Clinical effect and safety of magnesium isoglycyrrhizinate in treatment of autoimmune-like drug-induced liver injury

Objective To investigate the clinical effect and safety of magnesium isoglycyrrhizinate in the treatment of autoimmune-like drug-induced liver injury. Methods A total of 53 patients with autoimmune-like drug-induced liver injury who were hospitalized in Beijing YouAn Hospital,Capital Medical University,from July 2016 to January 2019 was enrolled as observation group,and 50 patients with drug-induced liver injury who had no autoimmune symptoms were enrolled as control group. All patients were given magnesium isoglycyrrhizinate( 200 mg/d) for 4 weeks. Liver function and immunological indices were observed before and after treatment,and adverse reactions were recorded for all patients. Liver function was followed up every month for 6 months after treatment. The t-test was used for comparison of normally distributed continuous data between groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the chi-square test or the Fisher's exact test was used for comparison of categorical data between groups.Results After treatment,the observation group had significant reductions in alanine aminotransferase( ALT) [35. 4( 29. 2-42. 0) U/L vs 289. 0( 226. 6-460. 3) U/L,Z =-8.661,P<0. 001],aspartate aminotransferase( AST) [46. 3( 15.6-183.5) U/L vs 306. 3( 32. 2-589. 8) U/L,Z =-5. 271,P < 0. 001],gamma-glutamyl transpeptidase( GGT) [77. 0( 53. 2-183. 2) U/L vs 129. 0( 77. 8-232. 5) U/L,Z =-3. 437,P =0. 001],alkaline phosphatase( ALP) [83. 1( 64. 9-83. 1) U/L vs 119. 4( 104. 9-146. 9) U/L,Z =-3. 485,P < 0. 001],and total bilirubin( TBil)( 27. 5 ±10. 3 μmol/L vs 59. 7 ±18.6 μmol/L,t =6. 673,P <0. 001),and the control group also had significant reductions in ALT[33. 1( 14. 9-106. 4) U/L vs 300. 6( 206. 8-679. 5) U/L,Z =-8. 232,P < 0. 001],AST [44. 1( 20. 8-151. 6) U/L vs 321. 7( 36. 2-553. 2) U/L,Z =-3. 549,P < 0. 001],GGT [82. 7( 50. 6-168. 5) U/L vs 133. 5( 72. 2-254. 2) U/L,Z =-2. 364,P = 0. 018],ALP [87. 6( 74. 3-139. 4) U/L vs 128. 0( 106. 3-201. 4) U/L,Z =-4. 303,P < 0. 001],and TBil( 23. 8 ± 10. 9 μmol/L vs 58. 3 ±19. 8 μmol/L,t =-8. 450,P < 0. 001); however,there were no significant differences between the two groups after treatment( P >0. 05). For the observation group,the level of Ig G decreased from 15. 8 ± 3. 2 g/L before treatment to 14. 2 ± 2. 0 g/L after treatment,and among the 22 patients with elevated Ig G( > 16 g/L) before treatment,18( 81. 8%) had an Ig G level back to normal. Among the 36 patients with positive anti-nuclear antibody,19( 52. 7%) achieved negative conversion. No serious adverse reaction was observed in the two groups. In terms of the patients who underwent liver biopsy,the observation group had a significantly higher proportion of patients with neutrophil and/or eosinophil infiltration than the control group [53. 1%( 17/32) vs 17. 5%( 3/17),χ2= 5. 785,P = 0. 016]. Conclusion Magnesium glycyrrhizinate is safe and effective in the treatment of autoimmune-like drug-induced liver injury and can thus be selected as an alternative treatment method in clinical practice.