オピオイド依存症のための注射延長放出ナルトレクソン:ダブルブラインド,プラセボ対照,多センターランダム化試験
Evgeny Krupitsky1, Edward V Nunes, Walter Ling
1Bekhterev Research Psychoneurological Institute, St Petersburg State Pavlov Medical University, St Petersburg, Russia. kruenator@gmail.com
Lancet (London, England)
|May 3, 2011
まとめ
延長放出ナルトレクソン (XR-NTX) は,オピオイド依存症患者の禁欲率を大幅に改善し,渇望を軽減しました. この注射可能な治療法は,伝統的なオピオイドアゴニスト療法に対する有望な代替手段です.
科学分野:
- 薬理学 薬理学とは
- 依存症医学 薬物中毒医学
- クリニック・トライアル 臨床試験
背景:
- オピオイド依存症は,治療への関与が低く,再発率が高い重要な公衆衛生問題です.
- 現在の治療法は,しばしば,遵守と有効性に関する課題に直面します.
- オピオイド依存症管理のための新しい治療法が必要である.
研究 の 目的:
- 注射可能な延長放出ナルトレキソン (XR-NTX) の有効性,安全性,および患者によって報告されたアウトカムを評価する.
- 解毒後のオピオイド依存症患者のXR-NTXを評価する.
- ランダム化制御試験の設定でXR-NTXとプラセボを比較する.
主な方法:
- ロシアの250人の患者が参加した24週間の,ダブルブラインド,プラセボ対照,ランダム化試験です.
- 患者は380mgのXR-NTXまたはプラセボを受け,心理社会的カウンセリングと併用した.
- 主要エンドポイントは断食が確認され,次要エンドポイントは,オピオイドフリーの日,食欲,リテンション,再発率でした.
主要な成果:
- XR-NTXグループは,確証された禁欲率 (90.0%対35.0%,p=0.0002) が著しく高かった.
- XR-NTXを受けた患者は,より多くのオピオイドフリーデー (99.2%対60.4%,p=0.0004) と,食欲の減少 (p<0.0001) を報告した.
- XR-NTXは優れたリテンション率 (p=0.0042) と著しく低い再発率 (p<0.0001) を示した.
結論:
- 注射用XR-NTXは,解毒後のオピオイド依存症の有効で安全な治療法です.
- XR-NTXは,オピオイドアゴニスト維持療法の明確な代替案を提供します.
- 心理社会的サポートと組み合わせると,XR-NTXは患者の治療受容性と治療結果を改善する可能性があります.
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