Cruz Cruz F, Iturralde Torres P, Picos Bovio E, Medeiros Domingo A, Infante Vázquez O
Departamento de Electrocardiografía y Electrofisiología, Instituto Nacional de Cardiología Ignacio Chávez, México, D.F.
Arch Inst Cardiol Mex. 1998 Nov-Dec;68(6):482-91.
Data on short and long term efficacy and safety of d,l sotalol in patients with atrial fibrillation or atrial flutter is limited. The aims of this study were to (1) assess the antiarrhythmic efficacy of d,l sotalol maintaining normal sinus rhythm in patients with refractory atrial fibrillation or flutter, (2) evaluate the efficacy of d,l sotalol in preventing recurrences of paroxysmal atrial fibrillation or flutter, (3) evaluate the control of ventricular rate in patients with paroxysmal or refractory atrial fibrillation or flutter unsuccessfully treated with other antiarrhythmic agents, (4) determine predictors of efficacy (5) assess the safety of d,l sotalol in this setting. Two hundred patients with chronic or paroxysmal atrial fibrillation or atrial flutter or both, who had failed one to six previous antiarrhythmic drug trials were treated with d,l sotalol 80 to 440 mg/day orally. Fifty four percent was female, age 47 +/- 16 years (range 7-79), follow up period 7 +/- 7 months (range 1 to 14 months), 79% of patients had the arrhythmia for more than one year. The atrial fibrillation in 37.5% of patients was chronic and paroxysmal in 23.5. The atrial flutter was chronic in 31% of patients and paroxysmal in 8%. Eighty two percent of patients was in functional class I (NYHA) and 82% had cardiac heart disease: left atrial (LA) size 44 +/- 10 mm, right atrial (RA) size 37 +/- 7 mm and left ventricular ejection fraction (LVEF) 58 +/- 8%. Total success was achieved in 58% of patients (atrial fibrillation 40% and 18% in atrial flutter), partial success in 38% (atrial fibrillation in 18% and 20% in atrial flutter) and 4% of patients failure. It was p < 0.07 when compared total success vs partial success among atrial fibrillation and atrial flutter groups. Patients with cardiac heart disease responded worst (p = 0.10) to the drug than those without it, specially if the heart was dilated. We concluded that d,l sotalol has moderate efficacy to convert and maintain normal sinus rhythm, as well as it acts controlling paroxysmal relapses and ventricular heart rate.
关于消旋索他洛尔在心房颤动或心房扑动患者中的短期和长期疗效及安全性的数据有限。本研究的目的是:(1)评估消旋索他洛尔在难治性心房颤动或扑动患者中维持正常窦性心律的抗心律失常疗效;(2)评价消旋索他洛尔预防阵发性心房颤动或扑动复发的疗效;(3)评估消旋索他洛尔对经其他抗心律失常药物治疗无效的阵发性或难治性心房颤动或扑动患者心室率的控制情况;(4)确定疗效的预测因素;(5)评估在这种情况下消旋索他洛尔的安全性。200例慢性或阵发性心房颤动或心房扑动或两者兼具且先前1至6次抗心律失常药物试验失败的患者,口服消旋索他洛尔80至440mg/天进行治疗。54%为女性,年龄47±16岁(范围7 - 79岁),随访期7±7个月(范围1至14个月),79%的患者心律失常持续时间超过1年。37.5%的患者心房颤动为慢性,23.5%为阵发性。31%的患者心房扑动为慢性,8%为阵发性。82%的患者心功能为I级(纽约心脏协会),82%患有心脏病:左心房(LA)大小44±10mm,右心房(RA)大小37±7mm,左心室射血分数(LVEF)58±8%。58%的患者获得完全成功(心房颤动患者中为40%,心房扑动患者中为18%),38%的患者部分成功(心房颤动患者中为18%,心房扑动患者中为20%),4%的患者治疗失败。心房颤动和心房扑动组完全成功与部分成功相比,p<0.07。患有心脏病的患者对该药物的反应比未患心脏病的患者差(p = 0.10),特别是心脏扩大的患者。我们得出结论,消旋索他洛尔在转复和维持正常窦性心律方面有中等疗效,并且在控制阵发性复发和心室率方面也有作用。