重度の細菌性髄膜炎における誘発性低体温:ランダム化臨床試験
Bruno Mourvillier1, Florence Tubach, Diederik van de Beek
1Réanimation Médicale et Infectieuse, Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Bichat-Claude Bernard, Université Paris Diderot, Sorbonne Paris Cité, Paris, France.
JAMA
|October 10, 2013
まとめ
誘発性低体温症は,重度の細菌性髄膜炎患者のアウトカムを改善せず,死亡率を増やす可能性があります. 更に安全性評価は,重症病院での将来の低体温試験に不可欠です.
科学分野:
- 神経学 神経学とは
- 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:
- 急性細菌性髄膜炎,特に肺炎球菌性髄膜炎は,治療の進歩にもかかわらず,高い死亡率と罹患率を持っています.
- 誘発性低体温症は,全身大脳低酸素症を含む状態において有益であることが示されています.
研究 の 目的:
- 誘発性低体温が重度の細菌性髄膜炎を患った昏睡状態の成人におけるアウトカムを改善するかどうかを評価する.
主な方法:
- バクテリア性髄膜炎の昏睡状態の98人の患者を含む多センター,オープンラベル,ランダム化臨床試験です.
- 患者は48時間32~34°Cまで冷却された (低体温群) または標準的なケアを受けた (対照群).
- 主なアウトカムは,グラスゴーアウトカムスケールの3ヶ月のスコアであったが,安全性上の懸念のため,試験は早期に中止された.
主要な成果:
- 試験は,低体温群の死亡率がコントロール群 (31%) に比べて (51%) 大幅に高かったため,早期に終了されました.
- 3ヶ月の不良結果は,低体温群でも高かった (86%対74%),統計的に有意ではなかった.
- ポストホック分析は,低体温の利点を示すために,無駄な可能性が高いことを示しました.
結論:
- 適度な低体温症は重度の細菌性髄膜炎のアウトカムを改善せず,有害である可能性があります.
- 低体温症を調査する将来の試験には,特にセプティックショックや脳卒中を患った患者の場合,注意深い安全性評価が必要です.
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