Hoffmann E, Mattke S, Haberl R, Steinbeck G
Department of Medicine, University of Munich, Germany.
J Cardiovasc Pharmacol. 1993 Jan;21(1):95-100. doi: 10.1097/00005344-199301000-00014.
We compared the electrophysiologic and clinical effects of oral cibenzoline and sotalol in 12 patients with spontaneous and inducible sustained ventricular tachycardia (VT), using a randomized, open-label, cross-over study. Electrophysiologic studies were performed in the control state, after oral cibenzoline and after oral sotalol, using an incremental dose-titration protocol. Therapy with cibenzoline at the maximum dose level (130-390 mg/day) resulted in complete suppression of VT in 1 of 12 patients (8%). Sotalol (160-320 mg/day) prevented induction of VT in 4 of 12 patients (33%). The effective refractory period (ERP) of the right ventricle was more significantly prolonged with sotalol (p < 0.001) as compared with cibenzoline (p < 0.05). Neither drug prolonged QT duration corrected for frequency (QTc) and cycle length of induced VT, as compared with the control study. Three patients experienced spontaneous VT after cibenzoline administration, and 2 patients experienced incessant VT during programmed electrical stimulation. No patient had a proarrhythmic effect while receiving oral sotalol treatment. Chronic sotalol therapy maintained long-term arrhythmia suppression in all 4 responders at 1-year follow-up. Sotalol appears to have greater efficacy than and a safety profile superior to that of cibenzoline. Drug-related proarrhythmic effects of oral cibenzoline therapy occurred with greater frequency than that associated with other antiarrhythmic drugs. Based on these findings, cibenzoline cannot be recommended for use in patients with VT.
我们采用随机、开放标签、交叉研究的方法,比较了口服西苯唑啉和索他洛尔对12例自发性和诱发性持续性室性心动过速(VT)患者的电生理及临床效果。在对照状态下、口服西苯唑啉后及口服索他洛尔后,使用递增剂量滴定方案进行电生理研究。西苯唑啉最大剂量水平(130 - 390毫克/天)治疗使12例患者中的1例(8%)室性心动过速完全抑制。索他洛尔(160 - 320毫克/天)使12例患者中的4例(33%)不能诱发室性心动过速。与西苯唑啉(p < 0.05)相比,索他洛尔更显著地延长了右心室有效不应期(ERP)(p < 0.001)。与对照研究相比,两种药物均未延长校正频率后的QT间期(QTc)及诱发室性心动过速的周期长度。3例患者在服用西苯唑啉后发生自发性室性心动过速,2例患者在程序性电刺激期间发生持续性室性心动过速。接受口服索他洛尔治疗时,无患者出现促心律失常作用。在1年随访中,所有接受索他洛尔治疗的4例有反应者均维持长期心律失常抑制。索他洛尔似乎比西苯唑啉疗效更好且安全性更高。口服西苯唑啉治疗相关的药物性促心律失常作用比其他抗心律失常药物更频繁。基于这些发现,不推荐西苯唑啉用于室性心动过速患者。