Walldius G, Erikson U, Olsson A G, Bergstrand L, Hådell K, Johansson J, Kaijser L, Lassvik C, Mölgaard J, Nilsson S
Department of Internal Medicine, Karolinska Hospital, Stockholm, Sweden.
Am J Cardiol. 1994 Nov 1;74(9):875-83. doi: 10.1016/0002-9149(94)90579-7.
The Probucol Quantitative Regression Swedish Trial tested whether treatment of hypercholesterolemic persons with probucol for 3 years affected femoral atherosclerosis. The primary end point was the change in atheroma volume estimated as change in lumen volume of the femoral artery assessed by quantitative arteriography. Three hundred three patients with visible atherosclerosis were randomized to probucol 0.5 g, twice daily, or to placebo. All patients were given diet and cholestyramine, 8 to 16 g/day. Twenty-nine patients were excluded because of inadequate primary end point measurements. The mean age of the remaining 274 subjects (158 were men) was 55 years. Seventeen percent had intermittent claudication and 24% had angina pectoris. After 3 years, the probucol-treated patients had 17% lower serum cholesterol, 12% lower low-density lipoprotein cholesterol, 24% lower total high-density lipoprotein cholesterol, and 34% lower high-density lipoprotein2 cholesterol levels than control subjects. All lipoprotein differences between the treatment groups remained highly significant during the trial. There was no statistically significant change in lumen volume between the probucol and the control group. Furthermore, there was no difference between the treatment groups with regard to change in arterial edge roughness or amount of aorto-femoral atherosclerosis; neither were there any differences between the treatment groups with regard to change in ST-segment depressions on exercise tests or ankle/arm blood pressure (secondary end points). In the control group, lumen volume increased (p < 0.001) and roughness of the femoral artery decreased (p < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
普罗布考定量回归瑞典试验旨在测试高胆固醇血症患者接受普罗布考治疗3年是否会影响股动脉粥样硬化。主要终点是通过定量动脉造影评估的股动脉管腔容积变化来估计的动脉粥样硬化斑块容积变化。303例有明显动脉粥样硬化的患者被随机分为每日两次服用0.5g普罗布考组或安慰剂组。所有患者均接受饮食治疗和每天8至16g消胆胺治疗。29例患者因主要终点测量不充分而被排除。其余274名受试者(158名男性)的平均年龄为55岁。17%的患者有间歇性跛行,24%的患者有心绞痛。3年后,与对照组相比,接受普罗布考治疗的患者血清胆固醇水平降低17%,低密度脂蛋白胆固醇水平降低12%,总高密度脂蛋白胆固醇水平降低24%,高密度脂蛋白2胆固醇水平降低34%。在试验期间,治疗组之间所有脂蛋白差异均高度显著。普罗布考组和对照组之间管腔容积无统计学显著变化。此外,治疗组之间在动脉边缘粗糙度变化或主-股动脉粥样硬化程度方面无差异;在运动试验中ST段压低变化或踝/臂血压(次要终点)方面,治疗组之间也无差异。在对照组中,管腔容积增加(p<0.001),股动脉粗糙度降低(p<0.05)。(摘要截短至250字)