Vaage-Nilsen M, Rasmussen V, Hansen J F, Hagerup L, Sørensen M B, Pedersen-Bjergaard O, Mellemgaard K, Holländer N H, Nielsen I, Sigurd B M
Holter Laboratory, Department of Cardiology, Hvidovre University Hospital, Denmark.
Cardiovasc Drugs Ther. 1994 Feb;8(1):147-51. doi: 10.1007/BF00877103.
The present study was a prospectively planned subset of the postinfarction, double blind, randomized, multicenter, placebo controlled trial of verapamil, DAVIT II. Patients had 24 hours of Holter monitoring before randomization, i.e., second week after infarction (placebo, n = 122; verapamil, n = 128), after 1 month (placebo, n = 108; verapamil, n = 94) and after 16 months (placebo, n = 75; verapamil, n = 63) of treatment. The purpose was to evaluate the effect of verapamil on the prevalence and changes over time of arrhythmias and heart rate. In patients monitored twice, a significant increase of average ventricular premature complexes (VPC) per hour from before to 1 month (p = 0.0007) and 16 months (p = 0.02) after was demonstrated in the placebo group, and from before to 1 months (p = 0.01) after in the verapamil group. Average VPC/hr did not change from 1 to 16 months of treatment. A significant increment of > 10 VPC/hr was found after 1 (p = 0.03) and 16 months (p = 0.05) compared to prerandomization in the placebo, but not in the verapamil group. A significant increase of supraventricular arrhythmias after 1 month compared with prerandomization was found in the placebo group (p = 0.003) but not in the verapamil group. The prevalence of VPC and supraventricular tachycardia was significantly lower in the verapamil compared with the placebo group after 1 month of treatment. At 16 months no significant difference was found between the two groups. The 24 hour mean heart rate was significantly lower, 3 beats/min, in the verapamil compared with placebo after 1 and 16 months of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究是维拉帕米心肌梗死后双盲、随机、多中心、安慰剂对照试验DAVIT II中一项前瞻性规划的子研究。患者在随机分组前,即梗死(安慰剂组,n = 122;维拉帕米组,n = 128)后第二周、治疗1个月后(安慰剂组,n = 108;维拉帕米组,n = 94)和16个月后(安慰剂组,n = 75;维拉帕米组,n = 63)进行24小时动态心电图监测。目的是评估维拉帕米对心律失常患病率及其随时间变化以及心率的影响。在接受两次监测的患者中,安慰剂组每小时平均室性早搏(VPC)从基线到治疗1个月(p = 0.0007)和16个月(p = 0.02)后显著增加,维拉帕米组从基线到治疗1个月后(p = 0.01)增加。治疗1至16个月期间,平均每小时室性早搏数未发生变化。与随机分组前相比,安慰剂组在治疗1个月(p = 0.03)和16个月(p = 0.05)后发现每小时室性早搏增加>10次有显著差异,而维拉帕米组未出现。安慰剂组在治疗1个月后与随机分组前相比,室上性心律失常显著增加(p = 0.003),而维拉帕米组未出现。治疗1个月后,维拉帕米组室性早搏和室上性心动过速的患病率显著低于安慰剂组。在16个月时,两组之间未发现显著差异。治疗1个月和16个月后,维拉帕米组24小时平均心率比安慰剂组显著低3次/分钟。(摘要截选至250字)