小児急性肺損傷における外因的表面活性物質 (カルファクタン) の効果:ランダム化制御試験
Douglas F Willson1, Neal J Thomas, Barry P Markovitz
1Department of Pediatrics, University of Virginia Health System, Children's Medical Center, Charlottesville, VA 22908, USA. dfw4m@virginia.edu
JAMA
|January 27, 2005
まとめ
カルファクタントは,小児急性肺損傷 (ALI) 患者の酸素供給を改善し,死亡率を下げましたが,呼吸不全期間を短縮することはありませんでした. この研究は,若い患者におけるALI治療の希望を示しています.
科学分野:
- 小児重症治療薬は,小児重症治療薬として使用されています.
- 肺内科 肺内科 肺内科
- ネオナタロジーの新生児科
背景:
- 子どもにおける急性肺損傷 (ALI) は,表面活性物質の機能不全と関連しています.
- 過去の成人ALIにおけるサーファクタント療法試験は失敗した.
- 予備的な研究では,天然の肺表面活性剤 (カルファクタン) が小児のALIに利益をもたらす可能性があることが示唆されています.
研究 の 目的:
- ALIを患っている乳児,子供,青少年における内側内カルファクタンスの挿入の有効性を評価する.
- カルファクタン治療が小児ALI患者における呼吸不全の期間を短縮するかどうかを判断する.
主な方法:
- 153人の小児ALI患者のカルファクタンとプラセボを比較したマルチセンター,ランダム化,盲検試験.
- 患者は12時間の間隔でカルファクタンまたは空気プラセボを2回投与された.
- 主なアウトカムには,呼吸器のない日数と死亡率が含まれていたが,二次的なアウトカムは,病院の経過と機械呼吸器への反応を評価した.
主要な成果:
- カルファクタントは,投与後急激に酸素化を著しく改善した (P = .01).
- 死亡率は,カルファクタン群でプラセボ群と比較して有意に低かった (OR,2.32;95%CI,1.15-4.85).
- 呼吸器のない日,集中治療室での滞在,または入院での滞在において,有意な違いは観察されなかった.
結論:
- カルファクタントは,酸素化の急性効果を示し,小児性ALIにおける死亡率を低下させる.
- カルファクタンはこの小児集団における呼吸不全の経過を著しく短縮することはなかった.
- ALIにおけるカルファクタン治療のための最適な投与量または患者の選択をさらに研究することが可能である.
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