Uretsky B F, Young J B, Shahidi F E, Yellen L G, Harrison M C, Jolly M K
Presbyterian University Hospital, Pittsburgh, Pennsylvania 15213.
J Am Coll Cardiol. 1993 Oct;22(4):955-62. doi: 10.1016/0735-1097(93)90403-n.
The purpose of this study was to determine whether digoxin is effective in patients with chronic, stable mild to moderate heart failure.
Digoxin has been a traditional therapy in heart failure, but methodologic limitations in earlier studies have prevented definitive conclusions regarding its efficacy.
Withdrawal of digoxin (placebo group, n = 46) or its continuation (digoxin group, n = 42) was performed in a prospective, randomized, double-blind, placebo-controlled multicenter trial of patients with chronic, stable mild to moderate heart failure secondary to left ventricular systolic dysfunction who had normal sinus rhythm and were receiving long-term treatment with diuretic drugs and digoxin.
Patients withdrawn from digoxin therapy showed worsened maximal exercise capacity (median change in exercise time -96 s) compared with that of patients who continued to receive digoxin (change in exercise time +4.5 s) (p = 0.003). Patients withdrawn from digoxin therapy showed an increased incidence of treatment failures (p = 0.039) (39%, digoxin withdrawal group vs. 19%, digoxin maintenance group) and a decreased time to treatment failure (p = 0.037). In addition, patients who continued to receive digoxin had a lower body weight (p = 0.044) and heart rate (p = 0.003) and a higher left ventricular ejection fraction (p = 0.016).
These data provide strong evidence of the clinical efficacy of digoxin in patients with normal sinus rhythm and mild to moderate chronic heart failure secondary to systolic dysfunction who are treated with diuretics.
本研究旨在确定地高辛对慢性稳定型轻至中度心力衰竭患者是否有效。
地高辛一直是心力衰竭的传统治疗药物，但早期研究中的方法学局限性阻碍了就其疗效得出明确结论。
在一项前瞻性、随机、双盲、安慰剂对照的多中心试验中，对因左心室收缩功能障碍导致慢性稳定型轻至中度心力衰竭、窦性心律正常且正在接受利尿剂和地高辛长期治疗的患者，进行了地高辛撤药（安慰剂组，n = 46）或继续用药（地高辛组，n = 42）的操作。
与继续接受地高辛治疗的患者相比，停用洋地黄治疗的患者最大运动能力恶化（运动时间中位数变化为 -96 秒）（运动时间变化为 +4.5 秒）（p = 0.003）。停用洋地黄治疗的患者治疗失败发生率增加（p = 0.039）（地高辛撤药组为 39%，地高辛维持组为 19%），治疗失败时间缩短（p = 0.037）。此外，继续接受地高辛治疗的患者体重较低（p = 0.044）、心率较低（p = 0.003）且左心室射血分数较高（p = 0.016）。
这些数据有力地证明了地高辛对窦性心律正常且因收缩功能障碍导致轻至中度慢性心力衰竭并接受利尿剂治疗的患者具有临床疗效。
