The Drug Induced Liver Injury Network (DILIN): Focus on Herbal and Dietary Supplements

药物性肝损伤网络 (DILIN)：专注于草药和膳食补充剂

• 批准号: 9769675
• 负责人: VICTOR J NAVARRO
• 金额: $ 29.83万
• 依托单位: ALBERT EINSTEIN HEALTHCARE NETWORK
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9769675
• 关键词: Accounting; Acute; Affect; Ancillary Study; Area; Biochemical; Biologic Characteristic; Centers for Disease Control and Prevention (U.S.); Chemicals; Clinical; Collaborations; Consumption; Detection; Disease Outbreaks; Dose; Enrollment; Epigallocatechin Gallate; Etiology; Grant; Health Professional; Hepatotoxicity; Herbal supplement; Histologic; Histology; Histopathology; Icterus; Ingredients and Chemicals; Injury; Internet; Investigation; Knowledge; Label; Liver; Marketing; Medical center; Methods; Mississippi; Natural Products; Nested Case-Control Study; Patients; Pattern; Pharmaceutical Preparations; Pharmacoepidemiology; Population; Procedures; Process; Process Assessment; Protocols documentation; Provider; Public Health; Research; Research Activity; Resources; Safety; Scientist; Severities; System; Time; Toxic effect; Toxicology; United States Food and Drug Administration; United States National Institutes of Health; Universities; Work; adjudicate; adjudication; dietary supplements; drug resource; innovation; insight; liver injury; liver transplantation; pharmacovigilance; prospective; recruit; repository; response to injury; search engine; tool; web site

PROJECT SUMMARY The Einstein Medical Center will continue to recruit cases for the three DILIN protocols; prospective, retrospective, and acute, and to participate in all of its procedures and ancillary studies. At Einstein, we will focus our investigative approach on liver injury from Herbal and Dietary Supplements (HDS). Specifically, our approach will entail expansion of prospective enrollment of DILI cases due to HDS, especially those with early injury, using an innovative marketing method termed Search Engine Optimization, whereby the internet will be exploited as a recruitment tool. We will support ongoing chemical analysis of HDS collected from DILIN enrollees in collaboration with the National Center for Natural Products Research (NCNPR) at the University of Mississippi. In order to more fully characterize liver injury associated with HDS, we will oversee several activities. First, we will participate with Dr. David Kleiner from the NIH in a detailed review of the histopathology associated with liver injury from HDS by informing his review with chemical analysis and detailed clinical information. Second, we will oversee a case-by-case review of previously adjudicated cases, taking into consideration newly available chemical analyses of HDS, proposing adjustment to final causality determinations as appropriate. Third, we will, conduct a nested case/control study to identify those factors associated with use of HDS that affect the odds of developing liver injury. This grant will also explore the toxicity of HDS, focusing on Green Tea Extract, a commonly used ingredient of HDS for which there is significant evidence for toxicity; our findings will provide guidance to scientists, regulators, and consumers on the safe use of this ingredient, and define an approach to further research with other natural product ingredients. Finally, we will reduce the turn-around time for product analysis, thus refining the DILIN causality assessment process by incorporating chemical analysis results into its adjudication process. This quicker turn- around time will also facilitate pharmacovigilance efforts in collaboration with the Food and Drug Administration. We will also collaborate with the CDC to support an eventual early warning system for outbreaks of liver injury due to HDS by providing product and de-identified case information on confirmed cases of liver injury due to HDS; this information will allow the detection of outbreaks of attributable liver injury. To support all of our aims, we will continue to oversee and DILIN HDS repository as a critical resource of the DILIN.

项目摘要 爱因斯坦医学中心将继续为三个DILIN协议招募病例;前瞻性， 回顾性和急性，并参与其所有程序和辅助研究。在爱因斯坦，我们将 将我们的研究方法集中在草药和膳食补充剂（HDS）的肝损伤上。具体来说，我们 这种方法将需要扩大HDS所致DILI病例的前瞻性入组，特别是那些早期 伤害，使用一种创新的营销方法称为搜索引擎优化，从而互联网将 被用作招募的工具我们将支持从DILIN收集的HDS的持续化学分析 在与国家天然产品研究中心（NCNPR）在大学合作的报名者 密西西比。为了更全面地描述与HDS相关的肝损伤，我们将观察几个 活动首先，我们将与美国国立卫生研究院的大卫克莱纳博士一起详细回顾 组织病理学与HDS肝损伤相关，通过告知他的化学分析综述， 详细的临床信息。第二，我们将监督对以前裁定的案件进行逐案审查， 考虑到最新可用的HDS化学分析，建议调整最终因果关系 酌情决定。第三，我们将进行巢式病例/对照研究，以确定这些因素 与使用HDS相关，影响发生肝损伤的几率。这项赠款还将探索 HDS的毒性，重点是绿色茶提取物，HDS的常用成分， 毒性的重要证据;我们的研究结果将为科学家，监管机构和消费者提供指导， 该成分安全使用，并确定了进一步研究其他天然产品的方法 成分.最后，我们将减少产品分析的周转时间，从而细化DILIN因果关系 通过将化学分析结果纳入其裁决过程的评估过程。更快的转弯- 大约在一段时间内，还将与食品和药物管理局合作， 局我们还将与疾病预防控制中心合作，支持最终建立一个早期预警系统， 通过提供产品和已确认的去识别病例信息， HDS导致的肝损伤病例;该信息将允许检测可归因的肝损伤的爆发。 为了支持我们的所有目标，我们将继续监督DILIN HDS存储库，将其作为 迪林。