(1 国家食品药品监督管理局药品审评中心,北京100038； 2 洛阳市中心医院,洛阳471009)
[摘要] 目前,光敏剂辅助的光动力疗法已在恶性肿瘤和某些皮肤病、老年性视网膜黄斑病、局部细菌感染等良性疾病的治疗中发挥了重要作用,新一代光敏剂的研发已成为人们关注的热点。现结合有关光敏剂和光动力治疗的治疗学特点、当前国内光敏剂申报中存在的问题等,探讨光敏药物研发关键点,以期为国内该类药物安全有效性的综合评价提供参考。
[关键词] 光敏剂;光动力治疗;临床评价
[中图分类号] R914 [文献标识码] A [文章编号] 1003 – 3734 (2008) 07 – 0618 – 04
Therapeutic character istics and clinical evaluation element of the photosen sitive drugs
XIE Song-mei1 , FU Shi-ping2
(1 Center for D rug Evaluation, S tate Food and D rug Adm in istration, B eijing 100038, China;2 Luoyang Centra l Hospital, Luoyang 471009, China)
[ Abstract] Recently, PDT following app lication of photosensitive drugs has p layed an important role in ma-lignant tumors and some innocuousness disease such as some skin diseases, senile macular degeneration and topical bacterial infection. Therefore, the investigators pay more attention to the development of new photosensitive drugs.Based on the therapeutic characteristics of these drugs and the questions in new photosensitive drug app lication in China, in this review we indicated the key points of safety and effectiveness evaluation in the development of the photosensitive drugs.
[ Key words] photosensitive drug; photodynamic therapy; clinical evaluation
