Hemoporfin Photodynamic Therapy for Port-Wine Stain: A Randomized Controlled Trial.

Autor: Yi Zhao, Ping Tu, Guoyu Zhou, Zhanchao Zhou, Xiaoxi Lin, Huilan Yang, Zhong Lu, Tianwen Gao, Yating Tu, Hongfu Xie, Qingshan Zheng, Ying Gu, Jining Tao, Xuejun Zhu
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: PLoS ONE, Vol 11, Iss 5, p e0156219 (2016)
Druh dokumentu: article
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0156219
Popis: BACKGROUND AND OBJECTIVES:Photodynamic therapy (PDT) has shown potentially beneficial results in treating port-wine stain, but its benefit-risk profile remains undefined. This study aimed to evaluate the efficacy and safety of PDT conducted with hemoporfin and a 532 nm continuous wave laser to treat port-wine stain clinically. PATIENTS AND METHODS:This randomized clinical trial was conducted in eight hospitals in China. Participants were adolescent and adult patients (age range: 14-65 years old) with port-wine stain. During stage 1 (day 1 to week 8) all patients were randomized at a 3:1 ratio to treatment (532 nm laser irradiation (96-120 J/cm2) with hemoporfin (5mg/kg; PDT-hemoporfin, n = 330)) or placebo groups (irradiation with placebo (PDT-placebo, n = 110)); during stage 2 (week 8 to 16) patients in both groups were offered treatment. Clinician-evaluators, who were blind to the study, classified each case on the following four-level scale according to assessment of before and after standardized pictures of the lesion area: no improvement:
Databáze: Directory of Open Access Journals