Prospective, double-blind, placebo-controlled trial of low-dose amiodarone in patients with severe heart failure and asymptomatic frequent ventricular ectopy.
Prospective, double-blind, placebo-controlled trial of low-dose amiodarone in patients with severe heart failure and asymptomatic frequent ventricular ectopy.
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对患有严重心力衰竭和无症状频繁心室异位的患者进行低剂量胺碘酮的前瞻性、双盲、安慰剂对照试验。
DOI：
10.1016/0002-8703(91)90466-u
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发表时间：
1991
影响因子：
4.8
通讯作者：
Pitt,B
中科院分区：
文献类型：
--
作者：
Nicklas,JM;McKenna,WJ;Stewart,RA;Mickelson,JK;Das,SK;Schork,MA;Krikler,SJ;Quain,LA;Morady,F;Pitt,B
心源性猝死是充血性心力衰竭患者死亡的常见原因。为了确定小剂量胺碘酮是否可以减少这些患者的猝死，进行了一项前瞻性、安慰剂对照、双盲试验。101例射血分数<30%、纽约心脏协会III或IV级症状、频繁但无症状的自发性心室异位（Lown II至V级）的患者被随机分配到低剂量胺碘酮（400 mg/天，持续4周，然后200 mg/天）或安慰剂组。平均随访时间为357天（范围4 - 1009天）。副作用不常见，治疗组之间的副作用发生率没有差异。胺碘酮组的自发性心室异位频率从基线时的4992 ± 1240次/24小时降至治疗1个月后的1135 ± 494次/24小时（p= 0.02），并在6个月后保持较低水平，而安慰剂组患者的心室异位没有变化。尽管异位减少，但死亡率没有改善或猝死发生率没有降低。通过Kaplan-Meier分析，胺碘酮组的1年死亡率为28%，安慰剂组为19%（p= NS）。治疗1个月后，心室异位减少>75%的患者的1年死亡率为31%，而异位抑制≤75%的患者的1年死亡率为17%（p= NS）。尽管试验的规模及其统计功效并不能排除低剂量胺碘酮显著降低死亡率的可能性，但任何效果都可能是适度的，即，<25%。因此，小剂量胺碘酮可以安全地用于严重心肌功能受损的患者，并将显著抑制自发性心室异位。然而，尽管有心律失常抑制作用，低剂量胺碘酮可能不会降低或可能仅对心力衰竭和无症状性心室异位患者的猝死发生率有适度影响。
Sudden cardiac death is a common cause of mortality in patients with congestive heart failure. To determine if low-dose amiodarone could reduce sudden death among these patients, a prospective, placebo-controlled, double-blind pilot trial was conducted. One hundred one patients with ejection fractions <30%, New York Heart Association class III or IV symptoms, and frequent but asymptomatic spontaneous ventricular ectopy (Lown class II to V) were randomly assigned to treatment with low-dose amiodarone (400 mg/day for 4 weeks and then 200 mg/day) or placebo. Mean follow-up was 357 days (range 4 to 1009 days). Side effects were infrequent and there was no difference in the incidence of side effects between the treatment groups. The frequency of spontaneous ventricular ectopy in the group receiving amiodarone fell from 4992 ± 1240 beats/24 hours at baseline to 1135 ± 494 beats/24 hours after 1 month of treatment (p= 0.02) and remained low after 6 months, while there was no change in ventricular ectopy among the patients receiving placebo. Despite the reduction in ectopy, there was no improvement in mortality or decrease in the incidence of sudden death. One-year mortality by Kaplan-Meier analysis was 28% in the group receiving amiodarone and 19% in the group receiving placebo (p= NS). One-year mortality in patients with >75% reduction in ventricular ectopy after 1 month of treatment was 31% versus 17% in patients with ≤75% ectopic suppression (p= NS). Although the size of the trial and its statistical power do not eliminate the possibility of a significant reduction in mortality with low-dose amiodarone, any effect is likely to be modest, i.e., <25%. Therefore low-dose amiodarone can be safely administered to patients with severely impaired myocardial function and will significantly suppress spontaneous ventricular ectopy. However, despite arrhythmia suppression, low-dose amiodarone may not reduce or may have only a modest effect on the incidence of sudden death in patients with heart failure and asymptomatic ventricular ectopy.