Singh S N, Fletcher R D, Fisher S G, Singh B N, Lewis H D, Deedwania P C, Massie B M, Colling C, Lazzeri D
Department of Cardiology, Veterans Affairs Medical Center, Washington, D.C. 20422, USA.
N Engl J Med. 1995 Jul 13;333(2):77-82. doi: 10.1056/NEJM199507133330201.
Asymptomatic ventricular arrhythmias in patients with congestive heart failure are associated with increased rates of overall mortality and sudden death. Amiodarone is now used widely to prevent ventricular tachycardia and fibrillation. We conducted a trial to determine whether amiodarone can reduce overall mortality in patients with congestive heart failure and asymptomatic ventricular arrhythmias.
We used a double-blind, placebo-controlled protocol in which 674 patients with symptoms of congestive heart failure, cardiac enlargement, 10 or more premature ventricular contractions per hour, and a left ventricular ejection fraction of 40 percent or less were randomly assigned to receive amiodarone (336 patients) or placebo (338 patients). The primary end point was overall mortality, and the median follow-up was 45 months (range, 0 to 54).
There was no significant difference in overall mortality between the two treatment groups (P = 0.6). The two-year actuarial survival rate was 69.4 percent (95 percent confidence interval, 64.2 to 74.6) for the patients in the amiodarone group and 70.8 percent (95 percent confidence interval, 65.7 to 75.9) for those in the placebo group. At two years, the rate of sudden death was 15 percent in the amiodarone group and 19 percent in the placebo group (P = 0.43). There was a trend toward a reduction in overall mortality among the patients with nonischemic cardiomyopathy who received amiodarone (P = 0.07). Amiodarone was significantly more effective in suppressing ventricular arrhythmias and increased the left ventricular ejection fraction by 42 percent at two years.
Although amiodarone was effective in suppressing ventricular arrhythmias and improving ventricular function, it did not reduce the incidence of sudden death or prolong survival among patients with heart failure, except for a trend toward reduced mortality among those with nonischemic cardiomyopathy.
充血性心力衰竭患者的无症状室性心律失常与总死亡率和猝死率增加相关。胺碘酮目前被广泛用于预防室性心动过速和颤动。我们进行了一项试验，以确定胺碘酮是否能降低充血性心力衰竭和无症状室性心律失常患者的总死亡率。
我们采用双盲、安慰剂对照方案，将674例有充血性心力衰竭症状、心脏扩大、每小时有10次或更多室性早搏且左心室射血分数为40%或更低的患者随机分为接受胺碘酮治疗组（336例患者）或安慰剂组（338例患者）。主要终点是总死亡率，中位随访时间为45个月（范围为0至54个月）。
两个治疗组的总死亡率无显著差异（P = 0.6）。胺碘酮组患者的两年精算生存率为69.4%（95%置信区间为64.2%至74.6%），安慰剂组为70.8%（95%置信区间为65.7%至75.9%）。两年时，胺碘酮组的猝死率为15%，安慰剂组为19%（P = 0.43）。接受胺碘酮治疗的非缺血性心肌病患者的总死亡率有降低趋势（P = 0.07）。胺碘酮在抑制室性心律失常方面显著更有效，且两年时左心室射血分数增加了42%。
尽管胺碘酮在抑制室性心律失常和改善心室功能方面有效，但它并未降低心力衰竭患者的猝死发生率或延长生存期，不过非缺血性心肌病患者的死亡率有降低趋势。
