The CAPS Coordinating Center, University of Washington, JD-22, 1107 Northeast 45th, Room 505, Seattle, Washington 98105, USA.
Am J Cardiol. 1988 Mar 1;61(8):501-9. doi: 10.1016/0002-9149(88)90754-0.
The National Heart, Lung, and Blood Institute initiated the Cardiac Arrhythmia Pilot Study (CAPS) to evaluate the feasibility of suppressing ventricular arrhythmias after acute myocardial infarction. Ten centers enrolled 502 patients younger than 75 years of age with greater than or equal to 10 ventricular premature complexes (VPC) per hour in a 24-hour electrocardiographic recording and a left ventricular ejection fraction greater than 20%. Patients were enrolled 6 to 60 days after acute myocardial infarction and randomized to 1 of 5 treatment tracks with 2 drugs that included encainide, flecainide, imipramine, moricizine or placebo. During a double-blind drug and dose selection phase, investigators were permitted to change drug or dosage to achieve greater than or equal to 70% suppression in VPC frequency and greater than 90% suppression of runs of VPC with the exception of patients assigned to placebo, who continued receiving it. Patients were followed for a year after randomization. Patients in the 5 treatment arms were similar in age, sex, clinical characteristics, VPC frequency, left ventricular ejection fraction and concomitant drug treatment. As first drugs, encainide and flecainide had higher efficacy rates, 79% and 83%, respectively, than imipramine, 52%, moricizine, 66%, or placebo, 37%. Encainide and flecainide also had high efficacy rates, 68% and 69%, in patients who failed imipramine or moricizine. Encainide, flecainide and moricizine were well tolerated. These 3 drugs had intolerable adverse effect rates of 6% or less, i.e., similar to placebo. More than 70T of the patients who started the follow-up phase on encainide, flecainide or moricizine remained on these drugs to the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS)
美国国立心肺血液研究所发起了心律失常试点研究（CAPS），以评估抑制急性心肌梗死后室性心律失常的可行性。10个中心招募了502名年龄小于75岁的患者，这些患者在24小时心电图记录中每小时有大于或等于10次室性早搏（VPC），且左心室射血分数大于20%。患者在急性心肌梗死后6至60天入组，并随机分配到5个治疗组中的1组，使用包括恩卡尼、氟卡尼、丙咪嗪、莫雷西嗪或安慰剂在内的2种药物。在双盲药物和剂量选择阶段，除分配到安慰剂组的患者继续接受安慰剂外，研究人员可改变药物或剂量，以使VPC频率抑制大于或等于70%，VPC连发抑制大于90%。随机分组后对患者进行了一年的随访。5个治疗组的患者在年龄、性别、临床特征、VPC频率、左心室射血分数和伴随药物治疗方面相似。作为首选药物，恩卡尼和氟卡尼的有效率分别为79%和83%，高于丙咪嗪的52%、莫雷西嗪的66%或安慰剂的37%。在丙咪嗪或莫雷西嗪治疗失败的患者中，恩卡尼和氟卡尼的有效率也很高，分别为68%和69%。恩卡尼、氟卡尼和莫雷西嗪耐受性良好。这3种药物的不耐受不良反应发生率为6%或更低，即与安慰剂相似。在随访阶段开始使用恩卡尼、氟卡尼或莫雷西嗪的患者中，超过70%的患者在研究结束时仍继续使用这些药物。（摘要截短于250字）
