Department of Dermatology, University of L'Aquila, L'Aquila, Italy.
Photobiology Unit, Ninewells Hospital & Medical School, University of Dundee, Dundee, UK.
J Eur Acad Dermatol Venereol. 2018 May;32(5):757-762. doi: 10.1111/jdv.14691. Epub 2017 Dec 26.
Guidelines recommend treating actinic keratoses (AKs) as they are recognized as precursors of invasive squamous cell carcinoma.
The objective of this study was to collect real-world clinical data on the use of methyl aminolevulinate daylight photodynamic therapy (MAL DL-PDT) for the treatment of face and scalp AK in Europe.
A prospective, multicenter, non-interventional study was conducted in six European countries in patients receiving a single treatment of MAL DL-PDT for face and/or scalp AK. Patient-reported outcomes were assessed by patient questionnaires at baseline and at 3 months after treatment, efficacy was assessed at 3 months using a 6-point global improvement scale, and adverse events (AE) were recorded at each visit.
Overall, 325 patients were enrolled from 52 investigational centres, 314 of whom attended the 3-month visit. Most patients had multiple lesions (58.4% had >10 lesions) with lesions mainly located on the scalp (60.0%) and/or forehead (54.2%). AKs were predominantly grade I (39.4%) or grade II (33.2%), and 10.5% of patients had grade III lesions. The proportions of patients and physicians that were overall satisfied to very satisfied with the MAL DL-PDT treatment were 80.4% and 90.3%, respectively. The vast majority of patients (90.0%) would consider using MAL DL-PDT again if needed. Physician-assessed efficacy at 3 months was at least much improved in 83.5% of patients, with 45.9% of patients requiring no retreatment. Related AEs were reported in 15% of patients.
Use of MAL DL-PDT for multiple face and/or scalp AKs resulted in high levels of patient and physician satisfaction in clinical practice in Europe, reflecting the good efficacy and high tolerability of this convenient procedure.
指南建议对光化性角化病(AK)进行治疗,因为它们被认为是侵袭性鳞状细胞癌的前体。
本研究旨在收集欧洲使用氨甲环酸光动力疗法(MAL DL-PDT)治疗面部和头皮 AK 的真实临床数据。
在欧洲的六个国家进行了一项前瞻性、多中心、非干预性研究,纳入了接受单次 MAL DL-PDT 治疗面部和/或头皮 AK 的患者。在基线和治疗后 3 个月时,通过患者问卷评估患者报告的结局,在 3 个月时使用 6 分总体改善量表评估疗效,在每次就诊时记录不良事件(AE)。
总体而言,从 52 个研究中心共招募了 325 名患者,其中 314 名患者参加了 3 个月的随访。大多数患者有多个病变(58.4%有>10 个病变),病变主要位于头皮(60.0%)和/或额头(54.2%)。AK 主要为 I 级(39.4%)或 II 级(33.2%),10.5%的患者为 III 级病变。分别有 80.4%和 90.3%的患者和医生对 MAL DL-PDT 治疗总体满意或非常满意。绝大多数患者(90.0%)如果需要,会考虑再次使用 MAL DL-PDT。医生评估的 3 个月疗效在 83.5%的患者中至少明显改善,45.9%的患者无需再次治疗。15%的患者报告了相关 AE。
在欧洲的临床实践中,MAL DL-PDT 治疗多发性面部和/或头皮 AK 可使患者和医生满意度达到较高水平,这反映了该便捷治疗方法的良好疗效和高耐受性。