多発性硬化症における持続放出型経口ファムプリジン:ランダム化,ダブルブラインド,制御試験
Andrew D Goodman1, Theodore R Brown, Lauren B Krupp
1University of Rochester, Rochester, NY, USA.
Lancet (London, England)
|March 3, 2009
まとめ
ファムプリディンは,多発性硬化症患者の歩行能力を有意に改善し,歩行障害を軽減しました. この臨床的に有意義な効果は,ファズIII試験で観察され,ファムプリジンによる効果が確認されました.
科学分野:
- 神経学 神経学とは
- 臨床薬理学 臨床薬理学とは
- リハビリテーション医学 リハビリテーション医学
背景:
- 臨床研究では,ファムプリジン (4-アミノピリジン) が多発性硬化症 (MS) の運動機能を強化することを示しています.
- この第3相試験では,MSに関連する外来欠乏症に対する持続性放出ファムプリディンを調査した.
研究 の 目的:
- 多発性硬化症および歩行障害を有する個体において,口服による長期放出ファムプリディンの有効性と安全性を評価する.
- タイムウォーキングテストに基づいてファムプリジン治療に反応した患者の割合を決定する.
主な方法:
- ランダム化,多センター,ダブルブラインド,プラセボ対照のフェーズIII試験です.
- 多発性硬化症の患者301人がランダムにファムプリジン (10 mg2回/日) またはプラセボを14週間に渡って投与されました.
- 応答は,タイム付き25フィートの散歩で一貫した改善によって定義される;主なアウトカムは,応答者の割合でした.
主要な成果:
- ファムプリジンで治療された患者の比率は,プラセボ (8%; p<0.0001) と比較して,タイムウォーク応答者 (35%) の割合が著しく高かった.
- ファムプリジンに反応した患者は,歩行速度の25.2%の改善を示し,治療中に維持されました.
- 回答者は,非回答者と比較して,12項目の多発性硬化症ウォーキングスケールで有意に大きな改善を示しました.
結論:
- 口服による持続性放出ファムプリジンは,多発性硬化症のある一部の個体において,歩行能力を効果的に改善します.
- 観察された歩行能力の改善は,患者によって報告された歩行障害の減少と関連しており,臨床的に有意義な治療効果を表しています.
- ファムプリディンの安全性プロファイルは,以前の調査と一致していました.
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