[Efficacy and safety profile of magnesium isoglycyrrhizate in patients with a ≤3 fold- elevation of the upper limit of normal transaminases: a multicenter, real-world retrospective study].

Objective: The clinical efficacy of magnesium isoglycyrrhizinate (MgIG) injection in patients with abnormal transaminase levels ≤3 times the upper limit of normal (ULN) was retrospectively study based on a real-world design. Methods: Data were collected from January 2016 to May 2024 at three research centers (The First Hospital of Hebei Medical University, Shanghai Eastern Hepatobiliary Surgery Hospital, and Nanfang Hospital of Southern Medical University) from patients with abnormal transaminase ≤3 times the ULN and assigned according to the treatment regimen into a monotherapy group (including MgIG and other conventional hepatoprotective drugs) and a control group (no hepatoprotective drugs were used). Baseline matching was performed. Efficacy was evaluated by changes in three biochemical indicator conditions: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBil) after seven days of treatment. The independent samples t-test or Wilcoxon rank-sum test was used to analyze the comparison of continuous data between intergroups. The χ2 test or Fisher's exact test was used to compare inter-group categorical variables. Results: A total of 501 cases were included, with a median age of 60 years. Males accounted for 69.9%. Cancer patients accounted for 72.5%. The baseline matching resulted in a 1∶1 group assignment. The results showed, following seven days of treatment: (1) Magnitude of reduction: ALT and TBil were significantly lower in the other conventional hepatoprotective drug groups than in the control group (P<0.05), while ALT, AST, and TBil were significantly lower in the MgIG group than in the control group (P<0.05). The reduction in ALT and AST was significantly higher in the MgIG group than in the other conventional hepatoprotective drug groups (P<0.05). (2) Normalization rate response: The normalization rate of TBil was lower in other conventional hepatoprotective drug groups than that in the blank group (P<0.05), while the normalization rate of AST was significantly higher in the MgIG group than that in the blank group (P<0.05), and the normalization rates of ALT, AST, and TBil were all significantly higher in the MgIG group than those in other conventional hepatoprotective drug groups (58.7% vs. 40.0%, 74.7% vs. 49.3%, and 66.7% vs. 50.7%, respectively, P<0.05). (3) Proportion of patients with a >50% decrease in the three indicators from baseline: There was no statistically significant difference between the other conventional hepatoprotective drug groups and the control group (P>0.05), while the MgIG group had significantly higher ALT and AST levels than the control group and other conventional hepatoprotective drug groups (ALT: 45.9% vs. 31.1%, 53.3% vs. 38.5%, P<0.05; AST: 50.0% vs. 24.0%, 54.7% vs. 30.0%, P<0.001). (4) Safety profile assessment: There was no statistically significant difference between the MgIG group and other conventional hepatoprotective drug groups (P>0.05). Conclusion: MgIG can rapidly, effectively, and safely improve liver function indicators in patients with abnormal transaminase elevations ≤ 3×ULN.