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: 7606429
• 负责人: NAGA P CHALASANI
• 金额: $ 0.67万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606429
• 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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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性或慢性肝病，与临床、实验室有关。 和病理特征。关于帝力的前瞻性研究很少。 这为肝毒性的危险因素、特征和可能的机制提供了有意义的数据。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。