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辛伐他汀与普伐他汀治疗原发性高胆固醇血症患者的交叉试验

Crossover trial of simvastatin versus pravastatin in patients with primary hypercholesterolemia.

作者信息

Sasaki S, Sawada S, Nakata T, Itoh H, Takeda K, Nakagawa M, Kuriyama K

机构信息

Second Department of Medicine, Kyoto Prefectural University of Medicine, Japan.

出版信息

J Cardiovasc Pharmacol. 1997 Jul;30(1):142-7. doi: 10.1097/00005344-199707000-00021.

Abstract

The effects of simvastatin and pravastatin administered alone at initial doses of 5 and 10 mg/day, respectively, on normalization of abnormal lipid metabolism in patients with hypercholesterolemia were evaluated by a crossover method. Patients whose serum levels of total cholesterol (TC) were > or = 220 mg/dl were randomly divided into two groups, and one of the groups (group S-P: 17 patients) was treated with simvastatin first and then with pravastatin whereas the other group (group P-S: 19 patients) was treated with pravastatin first and then with simvastatin. Simvastatin or pravastatin was replaced with the other drug after 8-week administration in each group. These drugs were administered for 8 weeks each. Simvastatin and pravastatin significantly reduced the following serum lipids as compared with the levels in the observation period: TC by 23.2 +/- 8.1% and 18.1 +/- 10.9%, triglyceride (TG) by 13.0 +/- 24.7% and 5.8 +/- 47.1%, and low-density lipoprotein cholesterol (LDL-C) by 31.3 +/- 10.1% and 23.1 +/- 14.3%, respectively. TC and LDL-C levels were significantly (p < 0.001) lower and decreased to significantly (p < 0.001) greater degrees after simvastatin treatment than after pravastatin treatment. TC was normalized in 77.8% of the patients (28 of 36) after simvastatin treatment and in 68.9% of the patients (23 of 36) after pravastatin treatment. LDL-C was normalized in 63.9% of the patients (23 of 36) after simvastatin treatment and in 44.4% of the patients (16 of 36) after pravastatin treatment. The percentage of patients whose LDL-C was normalized by simvastatin was significantly (p < 0.05) higher as compared with pravastatin. Results of this trial, which was conducted by a crossover method, show that the initial dose of simvastatin reduces serum cholesterol and LDL-C more potently than the initial dose of pravastatin in patients with hypercholesterolemia.

摘要

采用交叉试验方法评估了辛伐他汀和普伐他汀分别以初始剂量5毫克/天和10毫克/天单独给药对高胆固醇血症患者异常脂质代谢正常化的影响。血清总胆固醇(TC)水平≥220毫克/分升的患者被随机分为两组,其中一组(S-P组:17例患者)先接受辛伐他汀治疗,然后接受普伐他汀治疗,而另一组(P-S组:19例患者)先接受普伐他汀治疗,然后接受辛伐他汀治疗。每组给药8周后,将辛伐他汀或普伐他汀换为另一种药物。每种药物均给药8周。与观察期水平相比,辛伐他汀和普伐他汀显著降低了以下血脂水平:TC分别降低23.2±8.1%和18.1±10.9%,甘油三酯(TG)分别降低13.0±24.7%和5.8±47.1%,低密度脂蛋白胆固醇(LDL-C)分别降低31.3±10.1%和23.1±14.3%。辛伐他汀治疗后TC和LDL-C水平显著更低(p<0.001),且降低幅度显著更大(p<0.001)。辛伐他汀治疗后77.8%的患者(36例中的28例)TC恢复正常,普伐他汀治疗后68.9%的患者(36例中的23例)TC恢复正常。辛伐他汀治疗后63.9%的患者(36例中的23例)LDL-C恢复正常,普伐他汀治疗后44.4%的患者(36例中的16例)LDL-C恢复正常。与普伐他汀相比,辛伐他汀使LDL-C恢复正常的患者百分比显著更高(p<0.05)。该交叉试验结果表明,在高胆固醇血症患者中,辛伐他汀初始剂量比普伐他汀初始剂量更有效地降低血清胆固醇和LDL-C。

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