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短效和缓释奎尼丁治疗室性心律失常患者的疗效和安全性比较

Comparative efficacy and safety of short-acting and sustained release quinidine in the treatment of patients with ventricular arrhythmias.

作者信息

Morganroth J, Hunter H

出版信息

Am Heart J. 1985 Dec;110(6):1176-81. doi: 10.1016/0002-8703(85)90008-0.

Abstract

A comparative, fixed-dose, parallel, randomized, blinded trial to define the efficacy and safety of a new once-a-day quinidine preparation, Quiniday, at 1200 mg per day, was compared to quinidine sulfate (as Quinora, 300 mg four times daily, and Quinidex Extentabs, 600 mg twice daily) and to quinidine gluconate (as Quinaglute Dura-Tabs, 648 mg twice daily). After placebo washout from all prior antiarrhythmic agents, 76 patients with at least 30 ventricular premature complexes (VPCs)/hr on 48-hour ambulatory monitoring were randomized to 3 weeks of treatment with one of the four study drugs. There was no difference in the etiologic, demographic, New York Heart Association therapeutic classification, or ventricular arrhythmia frequency at baseline between the patients randomized to the four groups. There was no statistically significant difference between the percent efficacy for VPC reduction on any drug compared to baseline or in the percent efficacy of reduction in beats of ventricular tachycardia. There was no difference between the four agents in terms of types of side effects noted nor in their overall prevalence or need for premature discontinuation of therapy. This study demonstrated that a variety of quinidine preparations exist that do not differ in terms of their efficacy or safety, but that a long-acting, once-a-day preparation (Quiniday) was as effective and safe as other forms of quinidine despite its once-a-day dosing schedule. More compliant dosing regimens with effective well-known antiarrhythmic agents are important in the treatment of patients with potentially lethal ventricular arrhythmias, in the hope that sudden cardiac death can be prevented.

摘要

一项比较性、固定剂量、平行、随机、双盲试验,旨在确定一种新型每日一次奎尼丁制剂(奎尼达,每日1200毫克)的疗效和安全性,并与硫酸奎尼丁(如喹诺拉,每日4次,每次300毫克,以及奎尼丁缓释片,每日2次,每次600毫克)和葡萄糖酸奎尼丁(如长效喹葡糖片,每日2次,每次648毫克)进行比较。在停用所有先前的抗心律失常药物并经过安慰剂洗脱期后,对76例在48小时动态心电图监测中每小时至少有30次室性早搏(VPC)的患者进行随机分组,接受四种研究药物之一的3周治疗。随机分为四组的患者在基线时的病因、人口统计学、纽约心脏协会治疗分级或室性心律失常频率方面没有差异。与基线相比,任何一种药物降低VPC的疗效百分比或降低室性心动过速搏动次数的疗效百分比之间均无统计学显著差异。四种药物在观察到的副作用类型、总体发生率或提前停药的必要性方面没有差异。这项研究表明,存在多种奎尼丁制剂,它们在疗效或安全性方面没有差异,但一种长效、每日一次的制剂(奎尼达)尽管每日仅给药一次,但其疗效和安全性与其他形式的奎尼丁相同。对于潜在致命性室性心律失常患者的治疗,采用更易依从的有效知名抗心律失常药物给药方案非常重要,以期预防心脏性猝死。

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