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常规与日光光动力疗法治疗面部和头皮光化性角化病患者:一项随机、个体内对照分析的 12 个月随访结果。

Conventional vs. daylight photodynamic therapy for patients with actinic keratosis on face and scalp: 12-month follow-up results of a randomized, intra-individual comparative analysis.

机构信息

First Dermatology Department, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Dermatology Department, University Hospital of Crete, Crete, Greece.

出版信息

J Eur Acad Dermatol Venereol. 2018 Apr;32(4):595-600. doi: 10.1111/jdv.14613. Epub 2017 Oct 24.

DOI:10.1111/jdv.14613
PMID:28972663
Abstract

INTRODUCTION

Daylight PDT (DLPDT) is a new PDT procedure. Several trials demonstrate that DLPDT achieves similar response rates with conventional PDT (CPDT) in the treatment of non-hyperkeratotic actinic keratoses (AKs) in a nearly painless way. It seems that DLPDT represents a more convenient and equally effective treatment modality. Data on long-term efficacy of DLPDT are limited.

OBJECTIVE

To compare short- and long-term efficacy, safety and tolerability of DLPDT with that of CPDT in face and scalp AKs.

METHODS

The study, an intra-individual right-left comparison study, was conducted in three centres in North, Center and South Greece. Eligible patients received either DLPDT or CPDT randomly allocated to alternate sides of face or scalp. Patients were evaluated at baseline, 3 and 12 months after treatment. Assessments included lesion response at 3 and 12 months, PDT-associated pain during PDT session, local skin reactions 3 days after treatment as well as patients' preference 3 months after treatment.

RESULTS

A total of 46 patients completed the study. Three months after treatment, the overall lesion complete response rate was 78% for DLPDT and 80.6% for CPDT. At the 12-month follow-up, response rate decreased to 71.8% and 73.7% for DLPDT and CPDT accordingly. Regarding response based on lesion grade, response rates obtained in grade-I lesions were higher with DLPDT, while treatment with CPDT resulted to higher rates of cured grade-II lesions at both follow-up visits. Results were not supported by statistical significance. DLPDT was associated with significantly lower pain and reduced severity of local skin reactions. Patients' preference favoured DLPDT.

CONCLUSIONS

Our study demonstrated that DLPDT is similar to CPDT in terms of long-term efficacy and recurrence rates in the treatment of face and scalp AKs. DLPDT demonstrated a better tolerability profile as it was associated with lower pain and less severe adverse events.

摘要

简介

日光动力疗法(DLPDT)是一种新的 PDT 程序。几项试验表明,在非过度角化性光化性角化病(AK)的治疗中,DLPDT 以几乎无痛的方式实现了与传统 PDT(CPDT)相似的反应率。DLPDT 似乎代表了一种更方便且同样有效的治疗方式。关于 DLPDT 的长期疗效数据有限。

目的

比较 DLPDT 和 CPDT 在面部和头皮 AK 中的短期和长期疗效、安全性和耐受性。

方法

这项研究是一项在希腊北部、中部和南部三个中心进行的个体内左右比较研究。符合条件的患者随机分配接受 DLPDT 或 CPDT,分别在面部或头皮的两侧进行治疗。患者在基线、治疗后 3 个月和 12 个月时进行评估。评估包括治疗后 3 个月和 12 个月时的病变反应、PDT 期间的 PDT 相关疼痛、治疗后 3 天的局部皮肤反应以及治疗后 3 个月时的患者偏好。

结果

共有 46 名患者完成了研究。治疗后 3 个月,DLPDT 的总病变完全缓解率为 78%,CPDT 为 80.6%。在 12 个月的随访中,DLPDT 和 CPDT 的缓解率分别下降至 71.8%和 73.7%。根据病变分级的反应,DLPDT 在 I 级病变中获得的反应率更高,而 CPDT 在两次随访中均导致 II 级病变的治愈率更高。结果没有统计学意义支持。DLPDT 与明显较低的疼痛和减轻的局部皮肤反应严重程度相关。患者偏好 DLPDT。

结论

我们的研究表明,DLPDT 在治疗面部和头皮 AK 方面与 CPDT 的长期疗效和复发率相似。DLPDT 具有更好的耐受性,因为它与较低的疼痛和较轻的不良事件相关。

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