[1]Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China.
[2]Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China.
[3]Department of Oral Maxillofacial Surgery, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
[4]Department of Dermatology, The General Hospital of Guangzhou Military Command, Guangzhou, China.
[5]Center for Drug Clinical Research, Shanghai University of Chinese Traditional Medicine, Shanghai, China.
[6]Department of Laser Medicine, Chinese PLA General Hospital, Beijing, China.
[7]Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd, Shanghai, China.
Previous studies have shown that hemoporfin-mediated photodynamic therapy (PDT) was a treatment for port-wine stain (PWS). Our current study aimed to identify optimal hemoporfin dose.;A prospective, multicenter, double-blind, randomized clinical trial was conducted. Patients were assigned into low- or high-dose hemoporfin (2.5 mg/kg and 5 mg/kg intravenously, respectively), or control (placebo) group, at a rate of 2:2:1. Treatment efficacy was evaluated at week 8. Then, patients in control group were randomly assigned into either high- or low-dose hemoporfin group. Treatment reactions and adverse events were analyzed at week 16.;A total of 100 patients (40, 40, 20 in low-, high-dose hemoporfin, and control group, respectively) were enrolled. Compared to low dose (40%) and control group (15%), a higher proportion of patients in high-dose group (75%) had achieved skin lesion improvements. Treatment satisfactions were graded highest in high-dose group. Compared to low-dose group (14.3%), high-dose group (46.0%) had more frequent skin hyperpigmentation, which disappeared 3-6 months after treatment. Other treatment reactions and adverse events were comparable between two groups.;Photodynamic therapy with 5 mg/kg hemoporfin could be an effective and safe treatment for PWS.;
(8.0+极速模式)