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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]

Objective To establish a method for the assay of six active ingredients in Kuhuang injection and study the infusion stability prepared with three different solvents.Methods (1)UPLC-MS/MS was used to determine the contents of matrine, dioscin, emodin, rhein, aloe emodin, and saikosaponin A from Sophora flavescens, Rhubarb Artemisia oleracea, and Radix Bupleuri in Kuhuang injection. (2)36 hour stability study at room temperature was conducted on the infusions prepared with 5% glucose solution, 10% glucose solution and fructose injection.Results (1)6 active ingredients in Kuhuang injection were completely separated in 15 minutes and the peak area was linear with the concentration for each component. The stability of the solution was good within 24 hours and the average recovery rate was between 99.86% and 99.92%. (2)All three infusion was clear after 36 hours, no turbidity, sedimentation or color change. The pH value of 10% glucose infusion in the minimal dose group with indoor illumination was significantly increased after 8 h. The stability for shading group was better than illumination group. In the maximum dose group, the infusion made with fructose had micro particles after 24 hours and did not meet the requirements. All the rests met the requirements after 36 hours.Conclusion UPLC-MS/MS method is simple, accurate and reliable. It can be used for the determination of active ingredients in Kuhuang injection. Specifically, fructose injection is not a suitable solvent for Kuhuang injection. The infusion should be kept shaded to improve the stability. [ABSTRACT FROM AUTHOR]

To systematically evaluate the effectiveness and safety of Kuhuang injection in treating viral hepatitis. Eight electronic databases and clinic trials were searched to collect randomized controlled trials for the effect of Kuhuang injection in the treatment of viral hepatitis. According to the Cochrane Handbook 5.1, two independent reviewers screened out the literatures, extracted data and assessed the quality of thestudies included. RevMan5.3 software was used for the data analysis. A total of 32 articles were included, involving 3 188 patients, including male 1 951 cases (61.2%), female 859 cases (26.9%), and 378 cases of unknown sex (11.9%). All the clinical studies showed a low quality. Due to the complication of diseases and difficulty in intervention measures, most trails were classified by the condition of diseases, and then a descriptive analysis was made. The results showed that the test group was better than the control group in total efficiency of treating severe icteric viral hepatitis, and the test group was advantageous over the control group in jaundice removal and liver function recovery rate in treating icteric hepatitis. In the Meta-analysis on the RCTs for icteric viral hepatitis, the total efficiency of Kuhuang injection + comprehensive treatment group was higher than that of the comprehensive treatment group （RR=1.35, 95%CI=[1.10,1.66], P=0.61）. In addition, when Kuhuang injection was dripped too fast, patients had such adverse reactionsas dizziness, palpitation, nausea, vomiting and skin rash, which could be relieved at a lower dripping speed.Based on the existing evidences, Kuhuang injection had a certain effect in treating viral hepatitis. Most clinic trails did not include viral hepatitis etiology, clinical classification and diversified intervention measures, which resulted in a high clinical heterogeneity and poor comparability between trails. Besides, most trials had a low methodological quality, which affected the authenticity of the results. Therefore, more high-quality, multi-center, large-sample, randomized double-blind controlled trialsarerequired to prove the evidences., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)