普罗帕酮口服负荷给药：一项针对近期发作房颤的老年和非老年患者的安慰剂对照研究。

Oral loading with propafenone: a placebo-controlled study in elderly and nonelderly patients with recent onset atrial fibrillation.

作者信息

Boriani G, Biffi M, Capucci A, Botto G L, Broffoni T, Rubino I, Della Casa S, Sanguinetti M, Branzi A, Magnani B

机构信息

Institute of Cardiology, University of Bologna, Italy.

出版信息

Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 2):2465-9. doi: 10.1111/j.1540-8159.1998.tb01202.x.

DOI:10.1111/j.1540-8159.1998.tb01202.x

PMID:9825368

Abstract

UNLABELLED

The efficacy and safety of propafenone as an oral loading dose (600-mg single oral dose) in converting recent-onset atrial fibrillation (< or = 7 days duration) to sinus rhythm were evaluated in a single-blind, placebo-controlled study according to patients' age. Overall, 240 hospitalized patients, NYHA Class < or = 2 without signs or symptoms of heart failure were enrolled: among patients aged < or = 60 years, 55 were allocated to propafenone treatment and 59 to placebo, respectively, and among patients aged > 60 years, 64 were allocated to propafenone treatment and 62 to placebo, respectively.

RESULTS

In each age group, the likelihood of conversion to sinus rhythm was significantly greater after propafenone compared with placebo at 3 and 8 hours. For patients aged < or = 60 years, corresponding odd ratios were 3.78 (95% CI = 1.80-7.92, P = 0.04) at 3 hours and 4.74 (95% CI = 2.12-10.54, P = 0.02) at 8 hours; for patients aged > 60 years odd ratios were 5.03 (95% CI = 2.08-12.12, P = 0.02) at 3 hours and 6.75 (95% CI = 3.28-73.86, P = 0.01) at 8 hours, respectively. Logistic regression analysis showed that conversion to sinus rhythm within 3 hours was predicted by age < or = 60 years (P = 0.0064) and by propafenone treatment (P < 0.0001), and conversion to sinus rhythm within 8 hours was predicted by age < or = 60 years (P = 0.0467) and by propafenone treatment (P < 0.0001). The occurrence of adverse effects was observed in 14%-16% of propafenone treated patients and in 8% of placebo treated patients without significant differences according to age. In conclusion, in patients with recent-onset atrial fibrillation without signs of heart failure, propafenone as a single oral loading dose is effective. It is also effective in selected elderly subjects with a favorable safety profile. Moreover, spontaneous conversion to sinus rhythm appears to occur less frequently in elderly patients.

摘要

未标记

在一项单盲、安慰剂对照研究中，根据患者年龄评估了普罗帕酮作为口服负荷剂量（单次口服600毫克）转复近期发作的房颤（持续时间≤7天）为窦性心律的疗效和安全性。总共纳入了240例住院患者，纽约心脏协会心功能分级≤2级且无心力衰竭体征或症状：年龄≤60岁的患者中，分别有55例分配至普罗帕酮治疗组和59例分配至安慰剂组；年龄>60岁的患者中，分别有64例分配至普罗帕酮治疗组和62例分配至安慰剂组。

结果

在每个年龄组中，普罗帕酮治疗后3小时和8小时转复为窦性心律的可能性均显著高于安慰剂组。对于年龄≤60岁的患者，3小时时相应的比值比为3.78（95%置信区间=1.80 - 7.92，P = 0.04），8小时时为4.74（95%置信区间=2.12 - 10.54，P = 0.02）；对于年龄>60岁的患者，3小时时比值比为5.03（95%置信区间=2.08 - 12.12，P = 0.02），8小时时为6.75（95%置信区间=3.28 - 73.86，P = 0.01）。逻辑回归分析显示，3小时内转复为窦性心律可由年龄≤60岁（P = 0.0064）和普罗帕酮治疗（P < 0.0001）预测，8小时内转复为窦性心律可由年龄≤60岁（P = 0.0467）和普罗帕酮治疗（P < 0.0001）预测。普罗帕酮治疗组14% - 16%的患者出现不良反应，安慰剂治疗组8%的患者出现不良反应，按年龄无显著差异。总之，在近期发作的无心力衰竭体征的房颤患者中，普罗帕酮单次口服负荷剂量有效。在选定的安全性良好的老年患者中也有效。此外，老年患者自发转复为窦性心律的情况似乎较少见。