Pritchett E L, DaTorre S D, Platt M L, McCarville S E, Hougham A J
Duke University Medical Center, Durham, North Carolina 27710.
J Am Coll Cardiol. 1991 Feb;17(2):297-303. doi: 10.1016/s0735-1097(10)80090-7.
The dose-response relations for efficacy and tolerance of the antiarrhythmic drug flecainide acetate were studied in 28 patients with paroxysmal supraventricular tachycardia (Group 1) and 45 patients with paroxysmal atrial fibrillation or flutter (Group 2). Recurrent symptomatic tachycardia was documented with use of transtelephonic electrocardiographic recording. Patients received flecainide in doses of 25, 50, 100 and 150 mg twice daily and placebo for 1 month treatment periods. Among 14 patients in Group 1 who qualified for efficacy analysis, 4 (29%) had no tachycardia while taking placebo. The number with no tachycardia increased with progressively larger flecainide doses; with the 150 mg twice daily dose, 12 (86%) of 14 patients had no tachycardia (p less than 0.01 for overall differences among all treatments). Among 28 patients in Group 2, 2 (7%) had no tachycardia while taking placebo. The number with no tachycardia also increased with progressively larger flecainide doses; with the 150 mg twice daily dose, 17 (61%) of 28 patients had no tachycardia (p less than 0.01 for overall differences among all treatments). Noncardiac adverse experiences were the leading cause of premature study discontinuation during flecainide treatment periods (five patients in Group 1 and six patients in Group 2).
在28例阵发性室上性心动过速患者(第1组)和45例阵发性心房颤动或扑动患者(第2组)中研究了抗心律失常药物醋酸氟卡尼的疗效和耐受性的剂量反应关系。通过电话心电图记录证实有复发性症状性心动过速。患者接受每日两次剂量为25、50、100和150mg的氟卡尼及安慰剂治疗,疗程为1个月。在第1组符合疗效分析条件的14例患者中,14例中有4例(29%)服用安慰剂时无心动过速。无心动过速的患者数量随着氟卡尼剂量的逐渐增加而增加;每日两次150mg剂量时,14例患者中有12例(86%)无心动过速(所有治疗之间的总体差异p<0.01)。在第2组的28例患者中,28例中有2例(7%)服用安慰剂时无心动过速。无心动过速的患者数量也随着氟卡尼剂量的逐渐增加而增加;每日两次150mg剂量时,28例患者中有17例(61%)无心动过速(所有治疗之间的总体差异p<0.01)。非心脏不良事件是氟卡尼治疗期间研究提前终止的主要原因(第1组5例患者,第2组6例患者)。