Hugan tablets for the treatment of RUCAM based drug-induced liver injury: a propensity score matching analysis using a nationwide database.

Abstract

BACKGROUND\nDrug-induced liver injury (DILI) is a major clinical challenge with no specific therapeutic drugs available. It is crucial to develop new agents to improve the clinical outcome of patients with DILI. In this study, we aimed to evaluate the efficacy and safety of Hugan tablets in patients with RUCAM based DILI using a nationwide database.\n\n\nRESEARCH DESIGN AND METHODS\nWe analyzed the clinical data of DILI patients from a nationwide DILI database (www.hepatox.org). Patients who received oral Hugan tablets for DILI were defined as the Hugan group, and those who received no treatment for DILI were defined as the control group. Propensity score matching was performed to compare the normalization of alanine aminotransferase (ALT) levels of the two groups.\n\n\nRESULTS\nThere were 111 cases in the Hugan group and 512 cases in the control group that met the inclusion criteria. One-to-one propensity score matching created 111 matched pairs. ALT normalization rate and aspartate aminotransferase (AST) normalization rate in the Hugan group were significantly higher than those in the control group (50.45% vs. 26.13%, p≤.0002 and 67.57% vs. 41.75%, p≤.0001). There were no differences in the incidence of renal function impairment or blood abnormality between the two groups.\n\n\nCONCLUSIONS\nHugan tablets are safe and effective in DILI treatment. Large-scale randomized controlled studies are needed to explore the effects of Hugan tablets on DILI induced by different offending drugs.