SAFETY AND EFFICACY OF IV LIPO PGE1 THERAPY IN PATIENTS WITH ISCHEMIC ULCERS

IV LIPO PGE1 治疗缺血性溃疡患者的安全性和有效性

• 批准号: 3742363
• 负责人: JOHN M. PORTER
• 金额: --
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3742363
• 关键词: clinical trials; dosage forms; drug screening /evaluation; human subject; prostaglandin E; ulcer

Prostaglandin E1 in the cyclodextrin conjugate form (PGE1-CD) has been used in the treatment of peripheral arterial occlusive disease (PAOD). Because of the high rate of first pass metabolism in the lungs, PGE1 with lipid encapsulation (lipo-PGE1) can avoid this sequela. A double-blind, randomized, parallel, placebo-controlled group, dose response study to evaluate the safety and efficacy of IV lipo-PGE1 therapy in patients with ischemic ulcers is proposed.

环糊精结合物形式的前列腺素E1（PGE 1-CD）已被 用于治疗外周动脉闭塞性疾病（PAOD）。 由于肺中的首过代谢率高， 脂质包封（lipo-PGE 1）可以避免这种后遗症。 双盲， 随机、平行、安慰剂对照组、剂量反应研究， 评估IV Lipo-PGE 1治疗的安全性和有效性， 提出了缺血性溃疡。