To explore clinical efficacy of modified Sini Decoction combined with magnesium isoglycyrrhizinate in the treatment of patients with drug-induced liver injury, and its effects on liver function, Nrf2 antioxidant and inflammatory reaction indexes of the patients, so as to provide new ideas for the formulation of treatment plan for patients with drug-induced liver injury.Methods:A total of 116 patients with drug-induced liver injury admitted to Xi'an Lintong District Hospital of Traditional Chinese Medicine from January 2016 to October 2018 were selected as the study subjects.According to the number of diagnosis time, they were divided into control group and observation group by random number table method, with 58 cases in each group.Both groups stopped taking suspect drugs, and they were treated with basic hepatoprotective drugs and magnesium isoglycyrrhizinate.The observation group was treated with modified Sini Decoction combined with magnesium isoglycyrrhizinate on the basis of the treatment measures in the control group.The 2 groups of patients were observed for 4 weeks.Scores of clinical symptoms(distending pain in hepatic region, fatigue, loss of appetite, aversion to greasy food, epigastric discomfort and skin yellowing), liver function indexes(ALT, AST, TBIL and AKP), Nrf2 antioxidant indexes(Nrf2, NQO1, HO1, GSH-Px and CAT), inflammatory reaction indexes(TNF-α, NO and IL-10)were evaluated and compared before and after the treatment, and compared between the 2 groups.After the completion of the treatment cycle, the patients were evaluated for clinical efficacy and compared between the 2 groups.Rates of adverse drug reactions(ADRs)in the course of treatment were collected and compared between the 2 groups.Results:1)After the treatment, the scores of clinical symptoms of distending pain in hepatic region, fatigue, loss of appetite, aversion to greasy food, epigastric discomfort and skin yellowing in both groups were lower than those before the treatment, and the scores of distending pain in hepatic region, fatigue, loss of appetite and epigastric discomfort in the observation group were lower than those in the control group(P<0.05). 2)After the treatment, the ALT, AST, TBIL and AKP in both groups were all significantly decreased compared to those before the treatment, and those in the the observation group were lower than those in the control group(P<0.05). 3)After the treatment, the Nrf2, NQO1, HO1, GSH-Px and CAT in the 2 groups were all lower than those before the treatment, and those in the observation group were lower than those in the control group(P<0.05). 4)WBC and NEUT% in the 2 groups were lower than those before the treatment after 3 d, 7 d and 15 d of treatment, and those in the observation group were lower than those in the control group after the treatment(P<0.05). 5)After the treatment, the TNF-α and NO of the patients in the 2 groups were lower than those before the treatment, and those in the observation group were lower than those in the control group.While IL-10 was higher than that before the treatment, and that in the observation group was higher than that in the control group(P<0.05). 6)After the treatment, the total clinical effective rate in the observation group was higher than that in the control group(P<0.05). 7)There was no significant difference in the rates of ADRs between the 2 groups(P>0.05).Conclusion:Sini Decoction combined with magnesium isoglycyrrhizinate can effectively reduce Nrf2 antioxidant indexes and inflammatory status in patients with drug-induced liver injury, improve their liver function, alleviate clinical symptoms, and improve the total effective rate of clinical treatment, without increasing the ADR rate in the patients.