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使用两种不同光源对光化性角化病进行局部光动力疗法的半脸研究:LED系统的非劣效性

Split-face-study using two different light sources for topical PDT of actinic keratoses:non-inferiority of the LED system.

作者信息

Babilas Philipp, Travnik Richard, Werner Annegret, Landthaler Michael, Szeimies Rolf-Markus

机构信息

Department of Dermatology, University of Regensburg, Germany.

出版信息

J Dtsch Dermatol Ges. 2008 Jan;6(1):25-32. doi: 10.1111/j.1610-0387.2007.06555.x. Epub 2007 Nov 9.

Abstract

BACKGROUND

Photodynamic therapy (PDT) with 5-amino-4-oxo-pentanoate (methylaminolevulinate, MAL) is an effective and safe treatment option for actinic keratoses. Light-emitting diodes (LED) are suitable light sources for topical PDT. To evaluate the efficacy, painfulness, patient satisfaction and cosmesis of LED-based PDT a prospective, randomized and controlled split-face study was performed.

METHODS

Topical ALA-PDT was administered to 17 patients whose actinic ker-atoses (n = 131) were symmetrically distributed and suitable for a two-side comparison. After incubation with MAL (16%), irradiation was performed with the incoherent lamp (160 mW cm(-2); 100 J cm(-2), PDT 1200L, Waldmann Medizintechnik, Villingen-Schwenningen, Germany) on one side and the LED system (120 mW cm(-2); 40 J cm(-2), LEDA, WaveLight AG, Erlangen, Germany) on the other side. The patients were followed by re-evaluation up to 6 months.

RESULTS

Six months following treatment there was no significant difference between the infiltration and keratosis scores in both treatment regimes (p = 0.812). The remission rate was 78.5% (LED system) vs.80.3% (incoherent lamp). There was no significant difference between both light sources regarding the pain during therapy (p = 0.988). There was no significant difference between both treatment regimes regarding patient satisfaction (p = 1).

CONCLUSIONS

LEDA-based MAL-PDT is an effective alternative for the treatment of atinic keratoses. The remission rates and cosmetic results are not inferior to PDT using incoherent light systems. Both treatment regimes are similarly painful.

摘要

背景

5-氨基-4-氧代戊酸(甲基氨基酮戊酸,MAL)光动力疗法(PDT)是治疗光化性角化病的一种有效且安全的治疗选择。发光二极管(LED)是局部PDT合适的光源。为评估基于LED的PDT的疗效、疼痛程度、患者满意度和美容效果,进行了一项前瞻性、随机对照的半脸研究。

方法

对17例光化性角化病(n = 131)对称分布且适合双侧比较的患者进行局部ALA-PDT治疗。用MAL(16%)孵育后,一侧用非相干灯(160 mW/cm²;100 J/cm²,PDT 1200L,德国维林根-施温宁根的Waldmann Medizintechnik公司)照射,另一侧用LED系统(120 mW/cm²;40 J/cm²,LEDA,德国埃尔朗根的WaveLight AG公司)照射。对患者进行随访,重新评估长达6个月。

结果

治疗6个月后,两种治疗方案的浸润和角化评分无显著差异(p = 0.812)。缓解率为78.5%(LED系统)对80.3%(非相干灯)。两种光源在治疗期间的疼痛方面无显著差异(p = 0.988)。两种治疗方案在患者满意度方面无显著差异(p = 1)。

结论

基于LEDA的MAL-PDT是治疗光化性角化病的一种有效替代方法。缓解率和美容效果不低于使用非相干光系统的PDT。两种治疗方案的疼痛程度相似。

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