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普伐他汀治疗原发性高胆固醇血症:一项瑞士多中心研究

[Pravastatin in the treatment of primary hypercholesterolemia: a Swiss multicenter study].

作者信息

Ferrari P, Weidmann P, Riesen W F, Martius F, Luban S, Pasotti E, Erne P, Fragiacomo C, Noseda G, Reutter F

机构信息

Medizinische Universitäts-Poliklinik, Bern.

出版信息

Schweiz Med Wochenschr. 1993 Sep 18;123(37):1736-41.

PMID:8211024
Abstract

Conventional lipid-lowering agents displayed only limited efficacy in lowering total and LDL cholesterol and a high incidence of side effects. Pravastatin is a new potent cholesterol-lowering agent, which selectively inhibits hepatic HMG-CoA-reductase. In a double-blind, placebo-controlled Swiss multicenter study with determination of lipids and lipoprotein in a central laboratory, the efficacy and safety of 6 months' therapy with pravastatin was evaluated in 50 patients with mild hypercholesterolemia and additional coronary risk factors. Compared to baseline and after 26 weeks' therapy, pravastatin significantly reduced total cholesterol (pravastatin vs placebo, -17% vs +7%, p < 0.0001) and LDL cholesterol (-26 vs +2%, p < 0.0001). The total/HDL cholesterol ratio ( = "atherogenic index") was comparable in the two groups at baseline (5.9 +/- 1.1 vs 6.3 +/- 0.9), and was distinctly lowered by pravastatin but not placebo (-20 vs 0%, p < 0.0001). In 11 patients in whom the reduction of serum total cholesterol after 13 weeks' treatment with 20 mg pravastatin was still below target (on average -9.1%), doubling of the dose produced a further decrease of 4.3%. Serum HDL cholesterol and serum triglyceride levels did not change significantly during pravastatin treatment as compared to baseline and placebo. Pravastatin was well tolerated during the 26 weeks without relevant subjective side-effects. There were 5 dropouts during the study, 2 patients in the pravastatin group and 3 in the placebo group. These findings document that pravastatin, administered in a single daily dose of 20 to 40 mg, effectively lowers serum cholesterol and total-/HDL-cholesterol improving action and is well tolerated.

摘要

传统的降脂药物在降低总胆固醇和低密度脂蛋白胆固醇方面疗效有限,且副作用发生率高。普伐他汀是一种新型强效降脂药物,它能选择性抑制肝脏羟甲基戊二酸单酰辅酶A还原酶。在一项由瑞士多中心开展的双盲、安慰剂对照研究中,由中央实验室测定血脂和脂蛋白,对50例患有轻度高胆固醇血症且伴有其他冠心病危险因素的患者进行了为期6个月的普伐他汀治疗效果及安全性评估。与基线水平及治疗26周后相比,普伐他汀显著降低了总胆固醇(普伐他汀组与安慰剂组相比,分别为-17%和+7%,p<0.0001)和低密度脂蛋白胆固醇(分别为-26%和+2%,p<0.0001)。两组基线时的总胆固醇/高密度脂蛋白胆固醇比值(即“致动脉粥样硬化指数”)相当(分别为5.9±1.1和6.3±0.9),普伐他汀组该比值明显降低,而安慰剂组无变化(分别为-20%和0%,p<0.0001)。11例接受20mg普伐他汀治疗13周后血清总胆固醇降低仍未达目标(平均降低9.1%)的患者,将剂量加倍后又进一步降低了4.3%。与基线水平及安慰剂组相比,普伐他汀治疗期间血清高密度脂蛋白胆固醇和血清甘油三酯水平无显著变化。普伐他汀在26周治疗期间耐受性良好,无相关主观副作用。研究期间有5例退出,普伐他汀组2例,安慰剂组3例。这些研究结果表明,每日单次服用20至40mg普伐他汀能有效降低血清胆固醇及总胆固醇/高密度脂蛋白胆固醇比值,改善作用明显,且耐受性良好。

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