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一种基于光裂合酶的医疗设备对Ⅲ-Ⅳ型光皮肤患者光化性角化病的影响:真实临床环境

Effect of a Photolyase-Based Medical Device on Actinic Keratosis in Phototypes III-IV Patients: Real-Life Clinical Setting.

作者信息

Bulla Fernando, Mejía Susana, Gil-Quiñones Sebastian, Cataño Sara, Sierra Susana

机构信息

Mohs Surgery, Centro Médico de la Sabana and Hospital Simón Bolivar, Dermatology Department, Universidad El Bosque, Bogotá, Colombia.

Dermatology Department, Clínica Aurora, Carrera 46 #7-12, Patio Bonito, Medellín, Colombia.

出版信息

Dermatol Ther (Heidelb). 2025 Jun 16. doi: 10.1007/s13555-025-01455-6.

Abstract

INTRODUCTION

Actinic keratoses (AK) are premalignant skin lesions that occur in chronically photo-exposed body areas. Topical sunscreens prevent but do not reverse ultraviolet radiation (UVR)-induced damage to deoxyribonucleic acid (DNA). Eryfotona is a sunscreen product that combines high solar protection factors with light-driven DNA repair enzymes known as photolyases. This photolyase-based medical device has been shown to reduce the absolute number of AK; however, a more comprehensive assessment of AK lesions is ideal for determining its actual effect in everyday practice. The purpose of the study is to evaluate the photoprotective effect of Eryfotona sunscreen on individual AK lesions, assessing changes in their clinical and dermoscopic presentation in a real-life clinical setting and the impact on the health-related quality of life.

METHODS

This was an observational, prospective, real-life study of adult patients with skin phototypes III or IV and actinic keratosis (AK) lesions on the face and scalp. Patients were treated with sunscreen containing photolyase twice daily for 6 months, with follow-up visits at 3 and 6 months. The clinical evaluation included the actinic keratosis and severity index (AKASI), the absolute number and individual dimensions of AK lesions, and the Olsen clinical classification scheme. The dermoscopic evaluation included the Zalaudek classification and assessment of lesion pigmentation. The AK Quality of Life (AKQoL) questionnaire was administered to patients during each follow-up. A repeated measures analysis of variance was performed to compare quantitative outcomes, and Fisher's exact tests were used for categorical variables.

RESULTS

A total of 45 patients with 205 AK lesions were included; 25 patients completed both follow-ups. Clinically, there was a significant improvement from an AKASI score of 2.55 at baseline to 1.90 at 6 months (p = 0.000), and a significant difference was also observed in the dimensions of individual AK lesions and the Olsen classification between the three evaluation times (p = 0.000). Dermoscopic assessment, as classified by the Zalaudek classification, showed significant improvement throughout the three evaluations (p = 0.000). In total, 53 lesions disappeared, corresponding to 26.36% of the lesions.

CONCLUSIONS

Eryfotona provided effective and safe photoprotection and treatment of actinic keratosis on the face and scalp in patients with phototypes III and IV in the real-life clinical setting, showing promising effects on higher-grade lesions.

摘要

引言

光化性角化病(AK)是发生在长期暴露于阳光下的身体部位的癌前皮肤病变。外用防晒霜可预防但不能逆转紫外线(UVR)对脱氧核糖核酸(DNA)的损伤。Eryfotona是一种防晒产品,它将高防晒系数与称为光解酶的光驱动DNA修复酶相结合。这种基于光解酶的医疗器械已被证明可减少AK的绝对数量;然而,对AK病变进行更全面的评估对于确定其在日常实践中的实际效果是理想的。本研究的目的是评估Eryfotona防晒霜对单个AK病变的光保护作用,在现实临床环境中评估其临床和皮肤镜表现的变化以及对健康相关生活质量的影响。

方法

这是一项针对面部和头皮患有皮肤光型III或IV且患有光化性角化病(AK)病变的成年患者的观察性、前瞻性、现实生活研究。患者每天两次使用含光解酶的防晒霜治疗6个月,在3个月和6个月时进行随访。临床评估包括光化性角化病和严重程度指数(AKASI)、AK病变的绝对数量和个体尺寸以及奥尔森临床分类方案。皮肤镜评估包括扎劳德克分类和病变色素沉着评估。在每次随访期间向患者发放AK生活质量(AKQoL)问卷。采用重复测量方差分析比较定量结果,采用费舍尔精确检验分析分类变量。

结果

共纳入45例患者,205个AK病变;25例患者完成了两次随访。临床上,AKASI评分从基线时的2.55显著改善至6个月时的1.90(p = 0.000),在三个评估时间点,单个AK病变的尺寸和奥尔森分类也存在显著差异(p = 0.000)。根据扎劳德克分类进行的皮肤镜评估在三次评估中均显示出显著改善(p = 0.000)。共有53个病变消失,占病变总数的26.36%。

结论

在现实临床环境中,Eryfotona为光型III和IV的患者面部和头皮的光化性角化病提供了有效且安全的光保护和治疗,对高级别病变显示出有前景的效果。

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