Br J Clin Pharmacol. 1986;21 Suppl 2(Suppl 2):197S-204S.
A double-blind study comparing verapamil with placebo was conducted in 16 Danish departments of internal medicine with coronary care units (CCU). All patients below 75 years of age admitted to the CCU with a suspicion of acute myocardial infarction (AMI) were evaluated. Of 7415 patients, 3917 were excluded on admission because of heart failure, heart block, other severely disabling diseases, or treatment with beta-adrenoceptor blockers or calcium antagonists. Treatment was started in 3498 patients with 0.1 mg kg-1 verapamil i.v. and 120 mg orally on admission followed by 120 mg three times daily, or matched placebo. Treatment was continued for 6 months for patients verified to have had an AMI according to all three WHO criteria. Treatment was stopped in patients for whom the diagnosis of AMI was ruled out. Of 1436 patients with AMI, 717 were treated with verapamil and 719 with placebo. After 6 months, 92 patients (12.8%) in the verapamil group and 100 patients (13.9%) in the placebo group were dead (NS). Fifty patients (7%) in the verapamil group and 60 patients (8.3%) in the placebo group had reinfarctions (NS). After 12 months, 109 patients (15.2%) in the verapamil group and 118 patients (16.4%) in the placebo group were dead (NS). It is concluded that verapamil treatment used in the early phase of an AMI does not improve survival. Based on the experience from the first study we are at present performing a further secondary prevention study with verapamil to a modified design.
在丹麦16个设有冠心病监护病房(CCU)的内科科室进行了一项比较维拉帕米与安慰剂的双盲研究。对所有入住CCU且疑似急性心肌梗死(AMI)的75岁以下患者进行了评估。在7415例患者中,3917例因心力衰竭、心脏传导阻滞、其他严重致残性疾病或接受β-肾上腺素能受体阻滞剂或钙拮抗剂治疗而在入院时被排除。3498例患者开始接受治疗,静脉注射0.1mg/kg维拉帕米,入院时口服120mg,随后每日三次,每次120mg,或给予匹配的安慰剂。根据世界卫生组织的所有三项标准确诊为AMI的患者持续治疗6个月。排除AMI诊断的患者则停止治疗。在1436例AMI患者中,717例接受维拉帕米治疗,719例接受安慰剂治疗。6个月后,维拉帕米组有92例患者(12.8%)死亡,安慰剂组有100例患者(13.9%)死亡(无显著性差异)。维拉帕米组有50例患者(7%)发生再梗死,安慰剂组有60例患者(8.3%)发生再梗死(无显著性差异)。12个月后,维拉帕米组有109例患者(15.2%)死亡,安慰剂组有118例患者(16.4%)死亡(无显著性差异)。得出的结论是,在AMI早期使用维拉帕米治疗并不能提高生存率。基于第一项研究的经验,我们目前正在对维拉帕米进行进一步的二级预防研究,采用改进的设计。