The effect of spironolactone on morbidity and mortality in patients with severe heart failure
The effect of spironolactone on morbidity and mortality in patients with severe heart failure
复制标题
DOI：
10.1056/nejm199909023411001
复制
发表时间：
1999-09-02
影响因子：
158.5
通讯作者：
Wittes, J
中科院分区：
文献类型：
--
作者：
Pitt, B;Zannad, F;Wittes, J
背景与方法
醛固酮在心力衰竭的病理生理学中具有重要作用。在一项双盲研究中，我们纳入了1663例患有严重心力衰竭且左心室射血分数不超过35%的患者，这些患者正在接受血管紧张素转换酶抑制剂、袢利尿剂治疗，大多数还接受地高辛治疗。共有822例患者被随机分配接受每日25mg螺内酯治疗，841例接受安慰剂。主要终点是全因死亡。
结果
在平均随访24个月后，该试验提前终止，因为一项中期分析确定螺内酯是有效的。安慰剂组有386例死亡（46%），螺内酯组有284例死亡（35%；死亡相对风险为0.70；95%置信区间为0.60 - 0.82；P<0.001）。（最后一个P后面似乎内容不完整）
Background and Methods Aldosterone is important in the pathophysiology of heart failure, In a double-blind study, we enrolled 1663 patients who had severe heart failure and a left ventricular ejection fraction of no more than 35 percent and who were being treated with an a agiotensin-converting-enzyme inhibitor, a loop diuretic, and in most cases digoxin. A total of 822 patients were randomly assigned to receive 25 mg of spironolactone daily, and 841 to receive placebo. The primary end point was death from all causes.Results The trial was discontinued early, after a mean follow-up period of 24 months, because an interim analysis determined that spironolactone was efficacious, There were 386 deaths in the placebo group (46 percent) and 284 in the spironolactone group (35 percent; relative risk of death, 0.70; 95 percent confidence interval, 0.60 to 0.82; P