Review article: Recommendations for detection, assessment and management of suspected drug-induced liver injury during clinical trials in oncology patients
Anna Fettiplace, John Marcinak, Michael Merz, Hui-Talia Zhang, Luciana Kikuchi, Arie Regev, Melissa Palmer, Don Rockey, Robert Fontana, Paul H. Hayashi, Hans L. Tillmann, Adrian M. Di Bisceglie, James H. Lewis
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引用次数: 0
Abstract
Drug-induced liver injury (DILI) is a major concern for oncology drugs in clinical practice and under development. Monitoring cancer patients for hepatotoxicity is challenging as these patients may have abnormal liver tests pre-treatment or on-study for many reasons including liver injury due to past oncology treatments, hepatic metastases, medical co-morbidities such as heart failure, and concomitant medications. At present, there are no regulatory guidelines or position papers that systematically address best practices pertaining to DILI detection, assessment and management in oncology patients.
药物性肝损伤(DILI)是临床实践中和研发中的肿瘤药物的一个主要问题。对癌症患者进行肝毒性监测具有挑战性,因为这些患者在治疗前或研究过程中可能会出现肝功能检测异常,原因有很多,包括既往肿瘤治疗导致的肝损伤、肝转移、心力衰竭等并发症以及同时服用药物。目前,还没有监管指南或立场文件系统地阐述有关肿瘤患者 DILI 检测、评估和管理的最佳实践。
期刊介绍:
Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.