周辺動脈疾患の患者の歩行能力に対する,監督された運動によるまたはそれなしの粒細胞マクロファージコロニー刺激因子の効果:PROPELランダム化臨床試験
Mary M McDermott1,2, Luigi Ferrucci3, Lu Tian4
1Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
JAMA
|November 16, 2017
まとめ
外周動脈疾患 (PAD) の患者では,監督されたトレッドミルの運動により歩行距離が有意に改善されました. グラヌロサイト・マクロファージ・コロニー刺激因子 (GM- CSF) は,単独または運動と併用しても,これらの効果を高めませんでした.
科学分野:
- 心血管医学
- 再生医療
- 臨床試験
背景:
- 周辺動脈疾患 (PAD) は歩行能力を低下させ,その改善における粒細胞マクロファージコロニー刺激因子 (GM-CSF) の役割は不明である.
- 歩行運動は,前立腺細胞の放出を促進し,不血症の筋肉に誘導することで,PADにおけるGM-CSF効果を高める可能性があります.
研究 の 目的:
- GM-CSFと監視されたトレッドミルの運動が,単独の運動またはGM-CSFと比べて6分間の歩行距離を改善するかどうかを評価する.
- プラセボよりも6分の歩行距離を改善するかどうかを判断する.
- 運動だけで6分の歩行距離が 注意力コントロールの介入よりも改善するかどうかを評価する.
主な方法:
- PADの参加者210人を含む2x2ファクトリアルデザインのランダム化臨床試験.
- 参加者は,運動+GM-CSF,運動のみ,GM-CSFのみ,または注意コントロール+プラセボの4つのグループに分けられました.
- 介入には,GM-CSFまたはプラセボを皮下投与した6ヶ月の監督されたトレッドミルの運動または教育講義が含まれていました.
主要な成果:
- 監視されたトレッドミルの運動は,注意のコントロールグループと比較して,6分間の歩行距離を大幅に改善しました (平均差は+33. 6m,P=0. 02).
- GM-CSFは,単独でも運動と併用しても,プラセボまたは運動のみと比較して,6分間の歩行距離を有意に改善しませんでした.
- 運動+GM-CSFは,運動のみに比べて有意な改善を示さなかった (平均差は - 6. 3m,P=.61).
結論:
- PAD患者の歩行能力を改善する効果があります.
- GM-CSFは,PADにおける歩行障害に対して,単独または運動と併用して追加的な効果を提供するものではありません.
- これらの発見は,PADに関連する歩行障害の主要な治療方法として運動を支持しますが,GM-CSFの使用を支持しません.
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