An analysis of silybin meglumine tablets in the treatment of drug-induced liver injury as assessed for causality with the updated Roussel Uclaf Causality Assessment Method using a nationwide database.

ABSTRACT

AIM: Drug-induced liver injury (DILI) poses significant challenges to clinical practice. Currently, there is no recommended therapy to treat DILI; therefore, it is vital to explore new therapeutic agents. This study aimed to investigate the efficacy and safety of silybin meglumine tablets in treating DILI. METHODS: This study analysed 34 296 DILI cases assessed by the updated RUCAM from a nationwide database. A total of 301 patients with RUCAM scores ≥6 were directly enrolled in this study, while an additional 340 patients with RUCAM scores <6 who were adjudged as probable DILI by a panel of three hepatologists were also included in the analysis. The enrolled patients were divided into the silybin meglumine group and the control group. The propensity score matching (PSM) method was used to obtain comparable characteristics between the two groups. RESULTS: There were 129 cases in the silybin meglumine group and 512 cases in the control group. After applying PSM, 129 matched pairs were obtained. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) resumption rates in the silybin meglumine group were significantly higher than the control group (58.91% vs. 20.93%, P ≤ .0001 and 63.49% vs. 37.50%, P ≤ .0001). The univariate and multivariate logistic regression analysis revealed that grouping factor (odds raio [OR], 5.42; 95% confidenxe interval [CI], 3.12-9.39; P < .0001 and OR, 6.10; 95% CI, 2.98-12.48; P < .0001) and ALT levels (OR, 0.95; 95% CI, 0.93-0.98; P = .0015 and OR, 0.95; 95% CI, 0.92-0.99; P = .0157) were essential influencing factors for ALT normalization. CONCLUSIONS: Silybin meglumine tablets are safe and effective in DILI treatment. Large-scale and randomized controlled trials are required to further confirm their efficacy.