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: 7603771
• 负责人: ROBERT J FONTANA
• 金额: $ 1.29万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603771
• 关键词: Alcohols; Alternative Medicine; Blood; Blood specimen; Computer Retrieval of Information on Scientific Projects Database; Diagnosis; Enrollment; Frequencies; Funding; Future; Genetic screening method; Goals; Grant; Injury; Institution; Interview; Liver; Liver diseases; Longitudinal Studies; Medical; Medical History; Medicine; Minority; Non-Prescription Drugs; Patients; Pharmaceutical Preparations; Pharmacy facility; Public Health; Quality of life; Questionnaires; Reaction; Recording of previous events; Research; Research Personnel; Resources; Sampling; Severities; Source; Symptoms; Tobacco use; Ultrasonography; United States; United States Food and Drug Administration; United States National Institutes of Health; Update; Urine; Visit; Withdrawal; case control; follow-up; improved; liver biopsy; prescription document; prescription procedure; research study; sample collection

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. '

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 在美国，因使用处方药和非处方药而导致的肝损伤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、撤回和限制使用的最常见原因。 这项多中心研究的目标是在美国开发一种改进的检测、定义和研究 DILI 的方法。 服用过药物、非处方药或草药（统称为补充或替代药物 - CAM）并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潜在的参与候选人。纳入的确实发生肝脏反应的患者称为病例，而未发生肝脏反应的患者称为对照。 病例和对照受试者的参与将从基线访视开始。这次访问将包括病史和访谈，以及完成人口统计、药房史、酒精和烟草使用、症状和生活质量调查问卷。将收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进行肝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 6 个月的随访，其中将收集医学访谈、问卷、血液和尿液样本以及肝脏超声检查。 6 个月时有持续肝损伤证据的病例受试者将被要求在 12 个月时以及此后每年返回进行后续医疗访谈、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，可能会建议进行肝活检。 每年都会与病例和对照受试者进行联系，以更新联系信息，并可能邀请受试者参加未来的研究。 '