NATURAL HISTORY OF PRIMARY BILIARY CIRRHOSIS AFTER TREATMENT WITH METHOTREXATE

甲氨蝶呤治疗后原发性胆汁性肝硬化的自然病史

• 批准号: 7950859
• 负责人: VELIMIR A LUKETIC
• 金额: $ 6.34万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950859
• 关键词: Adverse effects; Aftercare; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Duct (organ) structure; Funding; Grant; Immune; Immune system; Immunosuppressive Agents; Injury; Institution; Liver; Methotrexate; Natural History; Observational Study; Patients; Pharmaceutical Preparations; Poison; Primary biliary cirrhosis; Research; Research Personnel; Resources; Severities; Source; Tacrolimus; Time; United States National Institutes of Health; Ursodeoxycholic Acid; bile duct; bile salts; dosage; liver transplantation

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. Ursodeoxycholic acid (UDCA) is currently the only approved drug for the treatment of PBC. It has been shown to prolong the time to liver transplant and may prolong survival. UDCA does this by reducing the damaging effects of toxic compounds called bile salts that can build up in the liver when there is damage to the ducts. However, UDCA has no effect on the immune system and thus the immune injury to the bile ducts responsible for the disease. Immunosuppressive medications (drugs that lower the immune system), such as methotrexate and tacrolimus, therefore, have been evaluated in clinical trials as treatment for PBC. Even though such studies have shown these drugs to be safe at the dosages prescribed, their potential long-term side effects are unknown. The purpose of this study is to find out if methotrexate or tacrolimus may cause delayed, previously unrecognized effects, either harmful or beneficial, to patients who participated in clinical trials evaluating these medications in PBC at this institution. Subjects will be seen at 3, 6, or 12 month intervals depending upon the severity. This is an observational study.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 熊去氧胆酸（UDCA）是目前唯一获批用于治疗PBC的药物。 它已被证明可以延长肝移植的时间，并可能延长生存期。 UDCA通过减少称为胆盐的有毒化合物的破坏作用来做到这一点，胆盐可以在管道受损时在肝脏中积聚。 然而，UDCA对免疫系统没有影响，因此对引起疾病的胆管的免疫损伤没有影响。 因此，免疫抑制药物（降低免疫系统的药物），如甲氨蝶呤和他克莫司，已在临床试验中作为PBC的治疗进行了评估。 尽管这些研究表明这些药物在处方剂量下是安全的，但其潜在的长期副作用尚不清楚。 本研究的目的是找出是否甲氨蝶呤或他克莫司可能会导致延迟，以前未认识到的影响，无论是有害的或有益的，参加临床试验，评估这些药物在PBC在该机构的患者。 受试者将在 3、6或12个月间隔，取决于严重程度。 这是一项观察性研究。