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Background Drug-induced liver injury is the third major liver disease, following viral hepatitis and fatty liver disease. Timely diagnosis and effective treatment are crucial in halting disease progression and improving cure rates. Kuhuang preparation has been widely used in treating acute and chronic hepatitis stemming from various causes, particularly in patients manifesting jaundice, demonstrating clear clinical efficacy and safety. Nonetheless, there remains a dearth of evidence-based medical data concerning the efficacy and safety of hepatoprotective measures in patients with acute drug-induced liver injury. Objective To evaluate the efficacy and safety of Kuhuang injection sequential Kuhuang granules in the treatment of drug-induced liver injury. Methods Using a randomized, positive-controlled, non-inferiority trial design, 93 patients diagnosed with acute drug-induced liver injury at Beijing Youan Hospital, Capital Medical University, between November 2021 and September 2023 were selected. These patients were allocated through single-center randomization, with 49 cases assigned to the experimental group and 44 cases to the control group. After receiving conventional hepatoprotective therapy for 4 weeks, the experimental group and the control group were treated with Kuhuang injection/ adenosylmethionine butanedisulfonate for injection for 2 weeks, followed by Kuhuang granules/enteric-coated tablets of adenosylmethionine butanedisulfonate for another 2 weeks. The efficacy rates of jaundice regression, as well as changes in key liver function parameters [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), total bilirubin (TBIL), total bile acid (TBA) ] at baseline, 2 weeks, and 4 weeks of treatment, along with their normalization rates, were compared between the two groups. Results A total of 4 patients fell off during treatment, including 3 patients in the experimental group and 1 patient in the control group. Following 2 and 4 weeks of treatment, there was no significant difference observed in the efficient rate of jaundice regression between the two groups (P>0.05). Similarly, no significant differences were detected in the levels of ALT, AST, ALP, GGT, TBIL, and TBA between the two groups at the 2-week and 4-week marks of treatment (P>0.05). Additionally, there were no notable variations in the recurrence rates of ALT, AST, ALP, GGT, TBIL, and TBA between the two groups following 2 and 4 weeks of treatment (P>0.05) . Conclusion Kuhuang Injection Sequential Kuhuang Granules has definite efficacy and good safety in the treatment of drug-induced liver injury, and is not inferior to adenosylmethionine butyldisulfonate for injection sequential enteric-coated tablets of adenosylmethionine butanedisulfonate.

OBJECTIVE: To evaluate the efficacy and economy of Kuhuang injection for viral hepatitis with damp heat syndrome. METHODS: The database was retrieved for the clinical research of Kuhuang injection and Shuganning injection in the treatment of viral hepatitis, the clinical efficacy was evaluated by the network Meta-analysis method, and the economical efficiency was evaluated by the minimum cost method. RESULTS: A total of 22 articles were included in this study. Network Meta-analysis showed that the efficacy of Kuhuang injection and Shuganning injection were basically the same. Results of the minimum cost method showed that the daily drug cost of Kuhuang injection (42. 52 yuan) was lower than that of Shuganning injection (323. 80 yuan). CONCLUSIONS: The efficacy of Kuhuang injection for viral hepatitis with damp heat syndrome is basically the same as Shuganning injection, yet the cost is lower than Shuganning injection, which has economic advantages. [ABSTRACT FROM AUTHOR]