臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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42 巻, 4 号
選択された号の論文の28件中1～28を表示しています
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原著
  • A Clinical Trial Assessing the Efficacy and Safety of a New Injectable Formula of Sodium Phenobarbital Containing No Additives for the Treatment of Neonatal Seizures
    Kou KAWADA, Susumu ITOH, Yasushi ITANI, Hiroyuki KITAJIMA, Hiroyuki YO ...
    2011 年 42 巻 4 号 p. 205-210
    発行日: 2011年
    公開日: 2011/10/03
    DOIhttps://doi.org/10.3999/jscpt.42.205
    ジャーナル フリー
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    Aims: A new phenobarbital preparation for injection containing no additives (NOBELBAR®) was developed in Japan for safer use in neonates with seizures. This study was conducted to evaluate the clinical efficacy and safety of NOBELBAR® for the treatment of neonatal seizures.
    Methods: This investigator-initiated clinical trial was an open-label, uncontrolled, multicenter study, conducted in compliance with the good clinical practice. Phenobarbital was initially administered intravenously at a loading dose of 20 mg/kg. An additional dose of 20 mg/kg was given if the seizures did not resolve. The primary efficacy was evaluated 30 minutes after the administration of the loading dose. Infants who responded to the loading administration received maintenance therapy with 2.5 to 5 mg/kg intravenous phenobarbital once daily for 6 days.
    Results: NOBELBAR® was administered to 10 neonates with seizures. The primary efficacy was evaluated as complete response in all patients. Adverse events were reported in 9 of the 10 patients (90%), most of which were mild. Plasma phenobarbital concentrations ranged from 18.7 to 45.3 μg/mL.
    Conclusion: The study demonstrated that NOBELBAR® was effective for the control of neonatal seizures, and plasma drug concentrations were maintained within the therapeutic range. Approved for manufacturing and marketing was obtained based on the results of this study and other relevant data.
    (Clinical Trials. number, UMIN-C000000410, JMA-II A00002.)
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短報
第17回臨床薬理学講習会 （2010年度）　「医薬品開発の新しい動向」
受賞報告 （2009年度　臨床薬理研究振興財団賞学術奨励賞研究成果報告）
第31回　日本臨床薬理学会年会記録
シンポジウム 2　臨床試験と情報公開
シンポジウム 6　これからのCRC：臨床試験を支援するスタッフの教育
シンポジウム 10　臨床薬理におけるModeling & Simulationのためのメトリクス
シンポジウム 13　標準治療確立のための動脈硬化領域における医師主導臨床試験のあり方
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