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实时温度反馈激光治疗真菌性甲癣的前瞻性疗效和安全性评估

Prospective efficacy and safety evaluation of laser treatments with real-time temperature feedback for fungal onychomycosis.

作者信息

Waibel Jill, Wulkan Adam Jared, Rudnick Ashley

出版信息

J Drugs Dermatol. 2013 Nov;12(11):1237-42.

PMID:24196331
Abstract

BACKGROUND AND OBJECTIVES

Onychomycosis affects five percent of the worldwide population. Onychomycosis is a therapeutic challenge. Current therapies on the market are either ineffective or require patient monitoring. Laser and light technologies are being investigated as a possible treatment option for onychomycosis. The proposed mechanism of action is unknown. All infectious agents may be killed by heat (except prions). One possible theory is the photothermal effect from water absorbing lasers creates bulk heating in the nail plate to kill fungal hyphae. Laser technology may be a promising new treatment option for onychomycosis. This is a prospective trial with real-time temperature feedback to evaluate efficacy and safety of laser therapy for onychomycosis.

METHODS

Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used were 1319 nm, 1064 nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions. Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post treatment. Patients also were asked a pain score from 1-10 during treatment.

RESULTS

Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative for fungal organisms.

CONCLUSION

Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results.

摘要

背景与目的

甲癣影响全球5%的人口。甲癣是一个治疗难题。目前市面上的治疗方法要么无效,要么需要对患者进行监测。激光和光技术正在作为甲癣的一种可能治疗选择进行研究。其作用机制尚不清楚。所有感染因子(朊病毒除外)都可被热杀死。一种可能的理论是,水吸收激光产生的光热效应在甲板中产生大量热量以杀死真菌菌丝。激光技术可能是一种有前景的甲癣新治疗选择。这是一项具有实时温度反馈的前瞻性试验,旨在评估激光治疗甲癣的疗效和安全性。

方法

对21例经病理检查或培养证实为真菌性甲癣的患者进行前瞻性激光治疗,利用实时红外温度反馈使目标温度达到46 - 48摄氏度。所使用的激光和光疗法包括1319纳米、1064纳米和宽谱光。排除标准包括混合感染以及之前未进行过其他治疗干预。受试者每隔一周接受4次治疗。评估包括治疗后1个月、3个月和6个月时的病理检查及培养。还要求患者在治疗期间对疼痛进行1 - 10分的评分。

结果

患者对治疗过程耐受性良好,满意度高。平均治疗时间为10分钟。未观察到不良事件。患者报告治疗期间有轻度至中度短暂不适。6个月的培养结果显示21例中有20例真菌检测为阴性。

结论

激光治疗为甲癣提供了一种安全有效的新选择。对于需要替代或辅助当前治疗方法的庞大市场而言,这可能是最佳治疗方法。激光治疗快速、无痛,无需任何口服药物或血液检测进行监测。需要更多大规模科学研究来证实我们的初步研究结果。

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