臨床試験の適格性のためのスピロメトリー基準:緊急再評価の時間
Idan Bokobza1,2,3, Melanie Le Sayec2,4, Cara Bossley2,4
1National Heart and Lung Institute, Imperial College London, London, UK.
Thorax
|September 4, 2025
まとめ
臨床試験の適格性に関するスピロメトリー方程式の切り替えは,患者へのアクセスに影響を及ぼします. 新しいGLI-Globalの方程式では700人以上の個人が除外され,公平なアクセスのための試験の値の見直しが必要になります.
科学分野:
- 肺医学
- 臨床試験の設計
- スピロメトリー基準
背景:
- 呼吸器科の臨床試験では,民族性依存のGLI-2012方程式に基づいて,1秒間に強制排気量 (ppFEV1) の40%から90%の値を使用することが一般的です.
- 国際的なガイドラインでは,より新しい"人種中立"のGLI-Globalスピロメトリー基準方程式を推奨しています.
研究 の 目的:
- GLI-2012からGLI-Global方程式への移行が呼吸器科臨床試験の適格性に与える影響を定量化する.
- UK Cystic Fibrosis Registry 内の患者へのアクセスを評価する.
主な方法:
- UK Cystic Fibrosis Registry (n=8182) からのスピロメトリーデータの分析
- GLI-2012とGLI-Globalの方程式を用いて計算したppFEV1値の比較
- 新しい方程式の下での90%のppFEV1適格性の値の効果をモデル化する.
主要な成果:
- GLI-Globalの方程式への移行は,特に90%のPPFEV1の上限で,新たに700人を対象外にするでしょう.
- この変更は,スピロメトリー方程式の選択に基づく試験アクセスにおける潜在的な格差を強調しています.
結論:
- 臨床試験の適格性における固定されたppFEV1の値の緊急の見直しは,GLI- Global方程式の採用によって必要である.
- 最初の勧告は, ppFEV1の資格範囲を30~95%に拡大し,民族間の平等なアクセスを確保することです.
- 臨床試験への参加に関する ppFEV1の制限値をより広く再評価することが必要である.
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