Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct.
Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct.
复制标题
DOI：
10.2165/00002018-200932010-00005
复制
发表时间：
2009
期刊：
影响因子：
4.2
通讯作者：
DILIN Study Group
中科院分区：
文献类型：
--
作者：
Fontana RJ;Watkins PB;Bonkovsky HL;Chalasani N;Davern T;Serrano J;Rochon J;DILIN Study Group
药物性肝损伤（DILI）是一种罕见的药物不良反应，越来越受到医学界、制药行业、监管机构和公众的重视。药物性肝损伤网络（DILIN）的建立是为了促进对DILI的理解和研究，通过对真正的DILI患者进行前瞻性登记，为未来宿主临床、遗传、环境和免疫危险因素的研究提供支持。DILIN还负责制订标准化的命名法、术语和因果关系评价工具。2004年9月，5个临床站点、一个数据协调中心和国家糖尿病、消化和肾脏疾病研究所的资深科学家发起了DILIN前瞻性研究。符合条件的患者需要在DILI发病6个月内达到最低的实验室或组织学标准，并排除其他竞争性肝损伤原因。一般社区环境中已有HIV、乙型肝炎病毒或丙型肝炎病毒感染和/或肝脏生化基线异常的患者符合入组条件。此外，因草药产品导致肝损伤的受试者也有资格参加。没有DILI的对照患者也将在未来被招募。所有转介的受试者都要接受广泛的实验室、病理和影像学检查。在为期6个月的研究访问中符合预定资格标准的受试者随访2年，以更好地确定慢性DILI的自然史。因果关系评估由三名肝病学家组成的小组确定，他们独立分配因果关系评分，范围从1（明确）到5（不太可能），以及严重程度评分，范围从1（轻度）到5（致命）。在前3年，367名受试者被纳入DILIN前瞻性研究。DILIN是一个多中心研究网络，负责提高我们对美国DILI的病因、风险因素和结果的理解。该网络正在实现每月招收10名患者的目标，并正在开发临床数据和生物样本库，用于未来对DILI发病机制和结果的研究。
Drug-induced liver injury (DILI) is an uncommon adverse drug reaction of increasing importance to the medical community, pharmaceutical industry, regulatory agencies and the general public. The Drug-Induced Liver Injury Network (DILIN) was established to advance understanding and research into DILI by initiating a prospective registry of patients with bona fide DILI for future studies of host clinical, genetic, environmental and immunological risk factors. The DILIN was also charged with developing standardized nomenclature, terminology and causality assessment instruments. Five clinical sites, a data coordinating centre and senior scientists from the National Institute of Diabetes and Digestive and Kidney Diseases initiated the DILIN prospective study in September 2004. Eligible patients are required to meet minimal laboratory or histological criteria within 6 months of DILI onset and have other competing causes of liver injury excluded. Patients in the general community setting with pre-existing HIV, hepatitis B virus or hepatitis C virus infections and/or abnormal baseline liver biochemistries are eligible for enrolment. In addition, subjects with liver injury due to herbal products are eligible to participate. Control patients without DILI are also to be recruited in the future. All referred subjects undergo an extensive review of available laboratory, pathology and imaging studies. Subjects who meet pre-defined eligibility criteria at the 6-month study visit are followed for 2 years to better define the natural history of chronic DILI. Causality assessment is determined by a panel of three hepatologists who independently assign a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal). During the first 3 years, 367 subjects were enrolled into the DILIN prospective study. DILIN is a multicentre research network charged with improving our understanding of the aetiologies, risk factors and outcomes of DILI in the US. The network is meeting the targeted enrolment of ten patients per month and is developing a repository of clinical data and biological samples for future studies of DILI pathogenesis and outcome.
登录
查看更多内容
影响因子：
13.5
作者：
Andrade, RJ;Lucena, MI;Hidalgo, R
通讯作者：
Hidalgo, R
影响因子：
24.5
作者：
Aithal, PG;Day, CP
通讯作者：
Day, CP
影响因子：
13.5
作者：
Björnsson, E;Olsson, R
通讯作者：
Olsson, R
影响因子：
29.4
作者：
Andrade, RJ;Lucena, MI;Martin-Vivaldi, R
通讯作者：
Martin-Vivaldi, R
影响因子：
7.6
作者：
De Valle, M. B.;Klinteberg, V. Av;Bjornsson, E.
通讯作者：
Bjornsson, E.