Reimold S C, Cantillon C O, Friedman P L, Antman E M
Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts 02115.
Am J Cardiol. 1993 Mar 1;71(7):558-63. doi: 10.1016/0002-9149(93)90511-a.
Because conventional antiarrhythmic therapy is often ineffective in maintaining sinus rhythm or is associated with adverse side effects in patients with atrial fibrillation (AF), there is a clinical need to test newer agents. One hundred patients with AF who had unsuccessful therapy with 1.9 +/- 1.0 type IA antiarrhythmic agents were randomized to receive either propafenone (n = 50) or sotalol (n = 50). Patients were stratified into 4 groups based on AF pattern (chronic vs paroxysmal) and left atrial size (large [> or = 4.5 cm] vs small [< 4.5]). The proportion of patients remaining in sinus rhythm on each agent was calculated for each group by the Kaplan-Meier method. For patients randomized to propafenone, 46 +/- 8%, 41 +/- 8% and 30 +/- 8% remained in sinus rhythm at 3, 6 and 12 months, respectively, after cardioversion. A similar proportion of patients treated with sotalol remained in sinus rhythm at follow-up (49 +/- 7%, 46 +/- 8% and 37 +/- 8% at 3, 6 and 12 months, respectively; p = NS). The proportion of patients remaining in sinus rhythm on propafenone and sotalol was not dependent on arrhythmia pattern or left atrial dimension. Except for constipation that occurred more frequently in patients treated with propafenone, adverse side effects were equally distributed between the 2 therapies. Two patients receiving sotalol died during follow-up. Propafenone and sotalol, 2 new antiarrhythmic agents, were found to be equally effective in maintaining sinus rhythm in 100 patients with recurrent AF. Response rates were not affected by arrhythmia pattern, left atrial size or unsuccessful prior drug therapy.(ABSTRACT TRUNCATED AT 250 WORDS)
由于传统抗心律失常治疗在维持房颤(AF)患者的窦性心律方面往往无效,或伴有不良副作用,因此临床上需要对新型药物进行试验。100例接受1.9±1.0种IA类抗心律失常药物治疗无效的房颤患者被随机分为普罗帕酮组(n = 50)和索他洛尔组(n = 50)。根据房颤类型(慢性与阵发性)和左心房大小(大[≥4.5 cm]与小[<4.5 cm])将患者分为4组。采用Kaplan-Meier法计算每组中使用每种药物后维持窦性心律的患者比例。对于随机分配到普罗帕酮组的患者,复律后3、6和12个月时分别有46±8%、41±8%和30±8%的患者维持窦性心律。索他洛尔治疗的患者在随访中维持窦性心律的比例相似(3、6和12个月时分别为49±7%、46±8%和37±8%;p =无显著性差异)。普罗帕酮和索他洛尔治疗后维持窦性心律的患者比例不依赖于心律失常类型或左心房大小。除了普罗帕酮治疗的患者便秘发生率更高外,两种治疗的不良副作用分布相同。两名接受索他洛尔治疗的患者在随访期间死亡。发现普罗帕酮和索他洛尔这两种新型抗心律失常药物在100例复发性房颤患者中维持窦性心律的效果相同。有效率不受心律失常类型、左心房大小或先前药物治疗无效的影响。(摘要截短至250字)