Boriani G, Lubinski A, Capucci A, Niederle R, Kornacewicz-Jack Z, Wnuk-Wojnar A M, Borggrefe M, Brachmann J, Biffi M, Butrous G S
Istituto di Cardiologia, Università di Bologna, Italy.
Eur Heart J. 2001 Dec;22(23):2180-91. doi: 10.1053/euhj.2001.2679.
Antiarrhythmic drugs are still used for the treatment of ventricular tachyarrhythmias, in combination with implantable cardioverter-defibrillators or without them.
In a double-blind randomized crossover design, the short- and long-term efficacy and safety of oral dofetilide or oral sotalol were compared in 135 patients with ischaemic heart disease and inducible sustained ventricular tachycardia.
The inducibility of ventricular tachycardia was determined by programmed electrophysiological stimulation at baseline. Patients were then blindly randomized to receive either oral dofetilide 500 microg twice daily or oral sotalol 160 mg twice daily, for 3 to 5 days. Suppression of inducible ventricular tachycardia on the drug was then assessed by programmed electrophysiological stimulation. After a wash-out period of at least 2.5 days, the patients received the alternative treatment for 3 to 5 days. Suppression of inducible ventricular tachycardia on the alternate drug was again determined by programmed electrophysiological stimulation. Selection of long-term treatment was allocated blindly according to programmed electrophysiological stimulation results.
During the acute phase, 128 patients received both dofetilide and sotalol. Sixty-seven patients were responders to either drug. Forty-six patients (35.9%) were responders to dofetilide compared with 43 (33.6%) to sotalol (P=ns). Only 23 patients responded to both dofetilide and sotalol. Adverse events, deemed to be treatment related, were seen in 2.3% of patients receiving dofetilide and 8.6% of patients receiving sotalol (P=0.016). Three patients on dofetilide had torsade de pointes. Two patients receiving sotalol died during the acute phase (one was arrhythmic death, and the other was due to heart failure). During the long-term phase, two of 42 patients (4.8%) receiving dofetilide and three of 27 patients (11.1%) receiving sotalol withdrew from treatment due to lack of efficacy. Overall, during the long-term phase, 23.8% of the patients receiving dofetilide and 37.0% of the patients receiving sotalol, withdrew from treatment with a similar pattern of withdrawals for the two drugs.
Dofetilide was as efficacious as sotalol in preventing the induction of sustained ventricular tachycardia. There was no concordance in the response rate in two-thirds of the patients. Dofetilide was significantly better tolerated during the acute phase than sotalol. Both dofetilide and sotalol were well tolerated during the long term with no statistically significant difference in the adverse events.
抗心律失常药物仍用于治疗室性快速性心律失常，可与植入式心脏复律除颤器联合使用，也可单独使用。
在一项双盲随机交叉设计中，比较了135例缺血性心脏病且可诱发持续性室性心动过速患者口服多非利特或口服索他洛尔的短期和长期疗效及安全性。
在基线时通过程控电生理刺激确定室性心动过速的可诱发性。然后患者被随机分为两组，一组每天两次口服500微克多非利特，另一组每天两次口服160毫克索他洛尔，持续3至5天。之后通过程控电生理刺激评估药物对可诱发性室性心动过速的抑制作用。经过至少2.5天的洗脱期后，患者接受另一种治疗3至5天。再次通过程控电生理刺激确定替代药物对可诱发性室性心动过速的抑制作用。根据程控电生理刺激结果盲目分配长期治疗药物。
在急性期，128例患者接受了多非利特和索他洛尔两种药物治疗。67例患者对其中任何一种药物有反应。46例患者（35.9%）对多非利特有反应，而对索他洛尔有反应的患者为43例（33.6%）（P=无显著差异）。只有23例患者对多非利特和索他洛尔均有反应。在接受多非利特治疗的患者中，2.3%出现了被认为与治疗相关的不良事件，而接受索他洛尔治疗的患者中这一比例为8.6%（P=0.016）。3例服用多非利特的患者发生了尖端扭转型室速。2例接受索他洛尔治疗的患者在急性期死亡（1例死于心律失常，另1例死于心力衰竭）。在长期治疗阶段，42例接受多非利特治疗的患者中有2例（4.8%）因疗效不佳退出治疗，27例接受索他洛尔治疗的患者中有3例（11.1%）退出治疗。总体而言，在长期治疗阶段，接受多非利特治疗的患者中有23.8%退出治疗，接受索他洛尔治疗的患者中有37.0%退出治疗，两种药物的退出模式相似。
多非利特在预防持续性室性心动过速诱发方面与索他洛尔疗效相当。三分之二的患者在反应率上不一致。在急性期，多非利特的耐受性明显优于索他洛尔。多非利特和索他洛尔在长期治疗中耐受性均良好，不良事件无统计学显著差异。
