小児部分てんかんにおけるレベチラセタム併用療法の効果と安全性

Efficacy of Levetiracetam as an Add-on Therapy in Children with Localization-related Epilepsy

レベチラセタム（LEV）併用療法を施行した4〜15歳（平均9.4歳）の小児部分てんかん患者70例について24週間の観察を行い，有効性と安全性を評価した。発作頻度減少率50%以上の有効例は57%であった。副作用は34%で認められ，内訳は眠気，倦怠感，興奮であった。継続率は87%であった。維持用量は平均39.9mg/kg/日であった。本研究でLEVの高い発作抑制効果と忍容性が示された。

Abstract

Objective: To clarify the efficacy and safety of levetiracetam (LEV) in children with localization-related epilepsy, we performed a retrospective study in our hospital. Methods: We reviewed the cases of 70 pediatric patients (mean age, 9.4 years, range 4-15 years) who had undergone LEV add-on therapy between October 2010 and September 2014. The subjects were followed for a period of 24 weeks. Results: The mean starting dose was 9.9 mg/kg/day, and the mean final dose was 39.9 mg/kg/day. The LEV continuation rate was estimated to be 87%. The responder rate (based on ≥50% reduction in seizure frequency) was 57%. Twenty-four of the 70 patients experienced side effects, such as drowsiness, fatigue, and aggressiveness. Although most of the adverse events were mild and tolerable, it was necessary to discontinue the medication in four patients. We evaluated the effects of gender, age, duration of illness, secondarily generalized seizure, baseline seizure frequency, MRI abnormality, number of previously administered drugs, number of concomitant drugs, and final dose. MRI abnormality and final dose of LEV had a statistically significant influence on the efficacy. Conclusion: LEV can be used as an effective and safe add-on treatment in children with localization-related epilepsy.

(Received April 8, 2015; Accepted May 15, 2015; Published October 1, 2015)