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氟卡尼与维拉帕米治疗阵发性室上性心动过速的随机对照研究。氟卡尼多中心研究组。

A randomized comparison of flecainide versus verapamil in paroxysmal supraventricular tachycardia. The Flecainide Multicenter Investigators Group.

作者信息

Dorian P, Naccarelli G V, Coumel P, Hohnloser S H, Maser M J

机构信息

St. Michael's Hospital, University of Toronto, Ontario, Canada.

出版信息

Am J Cardiol. 1996 Jan 25;77(3):89A-95A. doi: 10.1016/s0002-9149(97)89123-0.

Abstract

Reentrant paroxysmal supraventricular tachycardia (PSVT) are frequently encountered in clinical practice. Verapamil and flecainide have both been successfully used as chronic oral therapy to prevent PSVT recurrences. This open-label, randomized, multicenter study was designed to compare the efficacy and adverse effects of verapamil (median dose, 240 mg/day) versus flecainide (median dose, 200 mg/day) in patients with frequent and symptomatic attacks of PSVT (other than atrial fibrillation or flutter). A total of 121 patients receiving flecainide (n = 63) or verapamil (n = 58) were followed for 8.1 +/- 5.1 and 7.5 +/- 5.4 months, respectively. Response was judged clinically as effective or not by the treating physician. By life table analysis, 11% discontinued flecainide and 19% discontinued verapamil for inefficacy at 1 year (difference not significant). Both groups showed a marked reduction in the frequency of attacks of PSVT. Before therapy, 71% of flecainide patients and 73% of verapamil patients had > or = 2 attacks per month. During therapy, 86% of all flecainide patient-months and 73% of all verapamil patient-months occurred with 0 or 1 attack; 19 (30%) patients on flecainide completed the trial ( > 270 days) without symptomatic attacks versus 7 (13%) of the patients on verapamil (p = 0.026). Both drugs were well tolerated; 19% of the flecainide group discontinued primarily because of adverse effects, compared with 24% discontinuing verapamil for this reason (difference not significant). Both flecainide and verapamil are effective and well tolerated for the prevention of recurrences of PSVT. For patients in whom radiofrequency ablation procedures cannot be performed or are not indicated, either therapy is a reasonable choice for long-term prophylaxis.

摘要

折返性阵发性室上性心动过速(PSVT)在临床实践中经常遇到。维拉帕米和氟卡尼都已成功用作慢性口服疗法来预防PSVT复发。这项开放标签、随机、多中心研究旨在比较维拉帕米(中位剂量,240毫克/天)与氟卡尼(中位剂量,200毫克/天)对频繁发作且有症状的PSVT(非房颤或房扑)患者的疗效和不良反应。总共121例接受氟卡尼(n = 63)或维拉帕米(n = 58)治疗的患者分别随访了8.1±5.1个月和7.5±5.4个月。治疗医生根据临床判断反应是否有效。通过生命表分析,1年时因无效而停用氟卡尼的患者为11%,停用维拉帕米的患者为19%(差异无统计学意义)。两组PSVT发作频率均显著降低。治疗前,71%的氟卡尼患者和73%的维拉帕米患者每月发作≥2次。治疗期间,所有氟卡尼患者月数的86%和所有维拉帕米患者月数的73%发作0次或1次;19例(30%)服用氟卡尼的患者完成试验(>270天)且无症状发作,而服用维拉帕米的患者为7例(13%)(p = 0.026)。两种药物耐受性良好;氟卡尼组19%的患者主要因不良反应停药,相比之下,维拉帕米组因该原因停药的患者为24%(差异无统计学意义)。氟卡尼和维拉帕米在预防PSVT复发方面均有效且耐受性良好。对于无法进行或不适合进行射频消融手术的患者,两种疗法都是长期预防的合理选择。

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