Rouffy J, Sauvanet J P, Chanu B, Bakir R, Goy-Loeper J, Saya C, Pinaroli F
Nouv Presse Med. 1980 Dec 22;9(49):3747-51.
In a study started in 1973 and still in progress (1100 patient-years so far) fenofibrate in daily doses of 200-400 mg consistently proved effective, without any loss of activity with time. The drug lowered serum total cholesterol levels by 17-27% in type IIa, IIb and III primary hyperlipoproteinaemia (HLP) and serum triglyceride levels by 35-51% in type IIb and III HLP and by 46-54% in type IV HLP. Clinically and biologically fenofibrate was always well tolerated, even after 5 years' treatment. Side-effects were uncommon (4%) and mild, and they obliged to discontinue treatment in only 1% of the patients. Abnormal manifestations encountered during therapy appeared to be fortuitous. The effects of the drug on cardiovascular morbidity and mortality could not be determined from this trial. In a short-term study involving 21 patients with type IIa and IIb primary HLP, fenofibrate in doses of 200-400 mg/day produced a significant decrease in total cholesterol, LDL-cholesterol and apoprotein B. It is also reduced triglycerides and VLDL-triglycerides in type IIb HLP. The increase in HDL-cholesterol observed under fenofibrate was significant in type IIa HLP but not in type IIb HLP. In both types, there was a significant rise in HDL: LDL + VLDL ratio.
在一项始于1973年且仍在进行中的研究(迄今为止已有1100患者年)中,每日剂量为200 - 400毫克的非诺贝特始终被证明是有效的,且未随时间出现活性丧失。该药物使IIa型、IIb型和III型原发性高脂蛋白血症(HLP)患者的血清总胆固醇水平降低了17 - 27%,使IIb型和III型HLP患者的血清甘油三酯水平降低了35 - 51%,使IV型HLP患者的血清甘油三酯水平降低了46 - 54%。在临床和生物学上,非诺贝特始终耐受性良好,即使经过5年治疗也是如此。副作用并不常见(4%)且轻微,仅1%的患者因副作用而不得不停止治疗。治疗期间遇到的异常表现似乎是偶然的。该试验无法确定该药物对心血管发病率和死亡率的影响。在一项涉及21例IIa型和IIb型原发性HLP患者的短期研究中,每天服用200 - 400毫克非诺贝特可使总胆固醇、低密度脂蛋白胆固醇和载脂蛋白B显著降低。它还可降低IIb型HLP患者的甘油三酯和极低密度脂蛋白甘油三酯。在非诺贝特治疗下观察到的高密度脂蛋白胆固醇升高在IIa型HLP患者中显著,但在IIb型HLP患者中不显著。在这两种类型中,高密度脂蛋白:低密度脂蛋白 + 极低密度脂蛋白的比值均显著升高。