|Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study|
|Zhao, Yi1; Zhou, Zhanchao2,3; Zhou, Guoyu4; Tu, Ping1; Zheng, Qingshan5; Tao, Jining6; Gu, Ying7; Zhu, Xuejun1|
|关键词||hematoporphyrin monomethyl ether hemoporfin HMME photochemotherapy photodynamic therapy port-wine stain|
|刊名||PHOTODERMATOLOGY PHOTOIMMUNOLOGY & PHOTOMEDICINE|
|WOS标题词||Science & Technology|
|关键词[WOS]||PULSED DYE-LASER ; BIRTHMARKS ; PDT|
This phase IIa study aimed to study the efficacy and safety of hemoporfin in photodynamic therapy (PDT) with a 532 nm continuous laser for port-wine stain (PWS).
In this 8-week open-labeled study in three centers, three different laser exposure times (532 nm continuous laser for 20, 30 and 40 min) were used in stage I, group A, stage II, group B and stage III, group C, respectively. Primary efficacy assessment was performed by an independent group of experts, who reviewed the standardized photos. Secondary efficacy assessment consisted of the subjective grading of the PWS fading by the investigators and the patients. Treatment reactions and adverse events (AE) were recorded separately.
Forty patients were initially enrolled in the study, but stage III had to be cancelled eventually for the safety of the patients. Patients in groups A and B showed similar satisfactory results in efficacy assessments, the total ′response′ rate being 80.0% and 94.7% in groups A and B, respectively. The AE rates were also similar in the two groups. Self-limiting photosensitive dermatitis and hyperpigmentation were the most frequently observed AE.
Hemoporfin-PDT is effective and safe for patients with PWS aged 16-50.
|资助机构||Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co Ltd|
|作者单位||1.Peking Univ, Hosp 1, Dept Dermatol & Venereol, Beijing 100034, Peoples R China|
2.Chinese Acad Med Sci, Inst Dermatol, Nanjing, Peoples R China
3.Peking Union Med Coll, Nanjing, Peoples R China
4.Shanghai Jiao Tong Univ, Sch Med, Peoples Hosp 9, Dept Oral Maxillofacial Surg, Shanghai 200030, Peoples R China
5.Shanghai Univ, TCM, Ctr Drug Clin Res, Shanghai, Peoples R China
6.Shanghai Fudan Zhangjiang Biopharmaceut Co Ltd, Shanghai, Peoples R China
7.Chinese Peoples Liberat Army Gen Hosp, Dept Laser Med, Beijing, Peoples R China
|Zhao, Yi,Zhou, Zhanchao,Zhou, Guoyu,et al. Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study[J]. PHOTODERMATOLOGY PHOTOIMMUNOLOGY & PHOTOMEDICINE,2011,27(1):17-23.|
|APA||Zhao, Yi.,Zhou, Zhanchao.,Zhou, Guoyu.,Tu, Ping.,Zheng, Qingshan.,...&Zhu, Xuejun.(2011).Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study.PHOTODERMATOLOGY PHOTOIMMUNOLOGY & PHOTOMEDICINE,27(1),17-23.|
|MLA||Zhao, Yi,et al."Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study".PHOTODERMATOLOGY PHOTOIMMUNOLOGY & PHOTOMEDICINE 27.1(2011):17-23.|