Knipscheer H C, Nurmohamed M T, Van den Ende A, Plaat B, Pruijs H J, Mulder W J, Kastelein J J
Centre for Thrombosis, Haemostasis, Atherosclerosis and Inflammation Research, University of Amsterdam, Netherlands.
J Intern Med. 1994 Oct;236(4):377-84. doi: 10.1111/j.1365-2796.1994.tb00813.x.
To study the short-term efficacy, tolerability and safety of the treatment with gemfibrozil 600 mg twice daily or placebo in male patients with established atherosclerosis, with a lipid profile matching the 'high triglyceride-low high-density lipoprotein (HDL) cholesterol trait'.
Double-blind randomized placebo controlled prospective trial.
Amsterdam Lipid Research Clinic at the Academic Medical Centre of the University of Amsterdam and the Slotervaart Training Hospital affiliated to the University of Amsterdam, Amsterdam, the Netherlands.
Thirty-five male patients, age 30-70, with established atherosclerosis and the high triglyceride-low HDL cholesterol trait.
Plasma total cholesterol, triglycerides, lipoproteins, apolipoproteins A1 and B100, clinical and laboratory safety parameters.
Seventeen patients in the gemfibrozil group and 16 patients in the placebo group completed the study period. Compliance was considered adequate. Mean (+/- standard deviation) plasma HDL cholesterol levels increased 20.3% (+/- 12.22) from 0.82 to 0.99 mmol L-1 in the gemfibrozil group against 9.9% (+/- 18.31) from 0.79 to 0.87 mmol L-1 in the placebo group (P = 0.001). Mean plasma triglyceride level fell 49.5% (+/- 14.27) from 3.65 to 1.82 mmol L-1 in the gemfibrozil group against an increase of 13.6% (+/- 40.31) from 3.62 to 4.01 mmol L-1 in the placebo group (P < 0.001). Although plasma HDL cholesterol and triglyceride levels improved in all patients, normalization of these lipoproteins was only observed in approximately half of them. Plasma total and low-density lipoprotein (LDL) cholesterol levels, as well as plasma levels of apolipoprotein (apo) A1, B100 and lipoprotein [Lp(a)], did not show significant alterations compared to the placebo. All safety parameters were comparable between the two groups and remained within the reference limits. Gemfibrozil was well tolerated during treatment. Minor inconveniences were equally distributed between the two treatment groups.
Gemfibrozil is an effective and safe drug in patients with coronary heart disease (CHD) and the high triglyceride-low HDL cholesterol trait.
研究每日两次服用600毫克吉非贝齐或安慰剂对患有动脉粥样硬化且血脂谱符合“高甘油三酯-低高密度脂蛋白（HDL）胆固醇特征”的男性患者的短期疗效、耐受性和安全性。
双盲随机安慰剂对照前瞻性试验。
荷兰阿姆斯特丹大学学术医疗中心的阿姆斯特丹脂质研究诊所以及阿姆斯特丹大学附属的斯洛特韦尔特拉宁医院。
35名年龄在30至70岁之间、患有动脉粥样硬化且具有高甘油三酯-低HDL胆固醇特征的男性患者。
血浆总胆固醇、甘油三酯、脂蛋白、载脂蛋白A1和B100、临床和实验室安全参数。
吉非贝齐组17名患者和安慰剂组16名患者完成了研究期。依从性被认为是足够的。吉非贝齐组血浆HDL胆固醇水平平均（±标准差）从0.82毫摩尔/升升至0.99毫摩尔/升，增幅为20.3%（±12.22），而安慰剂组从0.79毫摩尔/升升至0.87毫摩尔/升，增幅为9.9%（±18.31）（P = 0.001）。吉非贝齐组血浆甘油三酯水平平均从3.65毫摩尔/升降至1.82毫摩尔/升，降幅为49.5%（±14.27），而安慰剂组从3.62毫摩尔/升升至4.01毫摩尔/升，增幅为13.6%（±40.31）（P < 0.001）。尽管所有患者的血浆HDL胆固醇和甘油三酯水平均有所改善，但只有约一半患者的这些脂蛋白恢复正常。与安慰剂相比，血浆总胆固醇和低密度脂蛋白（LDL）胆固醇水平以及血浆载脂蛋白（apo）A1、B100和脂蛋白[Lp(a)]水平未显示出显著变化。两组的所有安全参数相当，且均保持在参考范围内。治疗期间吉非贝齐耐受性良好。轻微不便在两个治疗组中分布均匀。
对于患有冠心病（CHD）且具有高甘油三酯-低HDL胆固醇特征的患者，吉非贝齐是一种有效且安全的药物。
