氟卡尼与索他洛尔预防阵发性心房颤动复发的比较

[A comparison between flecainide and sotalol in the prevention of recurrences of paroxysmal atrial fibrillation].

作者信息

Carunchio A, Fera M S, Mazza A, Burattini M, Greco G, Galati A, Ceci V

机构信息

Servizio di Cardiologia ed UTIC, Ospedale S. Spirito, Roma.

出版信息

G Ital Cardiol. 1995 Jan;25(1):51-68.

PMID:7642012

Abstract

OBJECTIVES

Aim of the present study was to assess the efficacy and safety of flecainide (F) and sotalol (S) for the prevention of recurrences of paroxysmal atrial fibrillation (PAF).

METHODS

Sixty-six patients with PAF (> or = 3 episodes of atrial fibrillation in the last year) in sinus rhythm, were randomized to pharmacological oral treatment with F (20 patients-Group A), with S (20 patients-Group B) and placebo (P) (26 patients-Group C). During the follow-up (one year duration) were evaluated on I, III, VI and XII months the number and tolerance of the atrial fibrillation recurrences, cardiac and/or noncardiac side effects. The patients with more than two recurrences in the same follow-up interval withdrew from the study. In each patient 14 clinical and laboratory variables were evaluated.

RESULTS

After 12 months were arrhythmia-free respectively 70% of Group A patients, 60% of Group B patients, 27% of Group C patients. Univariate analysis showed that treatment with F was related to decrease of atrial fibrillation recurrences (one recurrence 67%, two recurrences 81%, three recurrences 81%), treatment with S was related to decrease of recurrences (two recurrences 59%); the variable most significantly related to the risk of arrhythmia recurrence is the higher value of basal cardiac rate (one recurrence t = 2.15, two t = 2.22, three t = 2.96, four t = 2.06). There was not statistically significant difference in maintenance of sinus rhythm at the end of the follow-up between the groups of patients on F and S (p = 0.163); treatment efficacy was significantly higher than P (p = 0.002). Multivariate analysis showed that treatment with F and S decreases the risk of arrhythmia recurrence respectively of 85% and 76% versus placebo at the end of the follow-up. The incidence of cardiac and/or noncardiac side effects was not clinically significant.

CONCLUSION

F and S are both effective and safe for prevention of PAF, with 70% and 60% respectively of patients arrhythmia-free after 12 months of treatment. Side effects were common, but clinically significant adverse events were uncommon. A higher value of basal cardiac rate was predictive of atrial fibrillation recurrences in the patients during treatment.

摘要

目的

本研究旨在评估氟卡尼（F）和索他洛尔（S）预防阵发性心房颤动（PAF）复发的疗效和安全性。

方法

66例处于窦性心律的PAF患者（过去一年心房颤动发作≥3次），被随机分为接受F口服药物治疗组（20例，A组）、S口服药物治疗组（20例，B组）和安慰剂组（P，26例，C组）。在随访期间（为期一年），在第1、3、6和12个月评估心房颤动复发的次数和耐受性、心脏和/或非心脏副作用。在同一随访间隔内复发超过两次的患者退出研究。对每位患者评估14项临床和实验室变量。

结果

12个月后，A组患者无心律失常的比例为70%，B组为60%，C组为27%。单因素分析显示，F治疗与心房颤动复发减少相关（1次复发67%，2次复发81%，3次复发81%），S治疗与复发减少相关（2次复发59%）；与心律失常复发风险最显著相关的变量是基础心率较高（1次复发t = 2.15，2次t = 2.22，3次t = 2.96，4次t = 2.06）。在随访结束时，F组和S组患者维持窦性心律方面无统计学显著差异（p = 0.163）；治疗疗效显著高于安慰剂组（p = 0.002）。多因素分析显示，随访结束时，与安慰剂相比，F和S治疗分别使心律失常复发风险降低85%和76%。心脏和/或非心脏副作用的发生率无临床意义。