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フルチカゾンフロー酸とビランテロールの臨床試験における喘息抑制効果:オープン,並行グループ,ランダム化制御試験
Ashley Woodcock1, Jørgen Vestbo1, Nawar Diar Bakerly2
1Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, University of Manchester and University Hospital South Manchester NHS Foundation Trust, Manchester, UK.
Lancet (London, England)
|September 15, 2017
まとめ
フルチカゾンフロー酸とヴィランテロルの治療を開始すると,通常の治療と比較して患者の喘息のコントロールが著しく改善されました. この併用療法により,重篤な有害事象のリスクが増加することなく,喘息のコントロールが強化されたことが示されました.
科学分野:
- 肺科
- 臨床試験
- 薬剤療法
背景:
- 現在の喘息治療は,選択された患者グループでの有効性試験に依存しています.
- ランダム化試験は現実の臨床実務を反映するものです
研究 の 目的:
- フルチカゾンフロー酸/ヴィランテロルの投与の有効性を,症状性喘息の通常の治療と比較する.
- 一般診療での喘息の改善を評価する.
主な方法:
- イギリスの74の一般診療所を対象としたオープン・ランドマイズ・コントロール試験です.
- 症状のある喘息の患者は,フルチカゾンフロー酸/ヴィランテロルまたは通常の治療にランダムに割り当てられました.
- 主なエンドポイントは,24週で喘息コントロールテスト (ACT) のスコアが≥20または≥3の上昇であった.
主要な成果:
- フルチカゾーンフロー酸/ヴィランテロルを投与開始した患者は,24週間で治療応答率が高かった (OR2. 00,p< 0. 0001).
- フルチカゾンフローアート/ヴィランテロルで調整された平均ACTスコアは,通常の治療で2. 8ポイント増加した (差1. 6,p< 0. 0001).
- 肺炎やその他の重篤な有害事象の有意な差異は観察されなかった.
結論:
- フルチカゾンフロー酸塩/ ビランテロールを1日1回投与すると,維持用吸入器で症状のある喘息患者の喘息のコントロールが改善されました.
- この治療法は,通常の治療法と比べると有効で安全で,重篤な副作用のリスクは高まりませんでした.
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