慢性閉塞性肺疾患の急性悪化における短期対従来のグルココルチコイド治療:REDUCEランダム化臨床試験
Jörg D Leuppi1, Philipp Schuetz, Roland Bingisser
1Clinic of Internal Medicine, University Hospital of Basel, Switzerland.
JAMA
|May 23, 2013
まとめ
慢性閉塞性肺疾患 (COPD) の悪化に対する全身性グルココルチコイドの5日コースは,14日コースと同じくらい効果的です. この短い治療は,臨床結果を損なうことなく,ステロイドの曝露を軽減します.
科学分野:
- 肺内科 肺内科 肺内科
- 臨床薬理学 臨床薬理学とは
背景:
- 国際的なガイドラインは,慢性閉塞性肺疾患 (COPD) の急性悪化に対して,全身性グルココルチコイドを7〜14日間投与することを推奨しています.
- COPDの悪化に対する最適なグルココルチコイド用量と持続時間は未定義のままです.
研究 の 目的:
- 5日間の全身性グルココルチコイド治療が,COPD悪化の14日間の治療に劣らないかどうかを判断する.
- 短期的なグルココルチコイド治療が患者のステロイド被曝を減少させるかどうかを評価する.
主な方法:
- 314人の患者が参加したランダム化,非劣等性,多センター試験 (重症性COPDにおけるコルチコステロイドの使用の減少).
- 患者は,毎日40mgのプレドニゾンを5日間または14日間,ダブルブラインドでプラセボでコントロールされた方法で投与されました.
- プライマリアウトカムは,180日以内の次の悪化までの時間であり,非劣等差は1.515の危険比で設定されました.
主要な成果:
- 5日間の治療は14日間の治療に劣らず,危険比率は0.95 (治療意図) と0.93 (プロトコル毎) であった.
- 180日間の再発症率は37.2% (5日間のグループ) と38.4% (14日間のグループ) と同様でした.
- 14日間のグループでは,累積プレドニゾンの量 (793 mg vs 379 mg) が著しく高かったが,いずれのグループでも副作用の増加は認められなかった.
結論:
- 全身性グルココルチコイドの5日コースは,急性COPD悪化の管理のための14日コースに劣らずです.
- 短期間のグルココルチコイド治療は,ステロイドの全体的な曝露を大幅に減少させます.
- これらの発見は,急性COPDの悪化に対する5日間のグルココルチコイド療法の使用を支持する.
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