Salerno D M, Krejci J, Granrud G, Hodges M
Division of Cardiology, Hennepin County Medical Center, University of Minnesota, Minneapolis 55415.
J Am Coll Cardiol. 1988 Apr;11(4):843-50. doi: 10.1016/0735-1097(88)90221-5.
Ten patients were treated with oral indecainide for frequent ventricular ectopic depolarizations during a short-term, dose-ranging, single blind inpatient trial followed by open label long-term therapy for 2 years. During dose ranging, patients received placebo followed by 50, 75 and 100 mg of indecainide three times daily. Eight of the 10 patients achieved greater than or equal to 80% reduction in ventricular ectopic depolarizations during inpatient therapy. Mean ventricular ectopic depolarizations decreased from 15,792/24 h to 2,357/24 h on optimal dosage (p less than 0.01). Nine patients had paired ventricular ectopic depolarizations; four of the nine had greater than or equal to 99% reduction of these beats. Among seven patients with nonsustained ventricular tachycardia, five had 100% elimination of these events with indecainide and all had greater than or equal to 90% reduction in these events. Indecainide prolonged the PR interval 44 +/- 27 ms (p less than 0.0001) and the QRS interval 11 +/- 9 ms (p less than 0.0001) from baseline without prolongation of the QTc or JTc interval. The mean trough plasma level of indecainide on optimal dosage was 409 +/- 173 ng/ml and the mean plasma elimination half-life was 10.3 +/- 2.3 h (range 7.1 to 14.2). No adverse hemodynamic effects of indecainide were detected. Side effects during short-term therapy were mild and did not require discontinuation of the drug. Efficacy was maintained for some patients during long-term therapy for 2 years, although five patients discontinued therapy because of loss of efficacy or side effects. Indecainide is a highly effective and well tolerated antiarrhythmic drug for suppression of frequent and repetitive ventricular ectopic depolarizations.
在一项短期、剂量范围、单盲住院患者试验中，10名患者因频发室性异位去极化接受口服英地卡胺治疗，随后进行了为期2年的开放标签长期治疗。在剂量范围试验期间，患者先接受安慰剂治疗，然后每日三次分别给予50、75和100毫克英地卡胺。10名患者中有8名在住院治疗期间室性异位去极化减少了80%或更多。在最佳剂量下，平均室性异位去极化从每24小时15792次降至每24小时2357次（p<0.01）。9名患者有配对的室性异位去极化；其中4名患者这些搏动减少了99%或更多。在7名非持续性室性心动过速患者中，5名患者使用英地卡胺后这些事件完全消除，且所有患者这些事件减少了90%或更多。英地卡胺使PR间期较基线延长44±27毫秒（p<0.0001），QRS间期延长11±9毫秒（p<0.0001），而QTc或JTc间期未延长。最佳剂量下英地卡胺的平均谷浓度为409±173纳克/毫升，平均血浆消除半衰期为10.3±2.3小时（范围7.1至14.2小时）。未检测到英地卡胺有不良血流动力学效应。短期治疗期间的副作用轻微，无需停药。尽管有5名患者因疗效丧失或出现副作用而停药，但在一些患者的2年长期治疗中疗效得以维持。英地卡胺是一种高效且耐受性良好的抗心律失常药物，可用于抑制频发和反复的室性异位去极化。
