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口服西苯唑啉与奎尼丁治疗室性心律失常的疗效及安全性比较:一项随机交叉研究。

Comparative efficacy and safety of oral cibenzoline and quinidine in ventricular arrhythmias: a randomized crossover study.

作者信息

Wasty N, Saksena S, Barr M J

出版信息

Am Heart J. 1985 Dec;110(6):1181-8. doi: 10.1016/0002-8703(85)90009-2.

Abstract

We compared the clinical efficacy and safety of oral cibenzoline and quinidine in 13 patients with complex ventricular arrhythmias using a randomized, open-label, crossover study. Employing an incremental dose titration protocol, cibenzoline (130 mg twice daily and 160 mg twice daily) and quinidine (300 mg every 6 hours and 400 mg every 6 hours) were administered for 7 days at each dose level, with preceding washout periods. ECG intervals, total number of ventricular premature depolarizations (VPDs), ventricular pairs (VP), and ventricular tachycardia (VT) events were analyzed at control on cibenzoline and on quinidine. Suppression of VPDs was comparable on both drugs (cibenzoline--six patients; quinidine--five patients). Mean serum quinidine concentration was 2.6 +/- 1.2 micrograms/ml, and plasma cibenzoline concentration was 0.48 +/- 0.27 micrograms/ml. Significant clinical and laboratory toxicity was more frequent with quinidine than with cibenzoline (p less than 0.05). Chronic cibenzoline therapy maintained long-term arrhythmia suppression in five of six responders (mean follow-up, 23 +/- 12 weeks). We conclude that cibenzoline and quinidine are equally effective for control of ventricular arrhythmias. Cibenzoline has a more desirable dosing regimen, superior safety profile, and better patient tolerance than quinidine.

摘要

我们采用随机、开放标签、交叉研究方法,比较了口服西苯唑啉和奎尼丁对13例复杂性室性心律失常患者的临床疗效和安全性。按照递增剂量滴定方案,在每个剂量水平下,西苯唑啉(每日两次,每次130mg和每日两次,每次160mg)和奎尼丁(每6小时300mg和每6小时400mg)各给药7天,给药前有洗脱期。在服用西苯唑啉和奎尼丁的对照期,分析心电图间期、室性早搏(VPD)总数、室性成对搏动(VP)和室性心动过速(VT)事件。两种药物对VPD的抑制作用相当(西苯唑啉——6例患者;奎尼丁——5例患者)。奎尼丁平均血清浓度为2.6±1.2μg/ml,西苯唑啉血浆浓度为0.48±0.27μg/ml。奎尼丁比西苯唑啉更频繁出现显著的临床和实验室毒性(p<0.05)。在6例有反应者中的5例,长期西苯唑啉治疗维持了长期心律失常抑制(平均随访23±12周)。我们得出结论,西苯唑啉和奎尼丁在控制室性心律失常方面同样有效。与奎尼丁相比,西苯唑啉有更理想的给药方案、更好的安全性和更好的患者耐受性。

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