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

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)不批准、停用和限制使用的最常见原因。这项多中心研究的目标是开发一种改进的方法来检测、定义和研究美国的DILI。 服用过药物、非处方药或草药(统称为补充或替代药物-CAM)并在服用相关药物时出现或没有出现肝脏反应的受试者，都是潜在的参与对象。入选的确实出现肝脏反应的患者被称为病例，而没有出现肝脏反应的患者被称为对照组。 病例和对照受试者的参与将从基线访问开始。这次访问将包括病史和人口统计学、药剂史、烟酒使用、症状和生活质量问卷的访谈和填写。血液和尿液样本将被收集，用于未来的研究，包括基因测试。少数病例患者可能需要接受肝脏活检或肝脏超声检查，以明确肝病的诊断或严重程度。所有病例受试者将返回进行为期6个月的随访，其中将收集医学访谈、问卷调查、血液和尿液样本以及肝脏超声。 6个月时有持续肝脏损伤证据的病例受试者将被要求在12个月后和此后每年返回进行后续医学访谈、问卷调查以及尿样和血样采集。对于12个月后有持续性肝损伤证据的受试者，建议进行肝活检。 每年将与病例和对照受试者进行接触，以更新联系信息，并可能邀请受试者参加未来的研究。 ‘

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, and limitation in use by the Food and Drug Administration (FDA). The goal of this multi-center study is to develop an improved means of detecting, defining, and studying DILI in the United States. Subjects who have taken a drug, an over-the-counter (non-prescription) medicine, or an herbal remedy (known collectively as complementary or alternative medicines- CAM) and either did or did not develop a liver reaction while taking the drug in question are potential candidates for participation. Patients enrolled that did suffer a liver reaction are known as cases, and those that did not suffer a liver reaction are known as controls. Participation for both case and control subjects will begin with a baseline visit. This visit will include a medical history and interview and completion of demographic, pharmacy history, alcohol and tobacco use, symptoms, and quality of life questionnaires. Blood and urine samples will be collected for future research studies including genetic testing. A minority of case patients may need to undergo a liver biopsy or liver ultrasound to clarify the diagnosis or severity of liver disease. All case subjects will return for a 6 month follow-up visit wherein a medical interview, questionnaires, and blood and urine samples will be collected as well as a liver ultrasound. Case subjects with evidence of ongoing liver injury at 6 months will be asked to return at 12 months and yearly thereafter for a follow-up medical interview, questionnaires, and urine and blood sample collections. A liver biopsy may be recommended for case subjects with evidence of persistent liver injury at 12 months. Yearly contacts will be made to both case and control subjects to update contact information and to possibly invite subjects to take part in future research studies. '