オピオイド再発予防における延長放出ナルトレキソンとブプレノルフィンナロキソンの比較効果 (X:BOT):多センター,オープンラベル,ランダム化制御試験
Joshua D Lee1, Edward V Nunes2, Patricia Novo3
1Department of Population Health, New York University School of Medicine, New York, NY, USA.
Lancet (London, England)
|November 19, 2017
まとめ
延伸放出ナルトレゾン (XR- NTX) とブプレノルフィン- ナロキソン (BUP- NX) は,投与開始後,同様の安全性と有効性を示した. しかし,XR- NTXは,BUP- NXと比較して患者の再発率が高い.
科学分野:
- 依存症 医学
- 薬理学について
- 比較効果の研究
背景:
- 延長放出ナルトレキソン (XR- NTX) とブプレノルフィン- ナロキソン (BUP- NX) は,異なるオピオイド再発予防薬です.
- オピオイド使用障害 (OUD) の治療は,再発を軽減し,患者のアウトカムを改善することを目的としています.
研究 の 目的:
- OUD患者におけるXR-NTXとBUP-NXの間のオピオイド再発フリー生存を比較する.
- オピオイド再発予防におけるこの2つの薬剤療法の有効性と安全性を評価する.
主な方法:
- OUDを患った570人の参加者を対象とした24週間の無作為化試験です.
- 参加者は,XR- NTXの月間注射またはBUP- NXの毎日の注射にランダムに (1:1) 割り当てられました.
- 主なアウトカムは,オピオイド使用の特定の基準によって定義されたオピオイド再発のない生存率でした.
主要な成果:
- BUP- NX (94%) に比べてXR- NTX (72%) を開始した参加者は少なかった (p< 0. 0001).
- 治療意図群では,XR- NTXによる再発率 (65%) が,BUP- NXによる再発率 (57%) に比べて高かった (HR 1. 36).
- 開始後,両方の薬は,同様の再発率,安全性プロファイル,およびプロトコル毎の集団での有効性を示しました.
結論:
- XR- NTXの投与開始の難しさは,治療予定集団における全体的な再発率に悪影響を及ぼしました.
- XR- NTXとBUP- NXは,一度開始すると安全で有効であり,BUP- NXは開始の容易さで優れている.
- 将来の研究は,XR- NTX誘導と治療維持の改善に焦点を当てなければならない.
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