URSODEOXYCHOLIC ACID (UDCA) IN PRIMARY BILIARY CIRRHOSIS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。原发性胆汁性肝硬变(PBC)是一种慢性淤胆性肝病，常导致肝功能衰竭和死亡。目前还没有被接受的形式的药物治疗这种疾病。有毒胆汁酸的积聚可能会使PBC的肝脏损害永久化。熊去氧胆酸是一种无毒的胆汁酸，洗涤力降低，口服时可用于有利地改变胆汁的成分。研究的目的是1)比较UDCA和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和凝血酶原时间的疗效；2)评估对疲劳和瘙痒等症状的疗效；3)确定对食道静脉曲张、腹水或浮肿和脑病的发展或临床进展的影响；4)确定2年后对组织学变化的影响；5)确定UDCA是否有利于影响存活或是否需要移植；6)进行毒性评估和确定安全性。这项研究已经完成，将不再招募更多的患者。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that frequently leads to liver failure and death. No accepted form of medical therapy currently exists for this disease. Accumulation of toxic bile acids may perpetuate liver damage in PBC. Ursodeoxycholic acid is a non-toxic bile acid with decreased detergent power that can be used to alter the composition of bile favorably when given orally. Study aims are to 1) compare effects of UDCA versus placebo on alkaline phosphatase, aspartate aminotransferase, bilirubin, albumin, immunoglobulin M, and prothrombin 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. This study is complete and no further patients will be enrolled.