Mount Sinai Regional Drug Induced Liver Injury Network Site

由NIDDK赞助的药物性肝损伤网络（DILIN）成立于2003年， DILI在不同人口和地理范围内的分布。西奈山一直是一个组成部分， DILIN自2013年以来，帮助网络增加招募，使患者人数超过 预期目前的6个临床站点表现非常好，其中西奈山是领先的 招募地点，特别是急性DILI病例。几个新医院的整合西奈山 卫生系统和肝脏研究所的形成，以组织整个卫生系统的肝病护理， 可能导致西奈山DILIN研究中心的入组人数增加，种族多样性增加。作为 总的来说，DILIN已经做好了实现重要目标的准备：继续招募早期患者， 确定DILI生物标志物的病程;增加前瞻性研究中患者的种族/民族多样性 在城市地区集中招募的队列;沿着招募草药和膳食补充剂（HDS）病例 分析储存库中收集的HDS产品;建立早期检测药物的系统， 与DILI相关的HDS，以协助监管机构;并继续提供准确的临床 通过已发表的文献和对Livertox网站的支持获得DILI的信息。具体目标为 西奈山研究中心如下：1）在当前DILIN前瞻性研究中招募DILI成人和儿童 和回顾性数据库; 2）在疑似DILI病程早期专门招募患者; 3） 用非高加索种族患者丰富当前DILIN前瞻性和回顾性数据库; 4） 评估化疗诱导的肝损伤的血清和遗传生物标志物，并确定褪黑素是否 预处理预防化疗诱导的肝损伤;和5）快速识别新批准的 处方药和新的HDS制剂，导致非预期浓度的DILI病例。

The Drug Induced Liver Injury Network (DILIN), sponsored by NIDDK was established in 2003 to identify cases of DILI across a diverse demographic and geographic spectrum. Mount Sinai has been an integral part of the DILIN since 2013 and helped the network increase recruitment such that patient accrual now exceeds expectations. The current 6 clinical sites have performed very well, with Mount Sinai among the leading enrolling sites, particularly for acute DILI cases. The integration of several new hospitals to the Mount Sinai Health System and formation of a Liver Institute to organize hepatology care across the health system will likely result in an increase in enrollment from the Mount Sinai DILIN site with added ethnic diversity. As a whole, the DILIN is well positioned to embark on important goals: continuing to recruit patients early in the course of illness to identify DILI biomarkers; increase the racial/ethnic diversity of patients in the prospective cohort by focused recruitment in urban areas; enrollment of herbal and dietary supplement (HDS) cases along with analysis of HDS products collected in the repository; setting up systems for early detection of drugs or HDS associated with DILI to assist regulatory authorities; and continuing to provide accurate clinical information about DILI through published literature and support for the Livertox website. The Specific Aims for the Mount Sinai site are as follows: 1) To enroll adults and children with DILI in the current DILIN prospective and retrospective databases; 2) To specifically enroll patients early in the course of suspected DILI; 3) To enrich the current DILIN prospective and retrospective databases with patients of non-Caucasian ethnicity; 4) To evaluate serum and genetic biomarkers for chemotherapy-induced liver injury and determine if melatonin pretreatment prevents chemotherapy-induced liver injury; and 5) To rapidly identify newly approved prescription medications and new HDS formulations that cause unexpected concentrations of DILI cases.