Safety evaluation of the novel antiseizure medication perampanel in the treatment of epilepsy in children
Objective:To evaluate the safety of perampanel(PER)adjuvant therapy in children with epilepsy.Methods:The safety of 3 months of perampanel treatment in children with epilepsy was retrospectively collected and evaluated.To assess the safety of perampanel using adverse events by the type and frequency during epilepsy treatment in all children.Results:A total of 88 children with epilepsy were included in this study.During the entire PER treatment period,41(46.59％)children with epilepsy experienced at least one adverse drug reaction.The most common adverse reactions were drowsiness(26.14％),dizziness(19.32％),mental and behavioral abnormalities(9.09％),and nausea/vomiting(4.55％).4 children discontinued PER treatment due to adverse effects.The plasma drug concentrations in the adverse drug reaction group after taking PER were significantly higher than that those in the group without adverse reactions[(0.56±0.46)μg·mL-1 vs(0.39±0.27)μg·mL-1,P＜0.05].The proportion of children with epilepsy at a PER plasma trough concentration＞0.98 μg·mL-1 was significantly higher in the adverse drug reaction group than that in the group without adverse drug reactions(21.95％vs 4.26％,P＜0.05).Conclusion:The safety of PER is relatively poor.The proportion of adverse reactions is high.It is very necessary to monitor the plasma drug concentration of PER treatment at any time during the drug process.
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