口服普罗帕酮转复近期发作房颤为窦性心律的安全性：一项前瞻性平行安慰剂对照多中心研究。

Safety of oral propafenone in the conversion of recent onset atrial fibrillation to sinus rhythm: a prospective parallel placebo-controlled multicentre study.

作者信息

Capucci A, Villani G Q, Aschieri D, Piepoli M

机构信息

Department of Cardiology, General Hospital, Piacenza, Italy.

出版信息

Int J Cardiol. 1999 Feb 28;68(2):187-96. doi: 10.1016/s0167-5273(98)00363-5.

DOI:10.1016/s0167-5273(98)00363-5

PMID:10189007

Abstract

AIM

Oral propafenone is effective in restoring sinus rhythm however the proarrhythmic effects are still unknown. The Safety Antiarrhythmic Therapy Evaluation (SATE) trial was a prospective randomized placebo-controlled multicentre study which evaluated the safety of acute oral loading dose of propafenone in patients with recent onset atrial fibrillation. Secondary end-points were to evaluate the effect of digitalis added to propafenone in ventricular rate control and the efficacy of propafenone alone or added to digitalis compared with efficacy of digitalis plus quinidine.

METHODS AND RESULTS

246 patients (126 male; 58+/-11 years) with atrial fibrillation of <48 h duration were randomly allocated to one of four groups: digitalis 0.75-1 mg i.v. plus quinidine 1100 mg (D+Q, 70 patients); propafenone 450-600 mg orally (PNF, 66 patients); propafenone 450-600 mg orally plus digitalis 0.750-1 mg i.v. (PNF+D, 70 patients); placebo (Pl, 40 patients). All patients underwent 24-h ECG Holter monitoring. Safety was assessed by evaluating the appearance of adverse events classified as mild, moderate and severe. No severe adverse events were reported. Short lasting asymptomatic atrial flutter episodes with atrio-ventricular conduction > or =2:1 were observed in 14% of the D+Q group, 21% PNF, 18% PNF+D and in 8% Pl. One patient in the D+Q group and four in the PNF+D group showed asymptomatic runs of 3-4 ventricular ectopic beats. Reversible sinus atrial blocks (<3 s) were detected in two patients of the D+Q group and in two of the PNF group. In patients with persistent atrial fibrillation the ventricular rate was similar in the four study groups. At 3 h the high efficacy of propafenone was confirmed. At the 24th hour no differences were found between active treatment and placebo arms.

CONCLUSION

Propafenone in a single oral loading dose is safe and promptly effective in patients with recent onset atrial fibrillation.

摘要

目的

口服普罗帕酮对恢复窦性心律有效，但致心律失常作用仍不明确。安全性抗心律失常治疗评估（SATE）试验是一项前瞻性随机安慰剂对照多中心研究，评估近期发作房颤患者口服普罗帕酮急性负荷剂量的安全性。次要终点是评估普罗帕酮加用洋地黄对心室率控制的效果，以及普罗帕酮单独使用或加用洋地黄与洋地黄加奎尼丁疗效的比较。

方法与结果

246例（126例男性；年龄58±11岁）房颤持续时间<48小时的患者被随机分为四组之一：静脉注射洋地黄0.75 - 1毫克加奎尼丁1100毫克（D + Q组，70例患者）；口服普罗帕酮450 - 600毫克（PNF组，66例患者）；口服普罗帕酮450 - 600毫克加静脉注射洋地黄0.750 - 1毫克（PNF + D组，70例患者）；安慰剂（Pl组，40例患者）。所有患者均接受24小时动态心电图监测。通过评估分类为轻度、中度和重度的不良事件的出现情况来评估安全性。未报告严重不良事件。D + Q组14%、PNF组21%、PNF + D组18%和Pl组8%观察到短暂无症状性心房扑动发作伴房室传导≥2:1。D + Q组1例患者和PNF + D组4例患者出现无症状性3 - 4次室性早搏。D + Q组2例患者和PNF组2例患者检测到可逆性窦房阻滞（<3秒）。在持续性房颤患者中，四个研究组的心室率相似。3小时时证实了普罗帕酮的高效性。24小时时，活性治疗组与安慰剂组之间未发现差异。