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

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。处方药和非处方药引起的肝损伤在美国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)拒绝批准、停用、限制使用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、客观和可重复的诊断标准，以及需要停药和观察，确定DILI的诊断是有问题的。药物性肝损伤(DILI)是指由药物或化学物质引起的一种急慢性肝病，具有相关的实验室、临床和病理特征。很少有关于DILI的前瞻性研究提供了关于危险因素、特征特征和可能的肝毒性机制的有意义的数据。药物诱导肝损伤网络(DILIN)是由美国国立卫生研究院资助的网络，成立于2003年，印第安纳大学医学院是其临床中心之一。DILIN采取的举措之一是目前的议定书。在这项关于药物和CAM诱导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(和合适的对照)进行与DILI相关的遗传学和非遗传学研究。

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 hepatotoxicity. 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.