症状性心房細動症候群におけるディゴキシンの二重盲検プラセボ対照試験
F D Murgatroyd1, S M Gibson, X Baiyan
1St George's Hospital Medical School, London, UK. fmurgatroyd@compuserve.com
Circulation
|June 3, 1999
まとめ
ディゴキシンは,抗不律薬として作用するのではなく,潜在的に心拍数を遅らせることで,症状のあるパラキシズマル心房動 (AF) のエピソードをわずかに軽減します. この研究では,ディゴキシンを評価した.
科学分野:
- 心臓病学 心臓病学
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- ディゴキシン (Digoxin) は,症状のある心房細動 (AF) の治療に頻繁に処方されます.
- しかし,この特定の状態での有効性は,以前に評価されていません.
- パロキシズム性心房細動は,患者に重大な症状の負担をもたらします.
研究 の 目的:
- 動性心房動の症状エピソードを軽減するディゴキシンの有効性を評価する.
- ランダム化され,二重盲検のクロスオーバー試験において,プラセボに対するディゴキシンの効果を比較する.
- 静脈回転率とAFエピソード頻度に対するディゴキシンの影響を評価する.
主な方法:
- マルチセンター,ランダム化,ダブルブラインド,クロスオーバー研究で,症状のあるAFエピソードが頻発する43人の患者が参加した.
- 患者はディゴキシン (血清濃度1.29+/-0.35nmol/L) またはプラセボを投与された.
- 主要エンドポイントは,61日後に検閲された2つの文書化されたAFエピソードの発生までの時間でした.
主要な成果:
- 2回のAFエピソードまでの平均時間は,プラセボ (13.5日) と比較してディゴキシン (18.7日) で有意に長かった (P<0.05).
- AFエピソードを2回経験する相対的なリスクは,ディゴキシンと比較してプラセボで2.19倍高かった.
- AF中の心室発作率の平均値は,ディゴキシン (125+/-35 bpm) とプラセボ (138+/-32 bpm) (P<0.01) と比較して低かった.
結論:
- ディゴキシンは,症状のあるパラキシズム性心房動のエピソードの頻度において統計的に有意な減少を示しています.
- 観察された効果の大きさは控えめで,心室速度の制御や不規則性の減少から潜在的な利益が生じることを示唆しています.
- この文脈におけるディゴキシンの主な作用は,直接的な抗リズム効果ではないかもしれません.
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