Skuteczność i tolerancja briwataceamu jako leku wspomagającego u dzieci z opornościową epilepsją: badanie prospektywne w jednym ośrodku

PURPOSE: To evaluate the clinical efficacy and tolerability of adjunctive brivaracetam (BRV) in children with drug-resistant epilepsy (DRE). METHODS: This single-center prospective cohort study enrolled children with DRE who received adjunctive BRV and were followed for 6 months. The primary outcome was the 50% seizure response rate at 3 months. Secondary outcomes included the 50% response rate and seizure-free rate at 6 months, adverse reactions, and retention rates assessed by survival analysis. RESULTS: A total of 104 patients were included (50 males and 54 females; median age at BRV initiation, 8.00 years). The most common seizure type was focal seizures (67.3%), and etiologies included genetic (13.5%), structural (21.1%), immune (5.8%), and unknown (59.6%) causes. The 50% seizure response rates were 54.8% (57/104) at 3 months and 47.1% (49/104) at 6 months. Corresponding seizure-free rates were 25.0% (26/104) and 20.2% (21/104), respectively. Survival analysis indicated a gradual decline in retention over time; however, the overall retention rate remained above 80%. Patients who responded to BRV had significantly higher retention rates than non-responders over the 6-month period (HR = 0.30, 95% CI: 0.11-0.77; p = 0.014). Adverse reactions were reported in 7.7% of patients, with irritability, dizziness, and somnolence as the most common. CONCLUSION: Adjunctive BRV therapy demonstrated favorable efficacy and good tolerability in children with DRE during short-term follow-up. These findings provide practical guidance for clinical decision-making and contribute to the real-world evidence from China on the use of adjunctive BRV therapy in pediatric DRE.