クラリトロマイシンの臨床効果と,慢性鼻炎と無鼻炎の成人の内視鏡外科手術 (MACRO):プラグマティック,多中心,三腕,ランダム化,プラセボ対照のフェーズ4試験
Carl Philpott1, David J Beard2, Elnaz Saeedi3
1Norwich Medical School, University of East Anglia, Norwich, UK; James Paget University Hospital, Norfolk & Waveney ENT Service, Norfolk, UK.
Lancet (London, England)
|August 30, 2025
まとめ
クラリトロマイシンやプラセボと比較して,内視鼻腔手術は慢性鼻炎患者の生活の質を大幅に改善します. 長期にわたる低用量クラリトロミシンは,この状態の管理に日常的に使用することが推奨されていません.
科学分野:
- 耳鼻喉科
- 臨床医学
- 薬理学について
背景:
- 慢性鼻炎 (CRS) の管理には堅実な証拠がないため,手術と抗生物質治療の頻度は大きく異なっています.
- 鼻内薬を含む既存の治療法では,しばしばCRS患者の症状を十分に緩和することができません.
研究 の 目的:
- CRS の成人における内視鼻腔外科手術 (ESS) の臨床効果と,クラリトロミシン治療の3ヶ月間の臨床効果を比較する.
- 疾患特有の生活の質に対するこれらの介入の影響を評価する.
主な方法:
- プラセボ対照のプラグマティック・3アーム・ランドマイズ・フェーズ4試験で,症状のあるCRS患者514人が参加した.
- 参加者はESS,クラリトロミシン,またはプラセボに分けられ,すべて鼻内投与を受けた. 主なアウトカムは6ヶ月のSNOT-22生活の質スコアでした.
主要な成果:
- 6ヶ月後の内視鼻腔手術では,クラリトロマイシン (p< 0. 0001) とプラセボ (p< 0. 0001) と比べ,SNOT - 22のスコアが著しく低下しました.
- クラリトロマイシンとプラセボ群のSNOT-22スコアに有意な差は認められなかった (p=0. 17).
- 重篤な有害事象は3つのグループ全体で低くて比較可能でした.
結論:
- 慢性鼻炎では内視鼻腔手術が臨床的に有効で,6ヶ月で疾患特有の生活の質を大幅に改善します.
- 低用量のクラリトロミシンを長期にわたって日常的に使用することは,これらの結果によって支持されていません.
- 症状のコントロールには,鼻内投与だけでは不十分である場合,ESSを推奨する.
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