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辛伐他汀与普伐他汀对比:原发性高胆固醇血症患者中的疗效与耐受性

Simvastatin versus pravastatin: efficacy and tolerability in patients with primary hypercholesterolemia.

作者信息

Malini P L, Ambrosioni E, De Divitiis O, Di Somma S, Rosiello G, Trimarco B

机构信息

Cattedra di Terapia Medica Sistematica, University of Bologna, Italy.

出版信息

Clin Ther. 1991 Jul-Aug;13(4):500-10.

PMID:1934003
Abstract

One hundred patients with primary hypercholesterolemia (total plasma cholesterol greater than or equal to 6.2 mmol/L [240 mg/dl]) were enrolled in an open, randomized, parallel comparative study of simvastatin and pravastatin. All patients started or continued a standard lipid-lowering diet for at least six weeks prior to entry into the four-week placebo baseline period. Fifty patients received simvastatin and 50 patients received pravastatin, both at the recommended starting dose of 10 mg/day, for a treatment period of six weeks. Total cholesterol levels were reduced by 24% (from 7.59 mmol/L to 5.80 mmol/L) with simvastatin, and by 15% (from 7.48 mmol/L to 6.35 mmol/L) with pravastatin. Low-density-lipoprotein cholesterol levels were reduced by 33% and 22% and high-density-lipoprotein cholesterol levels were increased by 10% and 7% with simvastatin and pravastatin, respectively. Plasma total triglyceride levels were reduced by 12% with simvastatin and by 6% with pravastatin. Adverse experiences were similar between treatment groups and both drugs were well tolerated. No patients were withdrawn from the study due to clinical adverse experiences; one patient in the pravastatin group required a reduction in dose to 5 mg/day due to insomnia. At the recommended starting dose, simvastatin had a significantly greater lipid-lowering effect than pravastatin. These results may have implications for the appropriate lipid-reduction therapy for patients at risk of coronary heart disease.

摘要

100例原发性高胆固醇血症患者(血浆总胆固醇大于或等于6.2 mmol/L [240 mg/dl])被纳入一项辛伐他汀和普伐他汀的开放、随机、平行对照研究。所有患者在进入为期四周的安慰剂基线期之前,开始或继续标准降脂饮食至少六周。50例患者接受辛伐他汀治疗,50例患者接受普伐他汀治疗,均采用推荐起始剂量10 mg/天,治疗期为六周。辛伐他汀使总胆固醇水平降低了24%(从7.59 mmol/L降至5.80 mmol/L),普伐他汀使总胆固醇水平降低了15%(从7.48 mmol/L降至6.35 mmol/L)。辛伐他汀使低密度脂蛋白胆固醇水平分别降低了33%和22%,使高密度脂蛋白胆固醇水平分别升高了10%和7%。辛伐他汀使血浆总甘油三酯水平降低了12%,普伐他汀使血浆总甘油三酯水平降低了6%。治疗组之间的不良事件相似,两种药物耐受性均良好。没有患者因临床不良事件退出研究;普伐他汀组有1例患者因失眠需要将剂量减至5 mg/天。在推荐起始剂量下,辛伐他汀的降脂效果明显优于普伐他汀。这些结果可能对冠心病高危患者的适当降脂治疗具有启示意义。

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