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学科主题: 临床医学
题名:
Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study
作者: 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
发表日期: 2011-02-01
DOI: 10.1111/j.1600-0781.2010.00555.x
卷: 27, 期:1, 页:17-23
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Dermatology
研究领域[WOS]: Dermatology
关键词[WOS]: PULSED DYE-LASER ; BIRTHMARKS ; PDT
英文摘要:

Background/purpose

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).

Methods

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.

Results

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.

Conclusion

Hemoporfin-PDT is effective and safe for patients with PWS aged 16-50.

语种: 英语
项目资助者: Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co Ltd
WOS记录号: WOS:000285875000003
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/62090
Appears in Collections:北京大学第一临床医学院_期刊论文

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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

Recommended Citation:
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.
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