pediatric status epilepticusのためのロラゼパムとディアゼパム:ランダム化臨床試験
James M Chamberlain1, Pamela Okada2, Maija Holsti3
1Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN).
JAMA
|April 24, 2014
まとめ
ロラゼパムは,ランダム化試験において,小児のステータス・エピレプティクス治療において,ディアゼパムと比較して,改善された有効性または安全性を示さなかった. これらの発見は,この状態に対するロラゼパムの好ましい使用を支持しません.
科学分野:
- 小児救急医療について
- 臨床薬理学 臨床薬理学とは
- 神経学 神経学とは
背景:
- ベンゾジアゼピンは,小児の状態性の第一線治療である.
- ローラゼパムは,ディアゼパムよりも効果的または安全であると示唆されていますが,この indikacionのためにFDAによって承認されていません.
研究 の 目的:
- 小児の状態性の治療におけるロラゼパムとディアゼパムの有効性と安全性を比較する.
主な方法:
- ダブルブラインドでランダム化された臨床試験で,コンvulsive status epilepticus の273人の小児患者が参加しました.
- 患者は静脈内投与ダイアゼパム (0.2 mg/kg) またはロラゼパム (0.1 mg/kg) を投与し,再投与の選択肢がありました.
- 主なアウトカムには,発作の停止と人工呼吸器の必要性が含まれていました.
主要な成果:
- 効果はグループ間で類似した:ダイアゼパムでは72.1%で,ロラゼパムでは72.9%であった.
- 助呼吸率も同様でした:ディアゼパムでは16.0%,ロラゼパムでは17.6%でした.
- ローラゼパムは鎮静性の増加と関連していました (66.9% vs. 50%).
結論:
- ロラゼパムは,小児の状態のエピレプシスに対するディアゼパムと比較して,より優れた有効性または安全性を実証しませんでした.
- 現在の発見は,この状態に対するロラゼパムの好ましい使用を支持しません.
- 更に研究が進められれば,小児の状態におけるベンゾジアゼピン最適の選択が検討されるかもしれない.
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