A MULTI-CENTER, LONGITUDINAL STUDY OF DRUG- AND CAM-INDUCED LIVER INJURY

药物和凸轮引起的肝损伤的多中心纵向研究

• 批准号: 7717526
• 负责人: NAGA P CHALASANI
• 金额: $ 0.06万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717526
• 关键词: Acute; Characteristics; Chronic; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data; Development; Diagnosis; Diagnostic; Drug or Chemical; Enrollment; Frequencies; Funding; Genetic; Genetic Research; Grant; Hepatotoxicity; Indiana; Injury; Institution; Laboratories; Liver; Liver diseases; Longitudinal Studies; Medical; Monitor; Patients; Pharmaceutical Preparations; Prospective Studies; Protocols documentation; Public Health; Research; Research Personnel; Resources; Risk Factors; Source; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; Withdrawal; medical schools; prescription document; prescription procedure

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. Liver injury due to prescription and non-prescription medication use is a medical, scientific, and public health problem of increasing frequency and importance in the United States. Drug-induced liver injury (DILI) is the most common reason for non-approval, withdrawal, limitation in use, and clinical monitoring by the Food and Drug Administration (FDA). Establishing a diagnosis of DILI is problematic due to the presence of other potential causes of liver injury, a lack of standardized, objective and reproducible diagnostic criteria, and the need for drug discontinuation and observation. Drug-induced liver injury (DILI) is defined as the development of an acute or chronic liver disease from a drug or chemical with associated laboratory, clinical and pathological features. There have been few prospective studies of DILI that have provided meaningful data on risk factors, characteristics profiles, and possible mechanisms of hepatoxicity. The Drug-Induced Liver Injury Network (DILIN) is a NIH funded network that was established in 2003, and Indiana University School of Medicine is one of the clinical centers. One of the initiatives undertaken by the DILIN is the current protocol. In this multicenter, longitudinal study of drug and CAM-induced liver injury, we would like to prospectively enroll patients with DILI (and suitable controls) for conducting genetic and non-genetic research related to DILI.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 由于处方和非处方药的使用而导致的肝损伤是美国的医学，科学和公共卫生问题，即在美国的频率和重要性增加。 药物诱导的肝损伤（DILI）是食品和药物管理局（FDA）未批准，戒断，使用限制和临床监测的最常见原因。 由于存在肝损伤的其他潜在原因，缺乏标准化，客观和可重现的诊断标准以及对药物终止和观察的需求，因此建立DILI的诊断是有问题的。 药物诱导的肝损伤（DILI）定义为与与相关实验室的药物或化学物质的急性或慢性肝病的发展 和病理特征。 关于DILI的前瞻性研究很少 提供了有关风险因素，特征概况和肝毒性机制的有意义数据。 药物诱导的肝损伤网络（DILIN）是建立于2003年的NIH资助网络，印第安纳大学医学院是临床中心之一。 迪林（Dilin）采取的倡议之一是当前协议。在这项对药物和CAM诱导的肝损伤的多中心纵向研究中，我们希望将DILI（和合适的对照组）的患者前瞻性地招募，以进行与DILI相关的遗传和非遗传研究。