JP2021509108A - 肺高血圧症の治療のための吸入用一酸化窒素及び酸素の使用 - Google Patents
肺高血圧症の治療のための吸入用一酸化窒素及び酸素の使用 Download PDFInfo
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Abstract
Description
本発明の原理及び実施形態は、一般に、吸入用一酸化窒素送達の分野に関する。
低酸素血症は、肺動脈高血圧症(PAH)で生じる可能性がある。Revealレジストリは、60%のPAH対象が酸素療法を使用することを示した(Hap Faberによる要約発表、chest、2016)。PAHにおける低酸素血症は、様々なメカニズム:換気−灌流のミスマッチ、肺拡散能の低下、心拍出量の減少の状況での低酸素飽和度と混合静脈血の混合、又は肺内若しくは心臓内シャントの開口、によって引き起こされ得る(Porteous及びFitz、2014)。低酸素血症は、肺動脈血管収縮をもたらし、肺高血圧症を悪化させる可能性がある。Revealレジストリは、一酸化炭素の最も低い拡散能力(DLCO、空気嚢から肺血管へ通過する酸素の測定)40%未満を有するPAH患者は、酸素療法で治療された場合に、生存率がより良好であることを示した。
本発明のいくつかの例示的な実施形態を説明する前に、本発明は、以下の説明に記載した構成又はプロセスの工程の詳細に限定されるものではないことを理解すべきである。本発明は、他の実施形態及び様々な方法で実施又は実行することが可能である。
実施例1−PAHを有する患者における酸素飽和度低下及び運動能力に対する長期iNO療法並びにLTOTの効果
この研究は、PAH(IK−7001−PAH−201;NCT01457781)を有する症候性対象におけるアドオン治療としてのプラセボに対するパルスiNOの安全性、耐性及び有効性を決定するための第2相、プラセボ対照、二重盲検、ランダム化臨床試験であった。この研究の主要評価項目は、肺血管抵抗(PVR)におけるベースラインからの変化であった。副次評価基準は、6MWDにおける変化、第1の臨床的悪化事象(TTCW)までの時間、WHO機能クラスの変化、Borg呼吸困難スコア(BDS)の変化、及びSF−36ショートフォームバージョン2及びケンブリッジ肺高血圧アウトカムレビュー(CAMPHOR)によってスコア化される患者が報告した予後(PRO)の変化を含んだ。
Claims (20)
- 肺高血圧症を有する患者における酸素飽和度低下を低減する方法であって、
それを必要とする患者に有効量の長期酸素療法(LTOT)と組み合わせて有効量の吸入用一酸化窒素(iNO)を投与することであって、前記iNOが、少なくとも4週の間少なくとも約30mcg/kg IBW/時の用量で投与される、投与すること
を含む、方法。 - 肺高血圧症を治療する方法であって、
それを必要とする患者に有効量の長期酸素療法(LTOT)と組み合わせて有効量の吸入用一酸化窒素(iNO)を投与することであって、前記iNOが、少なくとも4週の間少なくとも約30mcg/kg IBW/時の用量で投与される、投与すること
を含む、方法。 - 酸素飽和度低下を低減することによって肺高血圧症を治療する方法であって、
それを必要とする患者に有効量の長期酸素療法(LTOT)と組み合わせて有効量の吸入用一酸化窒素(iNO)を投与することであって、前記iNOが、少なくとも4週の間少なくとも約30mcg/kg IBW/時の用量で投与される、投与すること
を含む、方法。 - 肺高血圧症を有する患者における運動能力を改善する方法であって、
それを必要とする患者に有効量の長期酸素療法(LTOT)と組み合わせて有効量の吸入用一酸化窒素(iNO)を投与することであって、前記iNOが、少なくとも4週の間少なくとも1日6時間少なくとも約30mcg/kg IBW/時の用量で投与される、投与すること
を含む、方法。 - 酸素飽和度低下を低減することによって肺高血圧症を有する患者における運動能力を改善する方法であって、
それを必要とする患者に有効量の長期酸素療法(LTOT)と組み合わせて有効量の吸入用一酸化窒素(iNO)を投与することであって、前記iNOが、少なくとも4週の間少なくとも約30mcg/kg IBW/時の用量で投与される、投与すること
を含む、方法。 - 前記iNOが、吸気の最初の半分の間に前記患者に投与される、請求項1〜5のいずれか一項に記載の方法。
- 前記iNOが、少なくとも1日に2時間投与される、請求項1〜6のいずれか一項に記載の方法。
- 前記iNOが、少なくとも1日に6時間投与される、請求項1〜7のいずれか一項に記載の方法。
- 前記iNOが、少なくとも1日に12時間投与される、請求項1〜8のいずれか一項に記載の方法。
- 前記肺高血圧症が、肺動脈高血圧症(WHOグループI)、左心疾患と関連付けられるPH(WHOグループ2)、肺疾患及び/又は慢性低酸素症に関連付けられる肺高血圧症(WHOグループ3)、慢性血栓塞栓性肺高血圧症(WHOグループ4)又は不明多因子機構を有する肺高血圧症(WHOグループ5)の1以上を含む、請求項1〜9のいずれか一項に記載の方法。
- 前記患者が、肺動脈高血圧症(WHOグループI)を有する、請求項1〜10のいずれか一項に記載の方法。
- 前記患者が、特発性肺線維症(IPF)又は慢性閉塞性肺疾患(COPD)に関連付けられるWHOグループ3肺高血圧症を有する、請求項1〜10のいずれか一項に記載の方法。
- 前記患者が、換気−灌流(V/Q)ミスマッチを有する、請求項1〜12のいずれか一項に記載の方法。
- 前記iNOが、少なくとも3ヶ月間投与される、請求項1〜13のいずれか一項に記載の方法。
- 前記iNOが、約30mcg/kg IBW/時〜約75mcg/kg IBW/時の用量で投与される、請求項1〜14のいずれか一項に記載の方法。
- 前記iNOが、約75mcg/kg IBW/時の用量で投与される、請求項1〜15のいずれか一項に記載の方法。
- 前記iNOの投与が、少なくとも1の16週間のiNO投与後の患者群における運動中のSpO2の低下における平均減少を提供する、請求項1〜16のいずれか一項に記載の方法。
- 前記iNOの投与が、約3.36の16週間のiNO投与後の患者群における運動中のSpO2の低下における平均減少を提供する、請求項1〜17のいずれか一項に記載の方法。
- 前記iNOの投与が、少なくとも10メートルの16週間のiNO投与後の患者群における6分間歩行距離(6MWD)運動における平均増加を提供する、請求項1〜18のいずれか一項に記載の方法。
- 前記iNOの投与が、約52.4メートルの16週間のiNO投与後の患者群における6分間歩行距離(6MWD)における平均増加を提供する、請求項1〜19のいずれか一項に記載の方法。
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