de Faire U, Ericsson C G, Hamsten A, Nilsson J
Department of Medicine, Karolinska Hospital, Stockholm, Sweden.
Drugs Exp Clin Res. 1995;21(3):105-24.
Young survivors of myocardial infarction represent a poignant challenge to clinical research on atherogenic mechanisms and factors predisposing to and precipitating coronary thrombosis. Young male postinfarction patients are characterized by heavy smoking, dyslipoproteinaemias involving very low density lipoprotein (VLDL), low density lipoprotein (LDL) and high density lipoprotein (HDL), a family history of premature coronary artery disease, hyperinsulinaemic responses to oral and intravenous glucose challenges, an elevated plasma fibrinogen concentration and defective fibrinolytic function. Based on the multiplicity of metabolic and haemostatic disturbances present in these patients, a double-blind, randomized, placebo-controlled angiographic trial was initiated to determine whether bezafibrate, a clofibrate analogue, retards the progression or facilitates regression of premature coronary atherosclerosis. Men under the age of 45 years who survived a first myocardial infarction were screened for participation in the study. A fasting serum cholesterol value > or = 5.2 mmol/l and/or serum triglycerides > or = 1.6 mmol/l after three months of dietary treatment and angiographically demonstrable lesions in at least one coronary segment were required for inclusion. Treatment with diet and bezafibrate (200 mg t.i.d.) or matching placebo is continued for five years during which time re-angiography is performed after two years and at the end of the study. The primary aim of the trial is a comparison between the bezafibrate and placebo groups for change in mean minimum luminal diameter between the baseline and five-year coronary angiograms. This report presents the design features of the Bezafibrate Coronary Atherosclerosis Intervention Trial (BECAIT) and a review of current knowledge of mechanisms underlying premature coronary atherosclerosis and myocardial infarction at a young age.
心肌梗死的年轻幸存者对动脉粥样硬化机制以及易患和促发冠状动脉血栓形成的因素的临床研究提出了严峻挑战。年轻男性心肌梗死后患者的特点是大量吸烟、存在涉及极低密度脂蛋白（VLDL）、低密度脂蛋白（LDL）和高密度脂蛋白（HDL）的血脂异常、有早发冠状动脉疾病家族史、对口服和静脉注射葡萄糖刺激有高胰岛素血症反应、血浆纤维蛋白原浓度升高以及纤溶功能缺陷。基于这些患者存在的多种代谢和止血紊乱情况，启动了一项双盲、随机、安慰剂对照的血管造影试验，以确定氯贝丁酯类似物苯扎贝特是否能延缓早发冠状动脉粥样硬化的进展或促进其消退。对45岁以下首次心肌梗死存活的男性进行筛选以参与该研究。纳入标准要求在饮食治疗三个月后空腹血清胆固醇值≥5.2 mmol/l和/或血清甘油三酯≥1.6 mmol/l，并且在至少一个冠状动脉节段有血管造影可显示的病变。饮食和苯扎贝特（200 mg，每日三次）或匹配的安慰剂治疗持续五年，在此期间，在两年后和研究结束时进行再次血管造影。该试验的主要目的是比较苯扎贝特组和安慰剂组在基线和五年冠状动脉血管造影之间平均最小管腔直径的变化。本报告介绍了苯扎贝特冠状动脉粥样硬化干预试验（BECAIT）的设计特点，并综述了早发冠状动脉粥样硬化和年轻时心肌梗死潜在机制的当前知识。
