尿中のN-ニトロジメチラミン (NDMA) の分泌に対する口服ラニチドインの効果: ランダム化臨床試験
Jeffry Florian1, Murali K Matta1, Ryan DePalma1
1Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA
|June 28, 2021
まとめ
この研究では,ラニチジンは,固肉食でも尿中のN- ニトロジメチラミン (NDMA) を有意に増加させないことが判明しました. これらの発見は,ラニチジンは健康な個体ではNDMAに変換されないことを示唆しています.
科学分野:
- 薬理学について
- 毒理学について
- 臨床試験の研究
背景:
- ランチチンのN-ニトロジメチアミン (NDMA) 汚染に関する懸念は,規制当局の精査につながった.
- NDMAの分泌を増加させる可能性を示唆し,さらなる調査を促した.
研究 の 目的:
- 経口ラニチジン投与後の24時間の尿中のN- ニトロジメチラミン (NDMA) の分泌量をプラセボと比較する.
- 健康な参加者において,制御された食事条件下で,ラニチジンからNDMAへの潜在的変換を評価する.
主な方法:
- ランダム化され,ダブルブラインド,プラセボ対照のクロスオーバー試験で18人の健康な参加者が参加しました.
- 肉食と肉食の食事の期間中,参加者はラニチジン (300 mg) またはプラセボを受けた.
- NDMAの分泌量を測定するために24時間の尿サンプルを採取した.
主要な成果:
- ランチチジンとプラセボ群の間で24時間の尿によるNDMA分泌の統計的に有意な差は認められなかった.
- これは,固化されていない肉と固化肉の食事条件の両方に当てはまりました.
- 薬物に関連した重大な有害事象は報告されていません.
結論:
- 研究の結果は,ラニチドンが一般の健康な人群でNDMAに変換するという仮説を支持しません.
- ラニチジン (300 mg) は,プラセボと比較して,尿によるNDMA排出量を有意に増加させなかった.
- 特定のサブ集団または異なる条件下でNDMAの形成を調査するためにさらなる研究が必要になる可能性があります.
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