Pakistan Journal of Pharmaceutical Sciences

Abstract: Background: Acute alcohol intoxication (AAI) is a common emergency with no specific antidote. Metadoxine has shown potential but lacks sufficient real-world evidence, particularly in Chinese populations. Objectives: To evaluate the clinical efficacy and safety of metadoxine in patients with acute alcohol intoxication. Methods: This single-center retrospective cohort study included 124 patients with AAI admitted to an emergency department between January and December 2024. Patients were divided into metadoxine plus conventional treatment (n=62) or conventional treatment alone (n=62) after propensity score matching. Primary outcomes were time to consciousness recovery (Glasgow Coma Scale ?14) and treatment effectiveness rate (symptom improvement within 6 hours without treatment escalation). Secondary outcomes included time to symptom relief, emergency stay, time to vital sign stabilization, blood ethanol decline rate, adverse reactions, and liver function changes. Results: Metadoxine significantly shortened consciousness recovery time (3.05±1.45 vs. 5.65±1.58 hours, mean difference ?2.60 hours, 95% CI: ?3.14 to ?2.06, p < 0.001) and improved treatment effectiveness rate (93.5% vs. 77.4%, OR=4.04, 95% CI: 1.30–12.56, p = 0.011). All secondary outcomes were significantly better in the metadoxine group (p < 0.001 for time-related outcomes and blood ethanol decline). No significant differences were observed in adverse reactions (9.68% vs. 6.45%, p = 0.510) or post-treatment liver enzyme abnormalities (12.90% vs. 16.13%, p = 0.610). Subgroup analysis showed a significant interaction by initial Glasgow Coma Scale (p = 0.037), indicating greater efficacy in patients with moderate-to-severe impairment. Conclusion: Metadoxine, when added to conventional supportive therapy, significantly accelerates consciousness recovery and improves clinical outcomes in acute alcohol intoxication without increasing short-term adverse events. The benefit appears more pronounced in patients with lower Glasgow Coma Scale scores.