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: 7379134
• 负责人: NAGA P CHALASANI
• 金额: $ 0.75万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379134
• 关键词: MULTI; CENTER; LONGITUDINAL; STUDY; DRUG

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。由于处方和非处方药物使用导致的肝损伤是美国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）是美国食品药品监督管理局（FDA）未批准、撤回、限制使用和临床监测的最常见原因。 由于存在其他肝损伤的潜在原因，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，因此建立DILI的诊断是有问题的。药物性肝损伤（DILI）定义为药物或化学品导致的急性或慢性肝病，具有相关的实验室、临床和病理学特征。很少有DILI的前瞻性研究提供了有关风险因素、特征和肝毒性可能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，印第安纳州大学医学院是临床中心之一。DILIN采取的举措之一是目前的协议。在这项药物和CAM诱导的肝损伤的多中心纵向研究中，我们希望前瞻性招募DILI患者（和合适的对照组），以进行DILI相关的遗传和非遗传研究。