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麻风病后遗症患者溃疡的临床流行病学评估及低水平激光治疗对伤口愈合的影响:一项随机临床试验。

Clinic-epidemiological evaluation of ulcers in patients with leprosy sequelae and the effect of low level laser therapy on wound healing: a randomized clinical trial.

机构信息

Dermato-Immunology Laboratory UEPA/UFPA/Marcello Candia, Marituba, Pará, Brazil.

出版信息

BMC Infect Dis. 2010 Aug 10;10:237. doi: 10.1186/1471-2334-10-237.

Abstract

BACKGROUND

Mycobacterium leprae is the only pathogenic bacteria able to infect peripheral nerves. Neural impairment results in a set of sensitive, motor and autonomic disturbances, with ulcers originating primarily on the hands and feet. The study objectives were to analyze the clinic-epidemiological characteristics of patients attended at one specialized dressing service from a leprosy-endemic region of the Brazilian Amazon and to evaluate the effect of low level laser therapy (LLLT) on wound healing of these patients.

METHODS

Clinic-epidemiological evaluation of patients with leprosy sequelae was performed at the reference unit in sanitary dermatology of the state of Pará in Brazil. We conducted anamnesis, identification of the regions affected by the lesions and measurement of ulcer depth and surface area. After that, we performed a randomized clinical trial. Fifty-one patients with ulcers related to leprosy were evaluated, twenty-five of them were randomly assigned to a low level laser therapy group or a control group. Patients were treated 3 times per week for 12 weeks. Outcome measures were ulcer surface area, ulcer depth and the pressure ulcer scale for healing score (PUSH).

RESULTS

Ninety-seven ulcers were identified, with a mean (SD) duration of 97.6 (111.7) months, surface area of 7.3 (11.5) cm2, and depth of 6.0 (6.2) mm. Statistical analysis of the data determined that there were no significant differences in the variables analyzed before and after treatment with low level laser therapy.

CONCLUSIONS

Ulcers in patients with leprosy remain a major source of economic and social losses, even many years after they have been cured of M. leprae infection. Our results indicate that it is necessary to develop new and more effective therapeutic tools, as low level laser therapy did not demonstrate any additional benefits to ulcer healing with the parameters used in this study.

TRIAL REGISTRATION

The trial was registered at ClinicalTrials.gov as NCT00860717.

摘要

背景

麻风分枝杆菌是唯一能够感染外周神经的致病菌。神经损伤导致一系列感觉、运动和自主神经障碍,主要发生在手部和脚部的溃疡。本研究的目的是分析巴西亚马逊地区一个麻风流行地区专门的敷料服务中心就诊的患者的临床流行病学特征,并评估低水平激光治疗(LLLT)对这些患者伤口愈合的影响。

方法

在巴西帕拉州卫生皮肤科的参考单位对麻风后遗症患者进行临床流行病学评估。我们进行了病史调查,确定了受病变影响的区域,并测量了溃疡的深度和面积。之后,我们进行了一项随机临床试验。共评估了 51 例与麻风相关的溃疡患者,其中 25 例随机分为低水平激光治疗组或对照组。患者每周接受 3 次治疗,共 12 周。观察指标包括溃疡面积、溃疡深度和压疮愈合评分(PUSH)。

结果

共发现 97 处溃疡,平均(SD)病程为 97.6(111.7)个月,溃疡面积为 7.3(11.5)cm2,深度为 6.0(6.2)mm。数据分析表明,低水平激光治疗前后,各变量均无显著差异。

结论

即使在治愈麻风分枝杆菌感染多年后,麻风患者的溃疡仍然是造成巨大经济和社会损失的主要原因。我们的结果表明,有必要开发新的、更有效的治疗工具,因为低水平激光治疗在本研究中使用的参数下,对溃疡愈合没有显示出任何额外的益处。

试验注册

该试验在 ClinicalTrials.gov 注册,编号为 NCT00860717。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c4f/2928232/e28cd595b2db/1471-2334-10-237-1.jpg

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