clearly statistically significant (p=0.002).

摘要

糖尿病患者的足部问题在医学上仍然是一个尚未解决的难题。未得到控制的神经病变、溃疡和感染通常会导致截肢,目前尚无有效且可靠的方法能够实现有效治愈。基于全面的临床前评估、清创、抗生素治疗及随访的挽救策略虽有整体改善,在某些医院环境中显示出一定成效,但糖尿病足患者的总体情况仍是会进行某种形式的截肢,尤其是在医疗服务不足的人群中。显然有必要针对这一全球性健康问题开发新的治疗策略。光动力疗法(PDT)是一种利用光原位产生活性氧从而导致细胞死亡的治疗方式。PDT可用于治疗多种疾病,包括对抗生素治疗反应不佳的足部感染。PDT具有几个特性,使其在治疗糖尿病足方面具有潜在的理想性:光敏剂在黑暗中无毒,但光照后成为一种非常有效的局部抗菌剂,并且它可以再生小骨头,如趾骨。然而,PDT在临床实践中仍未用于治疗糖尿病足。因此,我们决定开展一项临床研究,以证明PDT是避免感染性糖尿病足截肢的有效方法。我们制定了一种低成本的PDT方案并应用于18例骨髓炎患者,这些患者在瓦格纳分级中为3级。这些患者中只有1例接受了截肢。其中至少有2例在未进行静脉抗生素治疗的情况下从耐药菌株感染中治愈。在16例患者的对照组中,所有人最终都接受了截肢。PDT组的截肢率是对照组截肢率的0.029倍,差异具有明显的统计学意义(p = 0.002)。

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