Woosley R L, Siddoway L A, Duff H J, Roden D M
Am J Cardiol. 1984 Feb 27;53(5):59B-65B. doi: 10.1016/0002-9149(84)90504-6.
Flecainide acetate was evaluated in a placebo-controlled, dose-ranging study performed in patients with stable, high-frequency ventricular arrhythmias. Three centers studied 35 patients in a 3-stage protocol. After a placebo baseline, increasing oral dosages from 100 to 300 mg twice daily were evaluated. Placebo was then reinstituted and after arrhythmia had recurred, the patients were discharged on the effective dosage to return to the clinic for evaluation 7 and 14 days later. Thirty of 35 patients had more than 80% suppression (mean 96%) of ventricular premature complexes (VPCs) and more than 95% reduction in complex VPCs. Arrhythmia suppression was seen at dosages of 100 to 200 mg twice daily in 73% of the patients. Twenty-three percent of patients required 500 to 600 mg/day. Mild side effects were seen in 46% of patients. These resolved or became tolerable at lower dosages in most patients. Effective therapy continued for 2 years in 24 of 29 patients, without any evidence of chronic toxicity. Pharmacokinetic studies indicate that many patients require 5 to 7 days of constant dosing before reaching steady state. Flecainide acetate is an effective antiarrhythmic with a narrow range of effective dosages.
在一项针对稳定型高频室性心律失常患者进行的安慰剂对照、剂量范围研究中，对醋酸氟卡尼进行了评估。三个中心按照三阶段方案研究了35例患者。在安慰剂基线期后，评估了每日两次口服剂量从100毫克增加到300毫克的情况。然后重新给予安慰剂，在心律失常复发后，患者以有效剂量出院，7天和14天后返回诊所进行评估。35例患者中有30例室性早搏（VPC）抑制率超过80%（平均96%），复杂性室性早搏减少超过95%。73%的患者在每日两次100至200毫克的剂量下出现心律失常抑制。23%的患者需要500至600毫克/天。46%的患者出现轻度副作用。在大多数患者中，这些副作用在较低剂量时缓解或变得可以耐受。29例患者中有24例有效治疗持续了2年，没有任何慢性毒性的证据。药代动力学研究表明，许多患者在达到稳态之前需要5至7天的持续给药。醋酸氟卡尼是一种有效的抗心律失常药物，有效剂量范围较窄。
