予測された重症急性炎におけるプロバイオティクスの予防:ランダム化,ダブルブラインド,プラセボ対照試験
Marc Gh Besselink1, Hjalmar C van Santvoort1, Erik Buskens2
1Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
Lancet (London, England)
|February 19, 2008
まとめ
プロバイオティクスの予防は,重度の急性炎の感染症合併症と死亡リスクの増加を予防しませんでした. これらの患者では,腸不全を含む潜在的な害のためにプロバイオティクスを避けるべきです.
科学分野:
- 胃腸内科 胃腸内科
- クリティカルケア・メディシン
- 感染症 感染症は感染症です.
背景:
- 感染症による合併症と死亡率は,急性炎において重大な懸念事項である.
- 腸内プロバイオティクスは感染を予防する可能性があるが,証拠は限られている.
- この研究では,予測された重症急性炎におけるプロバイオティクスの予防を評価した.
研究 の 目的:
- 予見される重症急性炎の患者における感染症合併症の軽減におけるプロバイオティクスの予防療法の有効性を評価する.
- この患者群の死亡率に対するプロバイオティクスの予防効果の影響を決定する.
主な方法:
- マルチセンター,ランダム化,ダブルブラインド,プラセボ対照試験で,重度の急性炎を予見した298人の患者が参加しました.
- 患者は,多種のプロバイオティクス製剤またはプラセボを28日間,毎日2回腸内投与した.
- 主要エンドポイントは,90日間のフォローアップで,感染症合併症の複合体でした.
主要な成果:
- 感染症の合併症は,プロバイオティック群の30%で,プラセボ群の28%で発生しました (RR 1.06,95%CI 0.75-1.51).
- 死亡率はプラセボグループ (6%) と比較してプロバイオティクスのグループ (16%) で有意に高かった (RR 2.53,95%CI 1.22-5.25).
- 益生菌群の9人の患者は腸内 ischemiaを発症し,8人の死亡が認められたが,プラセボ群では発症しなかった (p=0.004).
結論:
- プロバイオティクスの予防は,予測された重症急性炎の感染症合併症を軽減しませんでした.
- プロバイオティクスの使用は,死亡率の上昇と,腸不全のリスクの上昇と関連していました.
- 予見される重症急性炎の患者にプロバイオティクスの予防接種は行わないこと.
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