Am J Cardiol. 1986 Jun 1;57(15):1299-304. doi: 10.1016/0002-9149(86)90208-0.
Ninety-four patients with ventricular tachycardia (VT), 49 with sustained and 45 with nonsustained VT, who had been refractory to or intolerant of other antiarrhythmic agents were treated in a multicenter, open-label study with flecainide acetate. Most had serious cardiac disorders associated with their arrhythmia: 49 patients (52%) had 1 or more conduction disorders on electrocardiography; 43 (46%) had congestive heart failure; 30 (33%) had left ventricular ejection fractions of 30% or less. Patients were initially treated orally in the hospital with 100 mg twice daily; dosage was titrated upward as needed at 4-day intervals to a maximal dose of 200 mg twice daily. Flecainide plasma level monitoring was performed to ensure plasma levels remained in the therapeutic range of 0.2 to 1.0 micrograms/ml. Patients were discharged with flecainide therapy if investigators judged it to be safe and effective. Minimum efficacy requirements included elimination of sustained VT and reduction of other ventricular arrhythmias as determined by 1 or more of the following: 24-hour electrocardiographic monitoring, programmed electrical stimulation, exercise testing and in-hospital monitoring. Sixty-eight patients (72%) were discharged with flecainide therapy. After a mean follow-up of 8 months, 45 patients (48%) were still taking flecainide, including 22 of 49 (45%) with sustained and 23 of 45 (51%) with nonsustained VT. Nine patients with sustained VT and 1 patient with nonsustained VT had aggravation of arrhythmia. Two patients had third-degree heart block. Nine patients died after discharge from the hospital: 6 from out-of-hospital sudden death and 3 from acute myocardial infarctions.(ABSTRACT TRUNCATED AT 250 WORDS)
94例室性心动过速(VT)患者,其中49例为持续性室性心动过速,45例为非持续性室性心动过速,这些患者对其他抗心律失常药物难治或不耐受,在一项多中心、开放标签研究中接受了醋酸氟卡尼治疗。大多数患者的心律失常伴有严重心脏疾病:49例患者(52%)心电图有1种或更多传导障碍;43例(46%)有充血性心力衰竭;30例(33%)左心室射血分数为30%或更低。患者最初在医院口服给药,每日2次,每次100mg;根据需要每4天递增剂量,最大剂量为每日2次,每次200mg。进行氟卡尼血浆水平监测以确保血浆水平维持在0.2至1.0微克/毫升的治疗范围内。如果研究者认为安全有效,患者可出院并继续氟卡尼治疗。最低疗效要求包括消除持续性室性心动过速以及减少其他室性心律失常,这由以下1种或更多方法确定:24小时心电图监测、程控电刺激、运动试验和住院监测。68例患者(72%)出院时继续接受氟卡尼治疗。平均随访8个月后,45例患者(48%)仍在服用氟卡尼,其中持续性室性心动过速患者中的22例(45%)以及非持续性室性心动过速患者中的23例(51%)。9例持续性室性心动过速患者和1例非持续性室性心动过速患者心律失常加重。2例患者发生三度房室传导阻滞。9例患者出院后死亡:6例死于院外猝死,3例死于急性心肌梗死。(摘要截选至250字)