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[普伐他汀治疗原发性高胆固醇血症。一项安慰剂对照试验]

[Treatment of primary hypercholesterolemia with pravastatin. A placebo-controlled trial].

作者信息

Frederiksen S M, Larsen M L, Oxenbøll I B, Pindborg T, Haghfelt T

机构信息

Haderslev Sygehus, medicinsk afdeling.

出版信息

Ugeskr Laeger. 1993 Sep 6;155(36):2794-9.

PMID:8236548
Abstract

We present the results of a multicentre, placebo-controlled, randomized double-blind comparison of the treatment of primary hypercholesterolaemia with pravastatin (Pravachol), an HMG-CoA-reductase inhibitor. The study was conducted in both general practice and hospital settings. Two hundred and eighty-six patients who despite oral and written dietary instructions and advice on healthy living had elevated total serum cholesterol levels of between six and eight mmol/l were randomized to treatment with either parvastatin (Pravachol) or placebo. The study showed a significant reduction in both total serum cholesterol (of 16%) and serum LDL-cholesterol among those treated with pravastatin (Pravachol), as well as a small increase tin serum HDL-cholesterol of six percent. Advice on diet and healthy living resulted in a reduction of serum cholesterol of only 1.5%. There were no important differences between those treated from the hospital and those treated in general practice. The incidence of side-effects was low and comparable to placebo levels, and only two percent of the pravastatin (Pravachol) treated patients had to have the treatment stopped. All side-effects were reversible. No side-effects relating to the central nervous system were registered, and no elevations of serum creatinine phosphokinase were observed amongst the pravastatin treated patients, presumably because of the drug's selective inhibitory effect on cholesterol synthesis in the liver.

摘要

我们展示了一项多中心、安慰剂对照、随机双盲研究的结果,该研究比较了HMG-CoA还原酶抑制剂普伐他汀(普拉固)对原发性高胆固醇血症的治疗效果。研究在全科医疗和医院环境中进行。286名患者尽管接受了口头和书面的饮食指导以及健康生活建议,但血清总胆固醇水平仍在6至8 mmol/l之间,他们被随机分为接受普伐他汀(普拉固)或安慰剂治疗。研究表明,接受普伐他汀(普拉固)治疗的患者血清总胆固醇显著降低(降低了16%),血清低密度脂蛋白胆固醇也显著降低,同时血清高密度脂蛋白胆固醇略有升高,升高了6%。饮食和健康生活建议仅使血清胆固醇降低了1.5%。在医院接受治疗的患者和在全科医疗中接受治疗的患者之间没有重要差异。副作用发生率较低,与安慰剂水平相当,只有2%接受普伐他汀(普拉固)治疗的患者不得不停止治疗。所有副作用都是可逆的。未记录到与中枢神经系统相关的副作用,在接受普伐他汀治疗的患者中也未观察到血清肌酸磷酸激酶升高,这可能是由于该药物对肝脏胆固醇合成具有选择性抑制作用。

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