Kornitzer M, Dramaix M, Vandenbroek M D, Everaert L, Gerlinger C
Laboratory of Epidemiology and Social Medicine, School of Public Health, Free University of Brussels, Belgium.
Atherosclerosis. 1994 Oct;110 Suppl:S49-54. doi: 10.1016/0021-9150(94)05378-v.
The authors report the results of a large open multicenter study using 200 mg micronised fenofibrate once a day. Among 1545 selected patients who underwent a 3-month period with nutritional advice, 1334 were included in a 6-month drug study. Inclusion criteria were total serum cholesterol equal to or above 250 mg/dl and/or serum triglycerides equal to or above 200 mg/dl. At 6 months, average changes from inclusion levels were -20.5, -26.1. -7.5 and +15.2% for total cholesterol, LDL-cholesterol > or = 160 mg/dl on inclusion, plasma fibrinogen and HDL-cholesterol, respectively. Median decrease of serum triglycerides was 46.5%. Trial discontinuation for clinical and biological adverse events were 5 and 1%, respectively. In conclusion, micronised fenofibrate at a daily dose of 200 mg had significant lipid-modifying properties but also exhibited a beneficial effect on other related risk factors such as fibrinogen reduction. The safety profile was very satisfactory providing an excellent benefit/risk ratio.
作者报告了一项大型开放性多中心研究的结果，该研究使用每日一次200毫克微粒化非诺贝特。在1545名接受了为期3个月营养咨询的选定患者中，1334名被纳入为期6个月的药物研究。纳入标准为血清总胆固醇等于或高于250毫克/分升和/或血清甘油三酯等于或高于200毫克/分升。6个月时，总胆固醇、纳入时低密度脂蛋白胆固醇≥160毫克/分升、血浆纤维蛋白原和高密度脂蛋白胆固醇相对于纳入水平的平均变化分别为-20.5%、-26.1%、-7.5%和+15.2%。血清甘油三酯的中位数下降了46.5%。因临床和生物学不良事件而停药的比例分别为5%和1%。总之，每日剂量200毫克的微粒化非诺贝特具有显著的脂质调节特性，而且对其他相关危险因素如降低纤维蛋白原也显示出有益作用。安全性非常令人满意，效益/风险比极佳。
