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在 6 个欧洲国家进行的一项关于甲氨基酮戊酸光动力疗法治疗面部和头皮多发性光化性角化病的观察性研究中,患者和医生的满意度。

Patient and physician satisfaction in an observational study with methyl aminolevulinate daylight photodynamic therapy in the treatment of multiple actinic keratoses of the face and scalp in six European countries.

机构信息

Department of Dermatology, University of L'Aquila, L'Aquila, Italy.

Photobiology Unit, Ninewells Hospital & Medical School, University of Dundee, Dundee, UK.

出版信息

J Eur Acad Dermatol Venereol. 2018 May;32(5):757-762. doi: 10.1111/jdv.14691. Epub 2017 Dec 26.

DOI:10.1111/jdv.14691
PMID:29136306
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6084323/
Abstract

BACKGROUND

Guidelines recommend treating actinic keratoses (AKs) as they are recognized as precursors of invasive squamous cell carcinoma.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

背景

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。

目的

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。

方法

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)。

结果

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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/646ad07630be/JDV-32-757-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/0d2e7b8ff429/JDV-32-757-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/801e051c6d48/JDV-32-757-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/e01ac8e80505/JDV-32-757-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/646ad07630be/JDV-32-757-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/0d2e7b8ff429/JDV-32-757-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/801e051c6d48/JDV-32-757-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/e01ac8e80505/JDV-32-757-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a83f/6084323/646ad07630be/JDV-32-757-g004.jpg

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Dermatol Ther (Heidelb). 2017 Dec;7(4):525-533. doi: 10.1007/s13555-017-0199-9. Epub 2017 Sep 13.
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Structured Expert Consensus on Actinic Keratosis: Treatment Algorithm Focusing on Daylight PDT.光化性角化病结构化专家共识:聚焦日光光动力疗法的治疗方案
J Cutan Med Surg. 2017 May/Jun;21(1_suppl):3S-16S. doi: 10.1177/1203475417702994. Epub 2017 Apr 13.
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光动力疗法治疗光化性角化病的研究综述:超越数据和指南建议的更广阔临床视角
Dermatol Ther (Heidelb). 2023 Jul;13(7):1409-1421. doi: 10.1007/s13555-023-00936-w. Epub 2023 Jun 10.
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Use of Lesion Response Rate in Actinic Keratosis Trials.
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7
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J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2342-8. doi: 10.1111/jdv.13228. Epub 2015 Oct 5.
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Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version.基于证据和共识的(S3)光化性角化病治疗指南 - 国际皮肤科学会联盟与欧洲皮肤病学会联盟合作 - 简版。
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