緊急避妊用のウリプリスタルアセテートとレボノルゲストレル:ランダム化非劣等性試験とメタ解析
Anna F Glasier1, Sharon T Cameron, Paul M Fine
1National Health Service Lothian, Edinburgh, UK. Anna.Glasier@nhslothian.scot.nhs.uk
Lancet (London, England)
|February 2, 2010
まとめ
ウリプリスタルアセテートは,緊急避妊の有効な代替品であり,無防備性行為後最大5日間の予期せぬ妊娠の信頼性の高い予防を提供します. この方法はレボノルゲストレルと同等の安全性と有効性を示し,女性および医療従事者にとって貴重な選択肢となっています.
科学分野:
- 生殖器保健は,生殖器の健康についてです.
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- 現在の緊急避妊法 (EC) は時間的に敏感で,無防備の性行為と排卵の直前にできるだけ早く使用する必要があります.
- ユリプリスタルアセテート (UPA) とレボノルゲストレル (LNG) の有効性と安全性は,ECの直接比較を必要とする.
研究 の 目的:
- 緊急避妊用のウリプリスタルアセテートとレボノルゲストレルの有効性と安全性を比較する.
- 保護されていない性行為から72時間以内に,ウリプリスタルアセテートとレボノルゲストレルの非劣等性を評価する.
主な方法:
- ランダム化され,多センターの非劣等性試験で,緊急避妊を希望する2221人の女性が参加しました.
- 参加者は,30mgのウリプリスタルアセテート (n=1104) または1.5mgのレボノルゲストレル (n=1117) の単一の経口投与を受けた.
- 効果をさらに評価するために,現在の試験と以前の研究のメタ分析が行われました.
主要な成果:
- 72時間以内に,妊娠率はulipristal acetateで1.8% (15/844) とlevonorgestrelで2.6% (22/852) であった (OR 0.68,95%CI 0.35-1.31).
- 72~120時間の間に,3人の妊娠が起きましたが,すべてレボノルゲストレル群です.
- メタアナリシス (0-72h) は,ウリプリスタルアセテート (1.4%) とレボノルゲストレル (2.2%; OR 0.58, p=0.046) の妊娠率が著しく低いことを示しました.
- 頭痛は最も頻繁に発生する有害事象であり,両方のグループで同様の発生率を示した.
結論:
- ウリプリスタルアセテートは,緊急避妊の安全で効果的な代替品です.
- 無防備の性行為から最大5日後に効果的に使用することができ,より広い治療窓を提供します.
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