Morganroth J, Anderson J L, Gentzkow G D
J Am Coll Cardiol. 1986 Sep;8(3):607-15. doi: 10.1016/s0735-1097(86)80190-5.
Antiarrhythmic therapy is known to be associated with a significant risk of adverse cardiac reactions, including a proarrhythmic response. This study assessed in 1,330 patients followed up for 292 +/- 393 days the predictive value for cardiovascular safety of a system by which patients were classified according to ventricular arrhythmias on entry, presence or absence of organic heart disease and drug dose for flecainide acetate. Baseline arrhythmia subgroups included patients with premature ventricular complexes only, nonsustained ventricular tachycardia, and sustained ventricular tachycardia. Proarrhythmic events occurred in 6.8% of patients overall and were serious in 2.3% and lethal in 1.0%. However, proarrhythmia was highly dependent on arrhythmia class on entry: serious nonlethal proarrhythmic events occurred in 6.6% of patients with sustained ventricular tachycardia, only 0.9% with nonsustained ventricular tachycardia and 0% with premature ventricular complexes (p less than 0.01). Proarrhythmic death occurred in 3.1% of patients with sustained ventricular tachycardia, 0.2% with nonsustained ventricular tachycardia and 0% with premature ventricular complexes only (p less than 0.01). Proarrhythmia was also influenced by the presence of structural heart disease: serious nonlethal proarrhythmia occurred in 2.6% of patients with versus 0.4% of those without organic heart disease, and death occurred in 1.2 versus 0%, respectively. These adverse events were also dependent on dosing regimen. Flecainide caused premature discontinuation due to new or worsened heart failure in 1.4% of patients, all with underlying organic heart disease; however, heart failure was not clearly related to dose or type of arrhythmia. Symptomatic conduction disturbances occurred in 2.2%, and were predicted by preexistent sinus node disease but not by other baseline features.(ABSTRACT TRUNCATED AT 250 WORDS)
已知抗心律失常治疗与发生严重心脏不良反应的风险相关，包括致心律失常反应。本研究对1330例患者进行了为期292±393天的随访，评估了一种系统对心血管安全性的预测价值，该系统根据患者入组时的室性心律失常、有无器质性心脏病以及醋酸氟卡尼的药物剂量进行分类。基线心律失常亚组包括仅患有室性早搏的患者、非持续性室性心动过速患者和持续性室性心动过速患者。总体而言，6.8%的患者发生了致心律失常事件，其中2.3%为严重事件，1.0%为致命事件。然而，致心律失常高度依赖于入组时的心律失常类型：持续性室性心动过速患者中6.6%发生了严重非致命性致心律失常事件，非持续性室性心动过速患者中仅0.9%发生，室性早搏患者中为0%（p<0.01）。持续性室性心动过速患者中3.1%发生了致心律失常死亡，非持续性室性心动过速患者中0.2%发生，仅患有室性早搏的患者中为0%（p<0.01）。致心律失常还受结构性心脏病的影响：患有器质性心脏病的患者中2.6%发生了严重非致命性致心律失常，而无器质性心脏病的患者中为0.4%，死亡发生率分别为1.2%和0%。这些不良事件也取决于给药方案。氟卡尼导致1.4%的患者因新发或加重的心力衰竭而提前停药，所有这些患者均有潜在的器质性心脏病；然而，心力衰竭与剂量或心律失常类型并无明确关联。有症状的传导障碍发生率为2.2%，可由既往存在的窦房结疾病预测，但不能由其他基线特征预测。（摘要截选至250字）
