Mount Sinai Medical Center, New York, NY 10029-6574, USA.
N Engl J Med. 1997 Feb 20;336(8):525-33. doi: 10.1056/NEJM199702203360801.
The role of cardiac glycosides in treating patients with chronic heart failure and normal sinus rhythm remains controversial. We studied the effect of digoxin on mortality and hospitalization in a randomized, double-blind clinical trial.
In the main trial, patients with a left ventricular ejection fraction of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and angiotensin-converting-enzyme inhibitors (median dose of digoxin, 0.25 mg per day; average follow-up, 37 months). In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo.
In the main trial, mortality was unaffected. There were 1181 deaths (34.8 percent) with digoxin and 1194 deaths (35.1 percent) with placebo (risk ratio when digoxin was compared with placebo, 0.99; 95 percent confidence interval, 0.91 to 1.07; P=0.80). In the digoxin group, there was a trend toward a decrease in the risk of death attributed to worsening heart failure (risk ratio, 0.88; 95 percent confidence interval, 0.77 to 1.01; P=0.06). There were 6 percent fewer hospitalizations overall in that group than in the placebo group, and fewer patients were hospitalized for worsening heart failure (26.8 percent vs. 34.7 percent; risk ratio, 0.72; 95 percent confidence interval, 0.66 to 0.79; P<0.001). In the ancillary trial, the findings regarding the primary combined outcome of death or hospitalization due to worsening heart failure were consistent with the results of the main trial.
Digoxin did not reduce overall mortality, but it reduced the rate of hospitalization both overall and for worsening heart failure. These findings define more precisely the role of digoxin in the management of chronic heart failure.
强心苷类药物在治疗慢性心力衰竭且窦性心律正常的患者中的作用仍存在争议。我们在一项随机、双盲临床试验中研究了地高辛对死亡率和住院率的影响。
在主要试验中，左心室射血分数为0.45或更低的患者除接受利尿剂和血管紧张素转换酶抑制剂治疗外，被随机分配至地高辛组（3397例患者）或安慰剂组（3403例患者）（地高辛中位剂量为每日0.25毫克；平均随访37个月）。在一项针对射血分数大于0.45的患者的辅助试验中，492例患者被随机分配至地高辛组，496例被分配至安慰剂组。
在主要试验中，死亡率未受影响。地高辛组有1181例死亡（34.8%），安慰剂组有1194例死亡（35.1%）（地高辛与安慰剂相比的风险比为0.99；95%置信区间为0.91至1.07；P = 0.80）。在地高辛组，因心力衰竭恶化导致的死亡风险有降低趋势（风险比为0.88；95%置信区间为0.77至1.01；P = 0.06）。该组总体住院率比安慰剂组少6%，因心力衰竭恶化住院的患者也更少（26.8%对34.7%；风险比为0.72；95%置信区间为0.66至- 0.79；P < 0.001）。在辅助试验中，关于因心力衰竭恶化导致死亡或住院的主要联合结局的研究结果与主要试验结果一致。
地高辛未降低总体死亡率，但降低了总体住院率以及因心力衰竭恶化导致的住院率。这些发现更精确地界定了地高辛在慢性心力衰竭管理中的作用。
