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苏格兰西部冠心病预防研究中的筛查经历及基线特征。WOSCOPS研究小组。苏格兰西部冠心病预防研究。

Screening experience and baseline characteristics in the West of Scotland Coronary Prevention Study. The WOSCOPS Study Group. West of Scotland Coronary Prevention Study.

出版信息

Am J Cardiol. 1995 Sep 1;76(7):485-91. doi: 10.1016/s0002-9149(99)80135-0.

DOI:10.1016/s0002-9149(99)80135-0
PMID:7653449
Abstract

The West of Scotland Coronary Prevention Study (WOSCOPS) is a randomized, double-blind, placebo-controlled trial of pravastatin in a primary prevention context. The primary end point of the trial is definite coronary artery disease (CAD) death and/or nonfatal acute myocardial infarction. This study describes the baseline characteristics of the trial recruits and of the subjects who were screened during the recruitment process; 6,595 men, aged 45 to 64 years, with raised cholesterol levels, were randomized in equal numbers to placebo or pravastatin after initial screening of approximately 81,000 subjects in the West of Scotland. With the exception of cholesterol levels and history of CAD, the recruits had a similar risk factor profile and demographic distribution to the group of screenees from which they were selected. Compared with previous primary prevention studies of cholesterol-lowering drugs, the WOSCOPS recruits are, on average, 7 to 9 years older than subjects in other trials and have average total cholesterol levels 0.5 mmol/L (19.4 mg/dl) lower than those in the Helsinki Heart Study and the Lipid Research Clinics-Coronary Primary Prevention Trial. The study has achieved its initial goal of accumulating > 30,000 patient-years of randomized follow-up. Recruits had their final trial visits in the first half of 1995 and the main results will be available in the fourth quarter of 1995.

摘要

苏格兰西部冠心病预防研究(WOSCOPS)是一项在一级预防背景下使用普伐他汀的随机、双盲、安慰剂对照试验。该试验的主要终点是明确的冠状动脉疾病(CAD)死亡和/或非致命性急性心肌梗死。本研究描述了试验招募对象以及在招募过程中接受筛查的受试者的基线特征;在对苏格兰西部约81,000名受试者进行初步筛查后,6595名年龄在45至64岁、胆固醇水平升高的男性被等数随机分为安慰剂组或普伐他汀组。除胆固醇水平和CAD病史外,招募对象与从中选取他们的筛查对象组具有相似的危险因素概况和人口统计学分布。与以往关于降胆固醇药物的一级预防研究相比,WOSCOPS的招募对象平均比其他试验中的受试者大7至9岁,平均总胆固醇水平比赫尔辛基心脏研究和脂质研究诊所 - 冠心病一级预防试验中的受试者低0.5 mmol/L(19.4 mg/dl)。该研究已实现其最初目标,即积累超过30,000患者年的随机随访。招募对象在1995年上半年进行了最后一次试验访视,主要结果将于1995年第四季度公布。

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