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舒洛地尔的降胆固醇活性:双盲、交叉短期和长期治疗试验

Hypocholesterolaemic activity of suloctidil: double-blind, crossover short-term and long-term treatment trial.

作者信息

Chieffo C, Postiglione A, Tritto C, Mancini M

出版信息

Curr Med Res Opin. 1984;9(3):147-52. doi: 10.1185/03007998409109573.

Abstract

Two studies were carried out in patients with primary hyperlipidaemia to investigate the effect of suloctidil (200 mg 3-times daily) on serum cholesterol levels and other lipidaemic variables. The first study was a double-blind, crossover comparison of suloctidil and placebo in 23 patients. Patients were allocated at random to receive one or other treatment for 4 weeks, after a wash-out period of 4 weeks on placebo, and were then crossed over to the alternative medication for the following 4 weeks. Patients were kept on a controlled diet throughout the trial. In the second, long-term study, 28 patients were treated, after an initial washout period of 8 weeks on placebo, with suloctidil for periods of up to 1 year. As in the short-term trial, patients were maintained on a controlled diet. The results showed that suloctidil produced a statistically significant reduction in total serum cholesterol and serum triglycerides in the short-term and this reduction was maintained over the longer period of the second study. In addition, there was a concomitant and approximately proportional increase in HDL-cholesterol. Suloctidil was well tolerated and no serious side-effects were reported.

摘要

开展了两项针对原发性高脂血症患者的研究,以调查舒洛地尔(每日3次,每次200毫克)对血清胆固醇水平及其他血脂变量的影响。第一项研究是在23名患者中进行的舒洛地尔与安慰剂的双盲交叉比较。患者被随机分配接受其中一种治疗4周,在经过4周的安慰剂洗脱期后,再交叉接受另一种药物治疗4周。在整个试验过程中,患者保持控制饮食。在第二项长期研究中,28名患者在经过8周的安慰剂初始洗脱期后,接受舒洛地尔治疗长达1年。与短期试验一样,患者保持控制饮食。结果显示,舒洛地尔在短期内使总血清胆固醇和血清甘油三酯出现了具有统计学意义的降低,并且在第二项研究的较长时间段内这种降低得以维持。此外,高密度脂蛋白胆固醇有相应的、近似成比例的升高。舒洛地尔耐受性良好,未报告严重副作用。

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