幼児期における重度のミオクロニック性におけるステリペントール:ランダム化プラセボ対照性症候群専用試験. STICLO 研究グループ
C Chiron1, M C Marchand, A Tran
1Department of Neuropaediatrics and INSERM U 29, Hospital Saint Vincent de Paul, Paris, France.
Lancet (London, England)
|November 23, 2000
まとめ
ステリペントールは,既存の治療に追加されたときに,乳児期の重症筋性 (SMEI) の小児における発作を効果的に軽減しました. この研究は,ステリペントール (stiripentol) を確認しています.
科学分野:
- 小児神経学について
- 薬理学 薬理学とは
- エピレプシの研究研究
背景:
- サイトクロームP450阻害剤であるステリペントールは,乳児期の重症筋性てんかん (SMEI) で潜在的な抗てんかん効果を示した.
- 以前のオープン・ラベル研究では,クロバザムとバルプロアートとの併用で有効性が示唆されていた.
研究 の 目的:
- SMEIと診断された小児における追加療法としてのスティリペントールの抗効性を確認する.
- ランダム化され,プラセボ対照試験の設定でスティリペントールの有効性を評価するために.
主な方法:
- SMEIを患っている41人の子どもを対象とした,ダブルブラインド,プラセボ対照試験です.
- 患者は2ヶ月間,バルプロアートとクロバザムの追加としてプラセボまたはスティリペントールを投与された.
- 発作の減少は,治療期間中のクローン発作またはトニック-クローン発作の頻度を1ヶ月のベースラインと比較して評価した.
主要な成果:
- プラセボと比較して,ステリペントール群では,有意に高い応答率 (71%対5%) が観察されました.
- ステリペントールを服用した15人の患者は発作頻度が50%以上減少し,9人は発作のない状態になった.
- ステリペントール治療は,発作頻度がベースラインから -69%変化し,プラセボでは +7% (p<0.0001) 減少した.
結論:
- アドオンステリペントールは,SMEIの小児における有意な抗効性を示しています.
- この結果は,小さな患者集団でも治療の有効性を明らかにできるため,特定の症候群に焦点を当てた研究の価値を裏付けています.
- 特定のタイプのエピレプシーに対するステリペントールのさらなる調査は正当化されています.
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