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[非诺贝特250 SR Pharmavit治疗混合性高脂蛋白血症患者。来自捷克共和国13个中心的189例患者的研究结果]

[Fenofibrate 250 SR Pharmavit in patients with mixed hyperlipoproteinemia. Results of a study of 189 patients from 13 centers in the Czech Republic].

作者信息

Ceska R, Stulc T

机构信息

III. interní klinika 1, Praha.

出版信息

Cas Lek Cesk. 2000 Jun 21;139(12):369-73.

Abstract

BACKGROUND

Hyperlipoproteinemia represents one of the major risk factors in the early atherosclerosis manifestation, namely in the ischaemic heart disease. In patients after the myocardial infarction, mixed hyperlipoproteinemia becomes the most frequently diagnosed impairment of the lipid metabolism. In the therapy, fibrates begin to play an important role. A new remedy containing micronised fenofibrate (Fenofibrate 250 SR Pharmavit) was recently registered for the Czech market. The aim of our study was to test its effects in almost 200 patients with mixed hyperlipoproteinemia.

METHODS AND RESULTS

Into statistical analysis of the treatment effectiveness 187 persons (115 males, 72 females) were included. Other characteristics of the studied group (mean +/- SD): age 54.0 +/- 10.7 years, stature 172.0 +/- 8.7 cm, weight, BMI 28.0 +/- 3.1. Prevalence of risk factors and clinical manifestations of the atherosclerosis: ICHS 18.2%, myocardial infarction 7.5%, ICHDK 4.3%, CMP 5.3%, smoking 27.8%, arterial hypertension 63.6%, diabetes mellitus 17.6%, positive family history in ICHS 50.3%. 44.9% persons had been treated with hypolipidemics. Basic parameters of the lipid metabolism, cholesterol, LDL and HDL cholesterol and triglycerides were studied. Plasma levels of uric acid, fibrinogen, glucose and other biochemical parameters were also used to monitor the safeness of the treatment. Cholesterol concentration (7.05 +/- 0.91 mmol/l) decreased (6.14 +/- 0.89 mmol/l) almost by 15%. Triglyceride concentration decrease (from 4.43 +/- 1.84 mmol/l to 2.64 +/- 1.34 mmol/l) was more intensive (41%). HDL-cholesterol increased by almost 15%, while LDL-cholesterol decreased by 12%. Statistically significantly decreased level of the uric acid (12%), fibrinogene decrease (8.4%) reached only marginal significance. Treatment was well tolerated, only in one patient it was necessary to cut it prematurely.

CONCLUSIONS

According clinical tests which included almost 200 patients with mixed hyperlipoproteinemia, Fenofibrate 250 SR Pharmavit stands for an effective and well tolerated hypolipidemics.

摘要

背景

高脂蛋白血症是早期动脉粥样硬化表现(即缺血性心脏病)的主要危险因素之一。在心肌梗死患者中,混合型高脂蛋白血症是最常被诊断出的脂质代谢障碍。在治疗中,贝特类药物开始发挥重要作用。一种含有微粉化非诺贝特(非诺贝特250 SR Pharmavit)的新药最近在捷克市场注册。我们研究的目的是测试其对近200例混合型高脂蛋白血症患者的疗效。

方法与结果

187人(115名男性,72名女性)纳入治疗效果的统计分析。研究组的其他特征(均值±标准差):年龄54.0±10.7岁,身高172.0±8.7厘米,体重,体重指数28.0±3.1。动脉粥样硬化危险因素和临床表现的患病率:缺血性心脏病18.2%,心肌梗死7.5%,缺血性脑血管病4.3%,周围血管病5.3%,吸烟27.8%,动脉高血压63.6%,糖尿病17.6%,缺血性心脏病家族史阳性50.3%。44.9%的人接受过降脂治疗。研究了脂质代谢的基本参数、胆固醇、低密度脂蛋白和高密度脂蛋白胆固醇以及甘油三酯。还使用血浆尿酸、纤维蛋白原、葡萄糖和其他生化参数来监测治疗的安全性。胆固醇浓度(7.05±0.91毫摩尔/升)下降至(6.14±0.89毫摩尔/升),几乎下降了15%。甘油三酯浓度下降更明显(从4.43±1.84毫摩尔/升降至2.64±1.34毫摩尔/升)(41%)。高密度脂蛋白胆固醇增加了近15%,而低密度脂蛋白胆固醇下降了12%。尿酸水平有统计学意义的下降(12%),纤维蛋白原下降(8.4%)仅达到边缘显著性。治疗耐受性良好,仅1例患者需要提前停药。

结论

根据对近200例混合型高脂蛋白血症患者的临床试验,非诺贝特250 SR Pharmavit是一种有效且耐受性良好的降脂药物。

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