双盲,安慰剂对照试验的迪戈辛在有症状的心脏动症
F D Murgatroyd1, S M Gibson, X Baiyan
1St George's Hospital Medical School, London, UK. fmurgatroyd@compuserve.com
Circulation
|June 3, 1999
概括
迪戈辛略微减少了症状性心房动 (AF) 的发作,可能是通过减缓心率而不是作为抗不律性. 这项研究评估了狄戈辛.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 迪戈辛经常被处方用于症状性心房动 (AF).
- 然而,它在这种特定条件中的有效性尚未先前评估.
- 动性心房动会给患者带来显著的症状负担.
研究的目的:
- 评估狄戈辛在减轻 Paroxysmal 心房的症状发作中的有效性.
- 在一项随机,双盲交叉试验中,将狄戈辛的效果与安慰剂进行比较.
- 评估狄戈辛对心室率和AF发作频率的影响.
主要方法:
- 一项多中心,随机,双盲,交叉研究,涉及43名患有频繁症状性AF发作的患者.
- 患者接受了迪戈辛 (血清度1.29+/-0.35nmol/L) 或安慰剂.
- 主要终点是两个记录的AF发作发生的时间,在61天后进行审查.
主要成果:
- 与安慰剂 (13.5天) (P<0.05) 相比,迪戈辛 (18.7天) 的中位时间到两次AF发作显著更长 (P<0.05).
- 与狄戈辛相比,在安慰剂组中经历两次AF发作的相对风险是安慰剂组的2.19倍.
- 在AF期间的平均腹腔动脉率在狄戈辛 (125+/-35bpm) 与安慰剂 (138+/-32bpm) (P<0.01) 相比较低.
结论:
- 迪戈辛表明,症状性心房的发作频率在统计学上显著降低.
- 观察到的效果大小很小,这表明潜在的好处可能来自心室节拍控制或减少不规则.
- 在这种情况下,digoxin的主要作用可能不是直接的抗心律失常作用.
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