Morganroth J
Likoff Cardiovascular Institute, Hahnemann University School of Medicine, Philadelphia, Pennsylvania.
Am J Cardiol. 1987 Dec 1;60(16):1276-81. doi: 10.1016/0002-9149(87)90608-4.
The antiarrhythmic efficacy and safety of oral mexiletine hydrochloride and quinidine sulfate were compared at 29 clinical centers in a double-blind, parallel-group trial involving 491 patients with benign or potentially lethal ventricular arrhythmias. Responders were defined as those who had at least a 70% reduction in the frequency of ventricular premature complexes (VPCs) that persisted for 12 weeks, and who experienced no intolerable side effects that required discontinuation of therapy. Of the patients available for analysis, 71 of 232 (31%) in the mexiletine and 73 of 225 (32%) in the quinidine group met these criteria. The dose range used for mexiletine was 200 to 400 mg every 8 hours, and that for quinidine 200 to 400 mg every 6 hours. More than half of the patients in each group were successfully treated with the smallest dose (200 mg every 8 hours mexiletine vs 200 mg every 6 hours for quinidine). Quinidine significantly prolonged the QT interval, whereas mexiletine did not. Proarrhythmic reactions were recorded in 18 of 221 (9%) patients taking quinidine and 10 of 217 (5%) patients taking mexiletine. There was no difference in the incidence of adverse reactions between the 2 groups; in both, the most common side effects were related to the gastrointestinal and central nervous systems. Mexiletine thus represents an alternative to quinidine for the treatment of patients with ventricular arrhythmias.
在一项双盲、平行组试验中，29个临床中心对491例患有良性或潜在致命性室性心律失常的患者比较了口服盐酸美西律和硫酸奎尼丁的抗心律失常疗效及安全性。反应者定义为室性早搏（VPC）频率至少降低70%且持续12周，并且未出现需要停药的无法耐受的副作用的患者。在可供分析的患者中，美西律组232例中有71例（31%）、奎尼丁组225例中有73例（32%）符合这些标准。美西律的剂量范围为每8小时200至400毫克，奎尼丁为每6小时200至400毫克。每组中超过一半的患者用最小剂量成功治疗（美西律每8小时200毫克 vs 奎尼丁每6小时200毫克）。奎尼丁显著延长QT间期，而美西律则不然。服用奎尼丁的221例患者中有18例（9%）记录到促心律失常反应，服用美西律的217例患者中有10例（5%）。两组不良反应发生率无差异；两组中最常见的副作用均与胃肠道和中枢神经系统有关。因此，美西律是治疗室性心律失常患者的奎尼丁替代药物。
