"Mount Sinai Regional Drug Induced Liver Injury Network Site"

“西奈山地区药物性肝损伤网络网站”

基本信息

批准号：
8920565
负责人：
Jawad Ahmad
金额：
$ 28.71万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-15 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8920565
关键词：
2 year old Acute Liver Failure Adult African American Age Algorithms Ancillary Study Antiviral Agents Area Asians Biological Markers Blood Blood specimen Caring Categories Child Clinical Clinical Data Collaborations Complementary and alternative medicine Computerized Medical Record DNA Data Databases Diagnosis Diagnostic Disease Early Diagnosis Electronics Eligibility Determination Enrollment Ensure Epidemiology Ethnic group Etiology Fatty Liver Frequencies Future General Practitioners Genomics Geriatrics Goals HIV HIV Infections Health Hematologic Neoplasms Hepatic Hepatitis C virus Hepatology Hepatotoxicity Hispanics Home environment Human Resources Immunologic Deficiency Syndromes Individual Informed Consent Infusion procedures Injury Injury to Liver Institutes Institution International Internist Intervention Investigation Lead Legal Guardians Liver diseases Measures Medical center Minority Minority Groups Molecular Monitor Morbidity - disease rate National Institute of Diabetes and Digestive and Kidney Diseases Nature New York Oncologist Outpatients Parents Pathogenesis Patient Monitoring Patients Pharmaceutical Preparations Pilot Projects Population Population Control Preventive Process Provider Qualifying Reading Recording of previous events Recruitment Activity Research Research Infrastructure Research Personnel Resources Rights Risk Factors Sampling Serum Severities Site Source Staging System Techniques Underrepresented Minority United States National Library of Medicine Ursidae Family Writing acute drug induced liver toxicity acute liver injury age group antiretroviral therapy base biobank case control chemotherapy clinical practice design dietary supplements genetic analysis high risk improved innovation insight instrument liver injury meetings member metropolitan mortality older patient patient population personalized medicine prevent programs prospective response screening success tertiary care tool web site

项目摘要

DESCRIPTION (provided by applicant): Hepatotoxicity due to prescription medications and herbal supplements is increasingly recognized as a major cause of morbidity and mortality throughout the developed world. Due to its idiosyncratic nature, variable presentation, and the vast number of potential causative drugs as well as herbal and dietary supplements, drug-induced liver injury (DILI) is often diagnosed late in its course when patients present with severe liver disease. This makes diagnosis and characterization of the mechanisms involved in the pathogenesis of DILI, difficult and does not allow accurate assessment of the epidemiology and risk factors associated with DILI. Since one of the main concerns with the current DILIN is the late presentation of cases, future investigation should focus on accruing cases where the liver injury is detected early on. The aims of the Mount Sinai membership in the NIDDK DILI study are as follows: 1) To rapidly increase the number of enrolled adults and children with DILI, particularly among under-represented minority groups in the current DILIN prospective and retrospective databases; 2) To enroll patients early in the course of DILI by closely monitoring high risk groups; and 3) ultimately to investigate preventative measures to prevent DILI among high risk groups. The inclusion of Mount Sinai in the DILIN will lead to an increase in the number of DILI cases from Hispanic, Black and Asian patients. The significant number of Asian and Hispanic patients who will be recruited from the New York area may provide insights into the mechanism of liver injury related to the use of herbal and dietary supplements as these populations are known to be frequent users of these complementary and alternative medicines. A major component of the Mount Sinai DILIN will be focused on the recruitment of elderly patients with DILI, and importantly also on a control population taking these supplements, a population not well represented to date in the network. Similarly, Mount Sinai's large population of 4,000 HIV infected patients will provide cases and controls to represent the large population on antiretroviral therapy. The large number of patients undergoing chemotherapy treatment followed by the many Mount Sinai oncologists represents another ideal source of prospective DILI cases and controls. Mount Sinai is a member of eMERGE, a national consortium to develop, disseminate, and apply approaches using electronic medical records (EMR) systems to genomics research. A current projects in eMERGE is to develop an electronic algorithm to identify cases of DILI in EMR systems. If just 1 percent of the 100,000 eMERGE DNA samples have a history of DILI, then the DILIN could double its DNA sample database overnight. Investigators at Mount Sinai are well-qualified and poised to contribute to ancillary studies that arise from the wealth of available data and samples of the collective DILIN. Combined with outstanding infrastructure to collect detailed information through exploitation of the EMR and Data Warehouse, the partnership of the Personalized Medicine program, and involvement of a multi-disciplinary team across the institution and its affiliates, we bring tremendous manpower to bear upon this urgent problem.

描述（由申请人提供）：处方药和草药补充剂引起的肝毒性越来越被认为是发达国家发病和死亡的主要原因。由于药物性肝损伤 (DILI) 的特殊性、多变的表现以及大量潜在的致病药物以及草药和膳食补充剂，药物性肝损伤 (DILI) 通常在患者出现严重症状时在病程晚期才被诊断出来。肝脏疾病。这使得 DILI 发病机制的诊断和表征变得困难，并且无法准确评估与 DILI 相关的流行病学和危险因素。由于当前 DILIN 的主要问题之一是病例的迟到，因此未来的调查应重点关注早期发现肝损伤的病例。西奈山会员加入 NIDDK DILI 研究的目的如下： 1) 迅速增加 DILI 成人和儿童的登记人数，特别是当前 DILIN 前瞻性和回顾性数据库中代表性不足的少数群体； 2) 通过密切监测高危人群，在 DILI 病程早期招募患者； 3) 最终研究预防高危人群发生 DILI 的预防措施。将西奈山纳入 DILIN 将导致西班牙裔、黑人和亚洲患者的 DILI 病例数量增加。将从纽约地区招募的大量亚洲和西班牙裔患者可能会深入了解与使用草药和膳食补充剂相关的肝损伤机制，因为这些人群经常使用这些补充和替代药物。西奈山 DILIN 的一个主要组成部分将侧重于招募患有 DILI 的老年患者，重要的是还关注服用这些补充剂的对照人群，该人群迄今为止在网络中没有得到很好的代表。同样，西奈山的 4,000 名 HIV 感染患者将提供病例和对照，以代表接受抗逆转录病毒治疗的大量人群。许多西奈山肿瘤学家随后接受化疗的大量患者代表了前瞻性 DILI 病例和对照的另一个理想来源。西奈山是 eMERGE 的成员，eMERGE 是一个国家联盟，致力于开发、传播和应用使用电子病历 (EMR) 系统进行基因组学研究的方法。 eMERGE 当前的一个项目是开发一种电子算法来识别 EMR 系统中的 DILI 病例。如果 100,000 个 eMERGE DNA 样本中只有 1% 有 DILI 历史，那么 DILIN 的 DNA 样本数据库可以在一夜之间翻倍。西奈山的研究人员资质良好，准备为来自 DILIN 集体的大量可用数据和样本的辅助研究做出贡献。结合出色的基础设施，通过利用电子病历和数据仓库收集详细信息，个性化医疗计划的合作伙伴关系，以及整个机构及其附属机构的多学科团队的参与，我们投入了大量的人力来解决这一紧迫的问题。