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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 在美国，由于使用处方药和非处方药而导致的肝损伤是一个日益频繁和重要的医学、科学和公共卫生问题。 药物性肝损伤（DILI）是美国食品和药物管理局（FDA）不批准、撤回、限制使用和临床监测的最常见原因。 由于存在其他潜在的肝损伤原因，缺乏标准化、客观和可重复的诊断标准，并且需要停药和观察，因此建立 DILI 的诊断是有问题的。 药物性肝损伤 (DILI) 被定义为由药物或化学品引起的急性或慢性肝病，并伴有相关实验室、临床 和病理特征。 DILI 的前瞻性研究很少 提供了有关危险因素、特征概况和可能的肝毒性机制的有意义的数据。 药物性肝损伤网络（DILIN）是 NIH 资助的网络，成立于 2003 年，印第安纳大学医学院是临床中心之一。 当前协议是 DILIN 采取的举措之一。在这项药物和 CAM 引起的肝损伤的多中心纵向研究中，我们希望前瞻性地招募 DILI 患者（以及合适的对照）来进行与 DILI 相关的遗传和非遗传研究。

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.