腸の準備が不十分になるリスクが高い患者の短期間のリナクロチドとポリエチレングリコール:ランダム化,ダブルブラインド,多センター試験
Hui Chen1, Jun Wang2, Caixia Fan3
1Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China.
まとめ
リナクロチドとポリエチレングリコール (PEG) の併用は,高リスク患者の腸の準備やアデノマの検出を改善しませんでした. このレジメンは,右大腸のポリプ検出を増加させたが,特に高齢者の場合はそうであった.
科学分野:
- 胃腸内科 胃腸内科
- 結腸直腸がんスクリーニング
- クリニック・トライアル 臨床試験
背景:
- リナクロチドとポリエチレングリコール (PEG) の併用による腸の準備品質の向上と,不適切な準備のリスクの高い患者における腺腫の検出の有効性を評価する.
- この組み合わせ治療の利点に関する不確実性は,さらなる調査を必要とします.
研究 の 目的:
- プラセボとPEGと比較して,リナクロチドとPEGを併用した2日間のレジメンの有効性と安全性を評価する.
- 排便準備の適切性やアデノマ検出率に与える影響を判断する.
主な方法:
- 2022年8月から2023年7月にかけて実施された多センターランダム化試験です.
- 参加者はリナクロチドまたはプラセボを投与され,2日間PEGと併用した.
- 主なエンドポイントは,十分な腸の準備率と,コロノスコピーで検出されたアデノマの平均でした.
主要な成果:
- リナクロチドとプラセボのグループ間の適切な排泄率やアデノマ検出の平均値は,修正された治療意図とプロトコル分析の両方で有意な差異は見られなかった.
- リナクロチドとPEGの組み合わせは,右大腸で検出されたポリプの平均数の統計的に有意な増加をもたらしました (P=0.016).
- この右結腸ポリプ検出の増加は,70歳以上 (P=0.033) の患者で特に顕著でした.
結論:
- PEGと併用した2日間のリナクロチド療法は,高リスクの患者で腸の準備の適切さやアデノマ検出率を改善しなかった.
- 併用療法は,特に高齢の患者において,右結腸ポリプ検出の潜在的増加を示し,さらなる研究を正当化しました.
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