Scrutinio D, Lagioia R, Rizzon P
Clinica del Lavoro Foundation, Institute of Care and Research, Bari, Italy.
Eur Heart J. 1991 Dec;12 Suppl G:27-9.
Data collected to investigate the effects of ticlopidine in a subset of 489 patients with angina at rest accompanied by transient ischaemic electrocardiographic changes have been analysed. Of the 489 patients, 255 received conventional treatment including beta-blockers, nitrates, or calcium antagonists (control group); 234 received conventional treatment plus ticlopidine 250 mg b.i.d. (ticlopidine group). The predefined end-points were vascular death and acute myocardial infarction (AMI). The incidence of end-points was assessed according to the intention-to-treat principle. The post-hoc estimated statistical power was 80%. The rate of death or AMI in the 6-month follow-up period was reduced from 14.9 to 6.8% (-54.4%) (odds ratio: 0.42; confidence intervals: 0.22, 0.80). The incidence of fatal or nonfatal AMI was reduced from 12.2 to 4.3% (-65%) (odds ratio: 0.32; confidence intervals: 0.14, 0.70) and of nonfatal AMI from 10.2 to 3.8% (-63%) (odds ratio: 0.35; confidence intervals: 0.15, 0.80). Nineteen patients died; 12 in the control group (4.7%) and seven in the ticlopidine group (83%) (-36%) (odds ratio: 0.62; confidence intervals: 0.21, 1.74); five patients in the control group and only one in the ticlopidine group died of an AMI. The post-hoc estimated statistical power was 80%. However, we cannot draw definitive conclusions about the clinical effect of ticlopidine treatment in the patients with angina at rest accompanied by transient ischaemic electrocardiographic changes because the subgroup analysis was not planned a priori. Nevertheless, this report strongly suggests that such patients can benefit from antiplatelet treatment with ticlopidine; the benefit mainly depends on the protective effect against myocardial infarction.
已对收集的用于研究噻氯匹定对489例静息性心绞痛伴短暂性缺血性心电图改变患者亚组影响的数据进行了分析。在这489例患者中,255例接受了包括β受体阻滞剂、硝酸盐或钙拮抗剂在内的常规治疗(对照组);234例接受了常规治疗加噻氯匹定250mg每日两次(噻氯匹定组)。预先设定的终点为血管性死亡和急性心肌梗死(AMI)。根据意向性治疗原则评估终点发生率。事后估计的统计效能为80%。在6个月随访期内,死亡或AMI发生率从14.9%降至6.8%(-54.4%)(比值比:0.42;可信区间:0.22,0.80)。致命或非致命AMI发生率从12.2%降至4.3%(-65%)(比值比:0.32;可信区间:0.14,0.70),非致命AMI发生率从10.2%降至3.8%(-63%)(比值比:0.35;可信区间:0.15,0.80)。19例患者死亡;对照组12例(4.7%),噻氯匹定组7例(83%)(-36%)(比值比:0.62;可信区间:0.21,1.74);对照组5例患者死于AMI,噻氯匹定组仅1例。事后估计的统计效能为80%。然而,由于亚组分析并非预先计划,我们无法就噻氯匹定治疗对静息性心绞痛伴短暂性缺血性心电图改变患者的临床效果得出明确结论。尽管如此,本报告强烈提示此类患者可从噻氯匹定抗血小板治疗中获益;获益主要取决于对心肌梗死的保护作用。