Hamer A W, Arkles L B, Johns J A
Department of Cardiology, Repatriation General Hospital, Heidelberg, Victoria, Australia.
J Am Coll Cardiol. 1989 Dec;14(7):1768-74. doi: 10.1016/0735-1097(89)90030-2.
The effects of amiodarone in a low dosage (200 mg every 8 h for 2 weeks, then 200 mg/day) was assessed in a double-blind placebo-controlled trial in 34 patients with a history of severe congestive heart failure but no sustained ventricular arrhythmia. Left ventricular ejection fraction, treadmill exercise tolerance and 48 h electrocardiographic monitoring were assessed before and repeatedly after beginning amiodarone or placebo therapy over 6 months, and side effects were monitored. In patients receiving amiodarone, the ejection fraction increased significantly from 19 +/- 7 to 29 +/- 15% at 6 months (p less than 0.01 from baseline), but not significantly in 14 placebo-treated patients (18 +/- 5 to 22 +/- 9%). Exercise tolerance increased significantly in amiodarone-treated patients (median 433 s to 907 s, p less than 0.05), but not significantly in placebo-treated patients (757 to 918 s). Nonsustained ventricular tachycardia was present in 88% of amiodarone-treated patients before, but in only 21% of patients after 6 months of treatment (p = 0.06); it was seen in 43% of placebo-treated patients at baseline and in 50% after 6 months. Fifty percent of amiodarone-treated patients had side effects (principally nausea) and the drug was withdrawn in 28% of cases; no life-threatening effects were seen. Low dose amiodarone appears to have a multifaceted potential to produce benefits in arrhythmia control, exercise tolerance and ventricular function in patients with a history of severe congestive heart failure, but better control of side effects (principally nausea) appears essential. Effects on mortality could not be determined from this study; such assessment requires a larger cohort of patients.
在一项双盲安慰剂对照试验中，对34例有严重充血性心力衰竭病史但无持续性室性心律失常的患者评估了低剂量胺碘酮（每8小时200毫克，持续2周，然后每天200毫克）的效果。在开始胺碘酮或安慰剂治疗前及治疗6个月期间多次评估左心室射血分数、跑步机运动耐量和48小时心电图监测情况，并监测副作用。接受胺碘酮治疗的患者，6个月时射血分数从19±7显著增加至29±15%（与基线相比p<0.01），而14例接受安慰剂治疗的患者射血分数增加不显著（从18±5至22±9%）。胺碘酮治疗的患者运动耐量显著增加（中位数从433秒增至907秒，p<0.05），而安慰剂治疗的患者运动耐量增加不显著（从757秒至918秒）。胺碘酮治疗的患者中88%在治疗前有非持续性室性心动过速，但治疗6个月后仅21%的患者有非持续性室性心动过速（p=0.06）；安慰剂治疗的患者在基线时43%有非持续性室性心动过速，6个月后50%有非持续性室性心动过速。50%接受胺碘酮治疗的患者有副作用（主要是恶心），28%的病例停用了该药物；未观察到危及生命的影响。低剂量胺碘酮似乎在控制心律失常、运动耐量和心室功能方面对有严重充血性心力衰竭病史的患者有多方面的潜在益处，但更好地控制副作用（主要是恶心）似乎至关重要。本研究无法确定对死亡率的影响；此类评估需要更大规模的患者队列。
