システィック線維症の小児における長期アジトロマイシン:ランダム化,プラセボ対照クロスオーバー試験
A Equi1, I M Balfour-Lynn, A Bush
1Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, London, UK.
Lancet (London, England)
|October 18, 2002
まとめ
アジトロマイシンは,システィック線維症の小児の肺機能にわずかな効果を示した. この抗生物質は,CF患者の口服抗生物質コースの必要性を減らす可能性があります.
科学分野:
- 肺内科 肺内科 肺内科
- 小児科は小児科です.
- 薬理学 薬理学とは
背景:
- マクロリド抗生物質であるアジトロマイシンは,抗炎症性を持っています.
- パイロット試験では,システィックフィブロシス (CF) の治療におけるアジトロマイシンの潜在的な臨床効果が示唆されました.
研究 の 目的:
- システィック線維症の小児におけるアジトロマイシンの有効性を公式に評価する.
主な方法:
- 15ヶ月のランダム化,ダブルブラインド,プラセボ対照クロスオーバー試験で,CFの41人の子ども (8~18歳) が参加した.
- 患者はアジトロマイシンまたはプラセボを6ヶ月間投与し,その後2ヶ月の洗い流しを行い,その後横断した.
- 主なアウトカムは,1秒間の強制排気量 (FEV1) の相対的差異であり,次要アウトカムには炎症マーカー,運動テスト,抗生物質使用が含まれていました.
主要な成果:
- FEV1の相対差の平均値は5.4%で,アジトロマイシン (p=0.059) に好意的であった.
- アジトロマイシン群では,経口抗生物質の投与が著しく少なく必要であった (p=0.005).
- 炎症マーカー,運動耐性,または主観的な幸福度の有意な変化は観察されなかった.
結論:
- アジトロマイシンの4〜6ヶ月の試験は,従来の治療法に反応しないCFの子供に正当化されています.
- CFにおけるアジトロマイシンの効果の正確なメカニズムは不明のままである.
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