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氟卡尼与西苯唑啉转复心房颤动的随机对照研究

Randomized comparison of flecainide and cibenzoline in the conversion of atrial fibrillation.

作者信息

Kühlkamp V, Schmid F, Risler T, Seipel L

机构信息

Medizinische Klinik Abteilung III, Eberhard-Karls-Universität, Tübingen, F.R.G.

出版信息

Int J Cardiol. 1991 Apr;31(1):65-9. doi: 10.1016/0167-5273(91)90269-u.

Abstract

The efficacy of oral cibenzoline (260 mg/day and 320 mg/day) and flecainide (200 mg/day and 300 mg/day) in the conversion of chronic atrial fibrillation to sinus rhythm were compared in 31 patients in a randomized order. If sinus rhythm was not restored on the 5th day of oral treatment with either cibenzoline or flecainide (phase of initial treatment) patients were switched to a second phase of treatment with the drug not given in the first phase after a washout phase of 3 days. Sinus rhythm was restored in 7/28 treatment trials with cibenzoline and in 7/23 treatment trials with flecainide (not significant). Trough levels of cibenzoline and flecainide in the plasma were not significantly different between patients in whom sinus rhythm was restored and patients with persisting atrial fibrillation. In patients successfully converted to sinus rhythm, long-term treatment was instituted with flecainide (n = 6) or cibenzoline (n = 6). Atrial fibrillation developed in 2 patients in each group of patients within 3 months. In all other patients, sinus rhythm was maintained during the follow-up period of 12 months. Non-cardiac side effects were observed in 2 patients during treatment with cibenzoline and flecainide respectively. With flecainide, one patient developed sinus arrest up to 5.6 seconds.

摘要

对31例患者进行随机分组,比较口服西苯唑啉(260毫克/天和320毫克/天)和氟卡尼(200毫克/天和300毫克/天)将慢性房颤转复为窦性心律的疗效。若在口服西苯唑啉或氟卡尼治疗的第5天(初始治疗阶段)未恢复窦性心律,则在经过3天的洗脱期后,将患者换用第一阶段未使用的药物进入第二阶段治疗。在使用西苯唑啉的28次治疗试验中有7次恢复了窦性心律,在使用氟卡尼的23次治疗试验中有7次恢复了窦性心律(差异无统计学意义)。恢复窦性心律的患者与持续性房颤患者的血浆中西苯唑啉和氟卡尼的谷浓度无显著差异。成功转复为窦性心律的患者,分别采用氟卡尼(n = 6)或西苯唑啉(n = 6)进行长期治疗。每组各有2例患者在3个月内发生房颤。在所有其他患者中,窦性心律在12个月的随访期内得以维持。使用西苯唑啉和氟卡尼治疗期间分别有2例患者出现非心脏性副作用。使用氟卡尼时,有1例患者发生长达5.6秒的窦性停搏。

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