出産後の出血に対するトランキサム酸: ランダム化制御試験の体系的レビューと個々の患者データメタ解析
Katharine Ker1, Loïc Sentilhes2, Haleema Shakur-Still1
1Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
Lancet (London, England)
|October 26, 2024
まとめ
トラネキサム酸は,女性における生命を脅かす産後出血のリスクを大幅に軽減します. 重度の出血が起こる前に,高リスクの個人に使用することを示唆しています.
科学分野:
- 産婦人科
- 薬理学について
- 臨床試験
背景:
- 産後出血 (PPH) は 母親の死亡の主な原因です.
- トラネキサム酸はPPH治療に推奨されているが,その予防的役割は不明である.
- 出産中の重度の出血を予防するトランキサム酸の有効性に関する証拠は限られている.
研究 の 目的:
- ランダム化制御試験 (RCT) の個々の患者データ (IPD) のメタ分析を体系的に検討し,実施する.
- 出産中の女性における生命を脅かす出血および血栓塞栓症の予防におけるトランキサム酸の効果を評価する.
- 患者のリスク因子と投与タイミングに基づいてトランキサム酸の効果の潜在的変化を調査する.
主な方法:
- WHO国際臨床試験登録プラットフォームを通じて特定されたRCTの体系的なレビューとIPDメタ解析.
- 含有基準: 予期登録,プラセボ対照,500人以上の女性,バイアスのリスクは低い.
- 主なアウトカム: 命に関わる出血と血栓塞栓症. 一段階モデルを使って分析した.
主要な成果:
- 54,404人の女性 (IPDは43,409) のデータを分析した.
- トランキサム酸は生命を脅かす出血を減少させた (0. 65% 対 0. 85%; OR 0. 77; p=0. 008).
- 血栓塞栓事件の有意な差はありません (0. 2% 対 0. 2%; OR 0. 96; p=0. 82). リスク,出産の種類,貧血,タイミングによって影響は変わらなかった.
結論:
- トランキサム酸は,生命を脅かす産後出血のリスクを効果的に軽減します.
- トランキサム酸が血栓形成のリスクを高める証拠はない.
- 高リスクの女性では,すべての出産に推奨されないが,PPHの診断前にトランキサム酸を考慮する.
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