Smit J W, Wijnne H J, Schobben F, Sitsen A, De Bruin T W, Erkelens D W
Department of Internal Medicine, University Hospital, Utrecht, The Netherlands.
Ann Intern Med. 1995 May 1;122(9):678-80. doi: 10.7326/0003-4819-122-9-199505010-00006.
To determine the effects of fluvastatin, a synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, combined with moderate alcohol consumption on lipid profiles and hepatic function in patients with primary hypercholesterolemia.
Randomized, placebo-controlled, crossover study.
Lipid clinic of a university hospital.
31 patients with primary hypercholesterolemia (low-density lipoprotein cholesterol levels > or = 4.2 mmol/L) who had previously received a lipid-lowering diet.
After a dietary baseline period, 26 patients were randomly assigned to receive 6 weeks of treatment with either 1) fluvastatin, 40 mg/d, added to 20 g of ethanol and diluted to 20% with orange juice or 2) fluvastatin added to orange juice alone. After a 6-week washout period, the two groups crossed over.
Plasma fluvastatin levels, lipid levels, and clinical variables were determined at the end of each treatment period.
Six patients left the study prematurely. The remaining patients (15 men, 5 women; mean age +/- SD 49.1 +/- 14.5 years; mean body mass index +/- SD 24.5 +/- 2.2 kg/m2) completed the study. Fluvastatin, alone and combined with alcohol, resulted in similar decreases in levels of total cholesterol (22% and 23%, respectively; P < 0.001 when compared with baseline), low-density lipoprotein cholesterol (28% and 29%, respectively; P < 0.001 compared with baseline), and apolipoprotein B (17% and 20%, respectively; P < 0.001 compared with baseline). High-density lipoprotein cholesterol and triglyceride levels were not changed. Fluvastatin with alcohol resulted in a significantly greater area under the plasma concentration curve (23.4 +/- 4.7 compared with 18.2 +/- 3.2 x 10(3) ng.min/mL) and in a greater time to maximum concentration (187.5 +/- 16.6 min compared with 130.9 +/- 7.0 min) than fluvastatin alone. Terminal half-life tended to increase. No important adverse clinical effects were observed.
Six weeks of daily, moderate alcohol consumption influenced the metabolism of fluvastatin but did not interfere with its lipid-lowering efficacy and had no adverse effects.
确定合成的3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂氟伐他汀联合适度饮酒对原发性高胆固醇血症患者血脂谱和肝功能的影响。
随机、安慰剂对照、交叉研究。
大学医院的脂质门诊。
31例原发性高胆固醇血症患者（低密度脂蛋白胆固醇水平≥4.2 mmol/L），此前接受过降脂饮食。
在饮食基线期后，26例患者被随机分配接受6周治疗，治疗方案为：1）氟伐他汀40 mg/d，加入20 g乙醇，并用橙汁稀释至20%；或2）氟伐他汀仅加入橙汁。经过6周的洗脱期后，两组交叉治疗。
在每个治疗期结束时测定血浆氟伐他汀水平、血脂水平和临床变量。
6例患者提前退出研究。其余患者（15例男性，5例女性；平均年龄±标准差49.1±14.5岁；平均体重指数±标准差24.5±2.2 kg/m2）完成了研究。单独使用氟伐他汀以及联合饮酒，均可使总胆固醇水平（分别降低22%和23%；与基线相比，P<0.001）、低密度脂蛋白胆固醇水平（分别降低28%和29%；与基线相比，P<0.001）和载脂蛋白B水平（分别降低17%和20%；与基线相比，P<0.001）出现相似程度的下降。高密度脂蛋白胆固醇和甘油三酯水平未发生变化。与单独使用氟伐他汀相比，联合饮酒时血浆浓度曲线下面积显著增大（分别为23.4±4.7与18.2±3.2×ng.min/mL），达峰时间延长（分别为187.5±16.6分钟与130.9±7.0分钟）。终末半衰期有延长趋势。未观察到重要的不良临床影响。
每日适度饮酒6周会影响氟伐他汀的代谢，但不干扰其降脂疗效，且无不良影响。
