関連する実験動画
6歳から14歳の子供の慢性喘息に対するモンテルカスト:ランダム化,ダブルブラインド試験. 小児用モンテルカスト研究グループ
B Knorr1, J Matz, J A Bernstein
1Department of Pulmonary-Immunology, Merck Research Laboratories, Rahway, NJ 07065, USA.
JAMA
|April 29, 1998
まとめ
モンテルカストは,喘息の小児の肺機能を有意に改善しました. この研究は,モンテルカストが小児性喘息の効果的な治療法であり,若い患者の午前FEV1を高めることを示しています.
科学分野:
- 小児肺病学について
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- レウコトリエンは,喘息の重要な媒介体であり,支管管収縮と呼吸道炎症を引き起こす.
- 以前の研究では,ルオコトリエン阻害剤は,成人および喘息の青少年に有益であることを示しました.
- 12歳未満の子どもは,高い喘息の流行率を持つ人口集団であり,標的型研究が欠けていました.
研究 の 目的:
- レウコトリエン受容体の抗体であるモンテルカストの臨床効果を評価する.
- 6歳から14歳の喘息児の肺機能に対するモンテルカストの効果を評価する.
主な方法:
- 8週間の,多センター,ランダム化,ダブルブラインド,プラセボ対照試験.
- 中等から重度の喘息を患っている336人の子ども (6~14歳) が参加しました.
- 患者は毎日5mgのモンテルカストまたはプラセボを投与され,朝のFEV1が主なアウトカムでした.
主要な成果:
- モンテルカスト群は,出発点から午前FEV1の8.23%の増加を示しました.
- プラセボ群は,午前FEV1がベースラインから3.58%増加した.
- グループ間の差異は統計的に有意であった (P<.001).
結論:
- モンテルカストは,慢性的な喘息の6~14歳の子供における午前FEV1を効果的に改善します.
- この研究は,小児性喘息管理の有効な治療選択肢としてモンテルカストを支持しています.
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