イソニアジドと抗レトロウイルス治療を併用して結核を予防する:ランダム化,二重盲検,プラセボ対照試験
Molebogeng X Rangaka1, Robert J Wilkinson2, Andrew Boulle3
1Centre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa; Clinical Infectious Disease Research Initiative, Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa; London School of Hygiene & Tropical Medicine, London, UK.
Lancet (London, England)
|May 20, 2014
まとめ
イソニアジドによる予防治療は,抗レトロウイルス治療を受けているHIV-1患者で結核のリスクを有意に低下させた. この利点は,結核素皮膚検査やインターフェロンガンマ放出試験の結果に関係なく観察され,その広範な勧告を支持しました.
科学分野:
- 感染症 感染症は感染症です.
- 公衆衛生は公衆衛生である.
- クリニック・トライアル 臨床試験
背景:
- 結核 (TB) は,抗レトロウイルス療法 (ART) にかかわらず,HIV感染者において一般人よりもより多い.
- イソニアジドによる予防療法 (IPT) は,結核の発生率を減らすための重要な戦略です.
研究 の 目的:
- 同時期に抗レトロウイルス治療を受けているHIV-1感染者における結核のリスクを低減するためのイソニアジド予防療法の有効性を評価する.
主な方法:
- プラグマティック,ランダム化,ダブルブラインド,プラセボ対照試験は,南アフリカのカイリシュタで行われました.
- 1329人の参加者は,IPTの12ヶ月またはプラセボを受けるように割り当てられました.
- 主要エンドポイントは,結核発症の発生までの時間であり,治療意図分析が修正されました.
主要な成果:
- IPTで結核の発生率が37%減少した (100人年当たり3.6例),プラセボと比較して (100人年当たり2.3例),危険比率は0.63 (95%CI 0.41-0.94) であった.
- IPTの有効性は,ベースラインの結核素皮膚検査またはインターフェロンガンマ放出アッセイの状態に関係なく,参加者間で一貫していました.
- グレード3または4のアラニントランスアミナーゼ上昇は,IPT群の2.9%とプラセボ群の1.5%で試験薬の中止につながりました.
結論:
- イソニアジドによる予防治療は,中等から高い結核発症率のある地域において,抗レトロウイルス治療を受けているすべての患者に推奨されます.
- 推薦は,結核素皮膚検査またはインターフェロンガンマ放出検査の状態に関係なく,より予測的な診断ツールがない場合に推奨されます.
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