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

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在美国检测、定义和研究DILI的改进方法。 已服用药物、非处方药（非处方药）或草药（统称为补充或替代药物- CAM）且在服用相关药物期间发生或未发生肝脏反应的受试者是参与研究的潜在候选人。入选的确实发生肝脏反应的患者被称为病例，未发生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视开始开始。此次访视将包括病史和访谈，并完成人口统计学、药房史、酒精和烟草使用、症状和生活质量问卷。将采集血液和尿液样本用于未来的研究，包括基因检测。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脏疾病的诊断或严重程度。所有病例受试者将返回进行6个月随访访视，其中将收集医学访谈、问卷、血液和尿液样本以及肝脏超声。 将要求在6个月时有持续肝损伤证据的病例受试者在12个月时返回，此后每年返回一次，进行随访医学访谈、问卷调查以及尿液和血液样本采集。对于12个月时有持续性肝损伤证据的病例受试者，可建议进行肝活检。 将每年联系病例和对照受试者，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.