外用核黄素与5-氨基酮戊酸光动力疗法治疗轻至中度痤疮：一项半脸随机研究。

Topical riboflavin versus 5-aminolevulinic acid photodynamic therapy for the treatment of mild to moderate acne: A split-face randomized study.

作者信息

Ding Aijia, Shi Li, Jiang Feng, Wang Chong, Zhang Jianglin

机构信息

Department of Dermatology, Xiangya Hospital of Central South University, Changsha 410008, Hunan, China; Department of Dermatology, Shenzhen People's Hospital (The Second Clinical Medical College of Jinan University; The First Affiliated Hospital of Southern University of Science and Technology), Shenzhen 518020, Guangdong, China; Candidate Branch of National Clinical Research Center for Skin Diseases, Shenzhen 518020, Guangdong, China.

Department of Dermatology, Shenzhen People's Hospital (The Second Clinical Medical College of Jinan University; The First Affiliated Hospital of Southern University of Science and Technology), Shenzhen 518020, Guangdong, China; Candidate Branch of National Clinical Research Center for Skin Diseases, Shenzhen 518020, Guangdong, China.

出版信息

Photodiagnosis Photodyn Ther. 2025 Feb;51:104449. doi: 10.1016/j.pdpdt.2024.104449. Epub 2024 Dec 19.

DOI:10.1016/j.pdpdt.2024.104449

PMID:39709022

Abstract

BACKGROUND

ALA-PDT has been widely used in mild to moderate acne vulgaris worldwide. However, very few studies used riboflavin-PDT to treat acne vulgaris.

OBJECTIVE

To investigate the efficacy and adverse events of riboflavin-PDT to treat mild to moderate facial acne, and compare it with ALA-PDT on a non-inferiority basis.

METHODS

33 eligible patients were enrolled, and 30 patients completed follow-up. Either side of the face was assigned randomly to riboflavin or ALA blue-light-PDT. Patients received 3 sessions of PDT in 1-week intervals and were followed up at weeks 4, 6, and 10.

RESULTS

Both ALA and riboflavin-PDT significantly reduced non-inflammatory and inflammatory lesions at weeks 4, 6, and 10 compared to baseline (P all <0.001). For the primary outcome, the difference in the improvement rate of total lesions between the Ribo and ALA side was 2.6 % (-4.3 %, 12.5 %; p = 0.71), which didn't reach the inferiority margin. Patients described greater in-treatment pain and burning sensation (P < 0.001), more prominent post-treatment erythema (P = 0.003), hyperpigmentation (P < 0.001), and desquamation (P = 0.006) on the ALA side than on riboflavin side.

CONCLUSION

The efficacy of riboflavin-PDT was comparable to that of blue-light ALA-PDT in treating mild to moderate acne vulgaris. Riboflavin-PDT had fewer in-treatment and post-treatment adverse events than ALA-PDT.

摘要

背景

5-氨基酮戊酸光动力疗法（ALA-PDT）已在全球范围内广泛应用于治疗轻至中度寻常痤疮。然而，很少有研究使用核黄素-PDT治疗寻常痤疮。

目的

探讨核黄素-PDT治疗轻至中度面部痤疮的疗效和不良事件，并在非劣效性基础上与ALA-PDT进行比较。

方法

纳入33例符合条件的患者，30例患者完成随访。将面部的任意一侧随机分配接受核黄素或ALA蓝光-PDT治疗。患者每隔1周接受3次PDT治疗，并在第4、6和10周进行随访。

结果

与基线相比，ALA和核黄素-PDT在第4、6和10周时均显著减少了非炎性和炎性皮损（所有P值均<0.001）。对于主要结局，核黄素组和ALA组之间总皮损改善率之差为2.6%（-4.3%，12.5%；P = 0.71），未达到劣效界值。患者描述ALA组在治疗过程中的疼痛和烧灼感更强（P < 0.001），治疗后红斑更明显（P = 0.003），色素沉着更显著（P < 0.001），脱屑更严重（P = 0.006）。