リウマチ性関節炎におけるセレコキシブの抗炎症性および上部胃腸作用:ランダム化制御試験

L S Simon¹, A L Weaver, D Y Graham

¹Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass 02215, USA.

JAMA

|December 2, 1999

まとめ

セレコキシブは,ナプロクセンよりも少ない胃腸潰瘍で,リウマチ性関節炎の症状を効果的に治療します. このCOX-2阻害剤は,COX-1に関連する胃損傷を大きくすることなく,抗炎症的な効果を提供します.

科学分野:

リーマトロジーの病理学
薬理学薬理学とは
胃腸内科胃腸内科

背景:

実験室内研究では,セレコキシブ (COX-2阻害剤) が,非ステロイド性抗炎症薬 (NSAIDs) に比べて,消化器系 (GI) のリスクを軽減した抗炎症および鎮痛効果をもたらす可能性があることが示唆されています.
NSAIDは伝統的にCOX-1とCOX-2の両方を阻害し,COX-1の阻害による潜在的な上部GIの有害効果につながります.

研究の目的:

リウマチ性関節炎患者の抗炎症および鎮痛剤としてのセレコキシブの有効性を評価する.
セレコキシブが,従来のNSAIDと比較して,消化器官粘膜の損傷を少なくするかどうかを評価する.

主な方法:

12週間のランダム化,マルチセンター,プラセボ対照,ダブルブラインド試験で,リウマチ性関節炎の患者1,149人が参加しました.
患者はセレコキシブ (100,200,または400 mg BID),ナプロキセン (500 mg BID),またはプラセボを受けた.
効果は標準的な関節炎症状評価で測定され,胃腸内視鏡検査で胃腸安全性が評価されました.

主要な成果:

セレコキシブとナプロキセンは,プラセボと比較して,関節リウマチの徴候と症状を著しく改善し,12週間にわたって効果が持続しました.
ガストロドゥオデナル潰瘍の発生率は,セレコキシブ (4-6%) またはプラセボ (4%) で治療された患者でナプロクセン (26%) と比較して有意に低かった.
総合的なGI有害事象の発生率はセレコキシブ (25-28%) とプラセボ (19%) の間で比較可能だったが,ナプロクセン (31%) の場合はより高かった.

結論:

セレコキシブは,試験されたすべての用量において,リウマチ性関節炎の治療に有効性を示しました.
この研究では,セレコキシブはナプロクセンと比較して内視鏡性潰瘍の発生率が低いことを確認し,消化器官粘膜のCOX-1活性が保存されていることを示唆しました.

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