URSODEOXYCHOLIC ACID IN PRIMARY BILIARY CIRRHOSIS

熊去氧胆酸在原发性胆汁性肝硬化中的应用

• 批准号: 6117513
• 负责人: BURTON COMBES
• 金额: $ 3.48万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6117513
• 关键词: albumins; alkaline phosphatase; ascites; aspartate transaminase; biliary tract disorder chemotherapy; bilirubin; clinical research; drug adverse effect; edema; esophageal varices; fatigue; histology; human morbidity; human mortality; human subject; human therapy evaluation; immunoglobulin M; kernicterus; placebos; primary biliary cirrhosis; prothrombin time; pruritis; ursodeoxycholate

Aims are to 1) compare effects of UDCA versus placebo on alkaline phosphatase, aspartate aminotransferase, bilirubin, albumin, immunoglobulin M, and prothrobin time; 2) evaluate effects on symptoms such as fatigue and pruritus; 3) determine effects on development or clinical progression of esophageal varices, ascites or edema, and encephalopathy; 4) determine effects on histologic changes at 2 years; 5) determine whether UDCA favorably affects survival or need for transplantation; 6) assess toxicity & determine safety.

目的是1）比较UDCA与安慰剂对碱性磷酸酶，天冬氨酸氨基转移酶，胆红素，白蛋白，免疫球蛋白M和原蛋白蛋白时间的影响； 2）评估对疲劳和瘙痒等症状的影响； 3）确定对食管静脉曲张，腹水或水肿以及脑病的发育或临床进展的影响； 4）确定对2年的组织学变化的影响； 5）确定UDCA是否有利地影响生存或需要移植； 6）评估毒性并确定安全性。