てんかん重積状態あるいはてんかん発作頻発状態の患者を対象としたロラゼパム静脈内投与時の有効性と安全性の検討

Efficacy and Safety of Lorazepam Intravenously Administered in Subjects with Status Epilepticus or Repetitive Seizures

てんかん重積状態あるいはてんかん発作頻発状態の患者26名に，ロラゼパム（LZP）を静脈内投与した。初回投与終了後10分以内に発作が消失し，投与終了後30分以内に再発しない患者は48.0％（12/25名）であったが，初回投与後10〜30分までの2回目の追加投与を含めた全投与後の有効率は64.0％（16/25名）であった。LZPと関連のある重篤または重度の有害事象はなく，有害事象による投与中止もなかった。

Abstract

We evaluated the efficacy and safety of lorazepam (LZP) 4 mg for adults (age, 16 years old or older) or 0.05mg/kg for children (age, 3 months to less than 16 years) as a slow intravenous injection in 26 Japanese patients with status epilepticus or repetitive seizures. The proportion of patients whose initial seizure stopped within 10 minutes and who continued seizure-free for at least 30 minutes after the completion of initial dose as the primary endpoint was 48.0% (12/25, 95%CI: 27.8%-68.7%). However, the proportion of patients whose seizures stopped within 10 minutes and who continued seizure-free for at least 30 minutes after the completion of either initial or second dose (in 10 to 30 minutes from the initial dose) was 64.0% (16/25, 95%CI: 42.5%-82.0%) in total, and 77.8% and 56.3% in adults and children, respectively. The most common adverse events (AEs) were somnolence (7.7%) and insomnia (7.7%), and almost all AEs were mild or moderate in severity. No patient experienced serious or severe LZP-related AEs. No one discontinued the study due to AEs.