アセトアミノフェンを1日4グラム摂取する健康な成人のアミノトランスフェラーゼ値上昇:ランダム化制御試験
Paul B Watkins1, Neil Kaplowitz, John T Slattery
1Department of Medicine, University of North Carolina, Chapel Hill, USA. pbwatkins@med.unc.edu
JAMA
|July 6, 2006
まとめ
アセトアミノフェンの1日摂取量4グラムは,健康な成人の場合,肝臓酵素上昇 (ALT) を引き起こす可能性があります. アセトアミノフェンとオピオイドの組み合わせは,この効果を増加させず,アセトアミノフェンだけで原因であることを示唆しました.
科学分野:
- 肝臓病理学 肝臓病理学
- 臨床薬理学 臨床薬理学とは
- 毒理学 毒理学 毒理学
背景:
- 臨床試験では,新しいヒドロコドン/アセトアミノフェンの組み合わせで高いアラニンアミノトランスフェラゼ (ALT) 値上昇が認められた.
- これは,肝臓酵素の変化におけるアセトアミノフェンの役割に関する調査を促した.
研究 の 目的:
- アセトアミノフェンを1日4g服用する健康な成人のALT上昇の発生率と重症度を決定する.
- アセトアミノフェンが単独で服用されたときとオピオイドを併用したときにこれらの上昇を比較するために.
- アセトアミノフェン誘発の肝臓酵素変化の基準を確立するために.
主な方法:
- 145人の健康な成人を対象としたランダム化プラセボ対照試験です.
- 参加者はプラセボ,アセトアミノフェン単独 (4g/日),またはアセトアミノフェンとオピオイド (4g/日) を投与された.
- 肝臓の化学反応とアセトアミノフェンのレベルは,毎日モニタリングされました.
主要な成果:
- プラセボ群の参加者は,正常値の上限の3倍以上のALT上昇を示さなかった.
- アセトアミノフェンを1日4g服用した参加者の31%~44%が,ALT値が正常値の上限より3倍以上上昇した.
- アセトアミノフェンの使用は,プラセボと比較して,最大ALTの中央値の2.78倍増加と関連していました.
結論:
- アセトアミノフェンを1日4g服用すると,健康な成人ではALT値が上昇する可能性があります.
- オピオイドの併用は,アセトアミノフェン誘発のALT上昇を悪化させるようには見えない.
- アセトアミノフェンの使用は,血清濃度が検出できない場合でも,ALT値上昇を診断する際に考慮する必要があります.
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