USC-UCLA Drug-Induced Liver Injury (DILI) Clinical Center.

项目摘要/摘要 针对RFA-DK-17-509的USC-UCLA药物性肝损伤临床中心(CC)提案 “药物性肝损伤网络(DILIN)临床中心继续存在的有限竞争” 希望继续与其他CCS一起参与，推进科学知识和临床评价 帝力。我们的提案将继续合并洛杉矶县仅有的两所医学院，允许我们 能够唯一地捕获帝力案件并将其登记到由数据监督的网络数据库中 协调中心(DCC)。洛杉矶县(2016)的1010万居民是无与伦比的资源 由美国种族最多元化的人口组成。我们的提案继续利用 南加州大学凯克医学院和加州大学洛杉矶分校大卫·格芬医学院的专业知识和人才。 大量的善意和疾病患者的近距离随访证明了我们的CC 在不同人群中捕获DILIN病例的能力，除DILI外，DILI的病因几乎没有重叠 在我们各自的患者群体中存在HDS。继续实施南加州大学-加州大学洛杉矶分校帝力合作伙伴关系的具体目标 将：1)继续招收代表不足和儿科的高质量真正的DILIN病例 人口，重点是增加急性病例的登记；2)开发一项治疗试验 胆汁淤积性肝损伤；3)开发急性肝细胞损伤的治疗试验；4)继续 支持DILIN开发因果关系评估工具的努力，并为 药物警示协议，针对药物或HDS引起的不良肝损伤。

Project Summary/Abstract The USC-UCLA Drug-Induced Liver Injury Clinical Center (CC) proposal in response to RFA-DK-17-509 “Limited Competition for the Continuation of the Drug Induced Liver Injury Network (DILIN) Clinical Centers” hopes to continue to participate with the other CCs to advance the scientific knowledge and clinical evaluation of DILI. Our proposal will continue to combine the only two medical schools in Los Angeles County allowing us to be able to uniquely capture and enroll DILI cases into the Networks database supervised by the Data Coordinating Center (DCC). The 10.1 M residents of Los Angeles County (2016) are an unmatched resource composed of the most ethnically diverse population in the United States. Our proposal continues to utilize the expertise and talents from Keck School of Medicine of USC and David Geffen School of Medicine at UCLA. The enrollment of a large number of bona fide and ill patients with close follow up has demonstrated our CC’s ability to capture DILIN cases in this diverse populations with little overlap in etiology for DILI other than for HDS in our respective patient populations. The Specific Aims for the continuation of the USC-UCLA DILI CC are to: 1) Continued enrollment of high quality bona fide DILIN case from under represented and Pediatric populations with emphasis on increasing enrollment of acute cases; 2) Development of a treatment trial for cholestatic liver injury; 3) Development of a treatment trial for acute hepatocellular Injury; and 4) Continued support of the DILIN’s effort to develop causality assessment instruments and development of a pilot project for a pharmacovigilance protocol for adverse liver injury due to medication or HDS.