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醋酸氟卡尼可预防有症状的阵发性室上性心动过速复发。氟卡尼室上性心动过速研究小组。

Flecainide acetate prevents recurrence of symptomatic paroxysmal supraventricular tachycardia. The Flecainide Supraventricular Tachycardia Study Group.

作者信息

Henthorn R W, Waldo A L, Anderson J L, Gilbert E M, Alpert B L, Bhandari A K, Hawkinson R W, Pritchett E L

机构信息

Division of Cardiology, Christ Hospital, Cincinnati, Ohio 45219.

出版信息

Circulation. 1991 Jan;83(1):119-25. doi: 10.1161/01.cir.83.1.119.

Abstract

Oral flecainide acetate was administered to 34 patients with documented symptomatic paroxysmal supraventricular tachycardia (PSVT) with a double-blind, placebo-controlled, 8-week crossover trial design. PSVT was defined as a regular tachycardia of at least 120 beats/min without evidence of atrioventricular dissociation. The study required considerable patient cooperation. Patients first entered a 4-week qualifying phase followed by a 3-week, open label, flecainide dose-ranging phase. They were then randomized in a blind fashion to receive either placebo or tolerated flecainide dose for an 8-week treatment period and then crossed over after four symptomatic documented episodes of PSVT or at the end of the treatment period. By all efficacy parameters analyzed, flecainide was superior to placebo. Flecainide was associated with an actuarial 79% freedom from symptomatic PSVT events compared with only 15% on placebo at 60 days (p less than 0.001). Of the 34 patients, 29 had recurrence of symptomatic PSVT at least once during the placebo phase; only eight patients had a recurrence during the flecainide phase (p less than 0.001). The median time to the first symptomatic PSVT event was 11 days in the placebo group and greater than 55 days in the flecainide group (p less than 0.001). Likewise, the interval between attacks was a median of 12 days on placebo compared with more than 55 days on flecainide (p less than 0.001). Finally, the flecainide slowed symptomatic PSVT heart rates to 143 +/- 12 beats/min from 178 +/- 12 on placebo (p less than 0.02) in the seven patients who had events in the placebo and flecainide treatment phases.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

采用双盲、安慰剂对照、为期8周的交叉试验设计,对34例有症状性阵发性室上性心动过速(PSVT)记录的患者给予口服醋酸氟卡尼。PSVT定义为至少120次/分钟的规则性心动过速,且无房室分离证据。该研究需要患者大量配合。患者首先进入为期4周的资格期,随后是为期3周的开放标签氟卡尼剂量调整期。然后他们以盲法随机分组,在8周的治疗期接受安慰剂或可耐受的氟卡尼剂量,在记录到4次有症状的PSVT发作后或治疗期结束后进行交叉。通过分析的所有疗效参数,氟卡尼优于安慰剂。在60天时,氟卡尼组有79%的患者无有症状的PSVT事件发生,而安慰剂组仅为15%(p<0.001)。34例患者中,29例在安慰剂阶段至少有一次有症状性PSVT复发;氟卡尼阶段只有8例患者复发(p<0.001)。安慰剂组首次出现有症状性PSVT事件的中位时间为11天,氟卡尼组大于55天(p<0.001)。同样,安慰剂组发作间隔的中位数为12天,氟卡尼组超过55天(p<0.001)。最后,在安慰剂和氟卡尼治疗阶段出现事件的7例患者中,氟卡尼使有症状性PSVT心率从安慰剂组的178±12次/分钟降至143±12次/分钟(p<0.02)。(摘要截断于250字)

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