Ceska R, Sobra J, Kvasnicka J, Procházková R, Kvasilová M, Haas T
III. interní klinika 1. LF UK a VFN, Praha.
Cas Lek Cesk. 1996 Jul 26;135(13):413-6.
The aim of the study was to approve the hypolipidemic potency of the new drug from the group of fibrate derivates Lipanthyl 200 M(R) (micronized fenofibrate, cps a 200 mg, Laboratoires Fournier, France) in patients with familial hyperlipoproteinemias. The drug has been administered in constant dose of 200 mg daily with the evening meal for three months. Clinical examinations and monitoring of safety laboratory have been performed in addition to complete analysis of lipids, lipoproteins and apolipoproteins during the study.
The group of 30 patients consisted from 14 heterozygotes of familial hypercholesterolemia and 16 patients affected by familial combined hyperlipidemia. Levels of total, HDL- and LDL-cholesterol, triglycerides, apolipoproteins A-I and B and Lp(a) have been measured and concentrations of fibrinogen in plasma as well. Concentration of total cholesterol 8.29 +/- 1.3 mmol/l on the beginning of the study decreased after one and three months of the treatment to 6.94 +/- 1.19 resp. 6.98 +/- 1.21 mmol/l, concentration of triglycerides has been reduced from 2.86 +/- 1.29 mmol/l to 1.70 +/- 0.86 and 1.74 +/- 0.99 mmol/l respectively HDL-cholesterol raised from 1.14 +/- 0.32 mmol/l to 1.27 +/- 0.36 and to 1.34 +/- 0.37 mmol/l in contrast to decrease of LDL-cholesterol 5.88 +/- 1.53 mmol/l on the beginning of the study to 4.87 +/- 1.49 and 4.79 +/- 1.60. Apo B in plasma fall after three month period of the treatment from 1.83 +/- 0.43 g/l to 1.46 +/- 0.47 g/l. On the other hand the concentration of apolipoprotein apo A-I1.20 +/- 0.35 g/l increased to 1.40 +/- 0.32 g/l. Fibrinogen in plasma was reduced from 3.63 +/- 0.69 g/l to 2.77 +/- 0.50 g/l. Also this decrease was statistically significant.
Micronized fenofibrate is a potent hypolipidemic drug with only rare side effects. It is very good tolerated by the patients. Micronized fenofibrate is particularly prescribed for combined hyperlipidemia, however we can use it also in some patients with familial hypercholesterolemia. For to the treatment very resistant hyperlipoproteinemias we should consider combined drug therapy.
本研究的目的是验证新型药物利平脂200 M（微粒化非诺贝特，胶囊剂，每粒200毫克，法国利博福尼制药公司生产）对家族性高脂蛋白血症患者的降血脂效力。该药物以每日200毫克的固定剂量与晚餐同服，共服用三个月。研究期间除了对血脂、脂蛋白和载脂蛋白进行全面分析外，还进行了临床检查和安全实验室监测。
该组30例患者包括14例家族性高胆固醇血症杂合子和16例家族性混合性高脂血症患者。测定了总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯、载脂蛋白A-I、载脂蛋白B和脂蛋白(a)的水平以及血浆纤维蛋白原浓度。研究开始时总胆固醇浓度为8.29±1.3毫摩尔/升，治疗1个月和3个月后分别降至6.94±1.19和6.98±1.21毫摩尔/升；甘油三酯浓度从2.86±1.29毫摩尔/升分别降至1.70±0.86和1.74±0.99毫摩尔/升；高密度脂蛋白胆固醇从1.14±0.32毫摩尔/升升至1.27±0.36和1.34±0.37毫摩尔/升；低密度脂蛋白胆固醇则从研究开始时的5.88±1.53毫摩尔/升降至4.87±1.49和4.79±1.60毫摩尔/升。治疗3个月后血浆载脂蛋白B从1.83±0.43克/升降至1.46±0.47克/升，而载脂蛋白A-I从1.20±0.35克/升升至1.40±0.32克/升。血浆纤维蛋白原从3.63±0.69克/升降至2.77±0.50克/升，这种下降也具有统计学意义。
微粒化非诺贝特是一种强效降血脂药物，副作用罕见，患者耐受性良好。微粒化非诺贝特特别适用于混合性高脂血症，不过也可用于一些家族性高胆固醇血症患者。对于治疗非常难治的高脂蛋白血症，应考虑联合药物治疗。
