Strengthening transformation research and promoting scientific supervision of drug-induced liver injury

Abstract

Drug-induced liver injury (DILI) is the main reason for the failure of new drug research and development before marketing, warning increase post-marketing and withdrawal from the market, which is an important part of drug safety monitoring. It is very important for scientific supervision and clinical practice to pay attention to the liver safety of drugs and carry out corresponding transformation research. The premise of scientific supervision for DILI is to have a comprehensive understanding for its mechanism, risk factors, clinical diagnosis and evaluation, prediction for prognosis, effective interventions and overall assessment for risk/benefit. The mechanism of DILI is related to many links such as drug metabolism, hepatocyte death mechanism, signal transduction pathway, mitochondrial function damage, immune damage, genetic and environmental factors, and etc. For some drugs, combined detection of protein tyrosine phosphatase non-receptor type 22 and human leukocyte antigen is expected to be an important method to screen the high-risk population of DILI. Due to the lack of specific diagnostic markers, the diagnosis of DILI is facing challenges. The complex clinical phenotype of DILI also makes diagnosis more difficult. European and American countries have set up a special cooperative network of DILI, in which DILI patients were prospectively entered for follow-up and biological sample database were established, effectively promoting the research progress in DILI field. The Hepatox network platform (www.hepatox.org) established specially for DILI in China has been launched and more than 30 000 real world databases on DILI patients have been established, which lays a good foundation for subsequent transformation research. Key words: Chemical and drug induced liver injury; Organization and administration; Translational medical research