Japanese

Efficacy and Safety of Lorazepam Intravenously Administered in Subjects with Status Epilepticus or Repetitive Seizures Yoko Ohtsuka 1 , Nobukazu Nakasato 2 , Yoshiomi Nakazuru 3 , Michinori Terada 3 1Asahigawaso Rehabilitation and Medical Center 2Department of Epileptology and Department of Electromagnetic Neurophysiology, Tohoku University Graduate School of Medicine 3Development Japan, Pfizer R&D Japan Keyword: ロラゼパム , てんかん重積状態 , てんかん発作頻発状態 , 有効性 , 安全性 , lorazepam , status epilepticus , repetitive seizures , efficacy , safety pp.901-910
Published Date 2019/8/1
DOI https://doi.org/10.11477/mf.1416201373
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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.


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電子版ISSN 1344-8129 印刷版ISSN 1881-6096 医学書院

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