Idiopathic Pulmonary Fibrosis: The CleanUP-IPF ランダム化臨床試験の成人の呼吸器科入院または死亡に対する抗菌薬療法の効果
Fernando J Martinez1, Eric Yow2, Kevin R Flaherty3
1New York Presbyterian Hospital/Weill Cornell Medicine, New York.
JAMA
|May 11, 2021
まとめ
コトリモクサゾールまたはドキシサイクリンによる抗菌薬療法は,イディオパシー性肺線維症の患者のアウトカムを改善しませんでした. この研究は,これらの抗生物質がこの肺疾患の治療に有益でないことを示唆しています.
科学分野:
- 肺科
- 感染症
- 臨床試験
背景:
- 肺の微生物群の変化は,イディオパシー肺線維症 (IPF) の進行と関連しています.
- 抗菌薬療法は,IPFの潜在的な治療法として研究されています.
研究 の 目的:
- 病原性肺線維症患者の臨床結果改善における抗菌薬療法の有効性を評価する.
- コトリモクサゾールまたはドキシサイクリンが非選択性呼吸器疾患の入院や全因死亡に与える影響を評価する.
主な方法:
- 米国35カ所のIPF患者513人を対象とした実用的なランダム化臨床試験です.
- 患者は通常治療と抗菌薬 (コトリモクサゾールまたはドキシサイクリン) を併用したか,または通常治療のみを受けた.
- 主なエンドポイントは,最初の非選択性呼吸器疾患入院までの時間または全原因死亡率でした.
主要な成果:
- 研究は無益で早期に終了した. 抗菌薬群と通常治療群の主要なエンドポイントでは有意な差は認められませんでした (調整HR,1. 04; P=0. 83).
- 腹や発疹などの有害事象は,抗菌薬群でより頻繁に見られました.
- 主要エンドポイントに関してコトリモクサゾールとドキシサイクリンとの間に有意な相互作用は認められなかった.
結論:
- コトリモクサゾールまたはドキシサイクリンを通常の治療に追加しても,イディオパシー性肺線維症の成人の臨床結果は有意に改善されなかった.
- 現在の証拠は,この特定の抗生物質の Idiopathic Pulmonary Fibrosis の治療のための使用を支持していません.
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