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冠心病患者隔日与每日服用阿托伐他汀的随机对照研究

Alternate-day versus daily atorvastatin in coronary artery disease: a randomized study.

作者信息

Rifaie Osama, Zahran Ahmed, Nammas Wail

机构信息

Department of Cardiology, Faculty of Medicine, Ain Shams University, Cairo-Egypt.

出版信息

Anadolu Kardiyol Derg. 2012 Mar;12(2):90-6. doi: 10.5152/akd.2012.032. Epub 2012 Jan 26.

DOI:10.5152/akd.2012.032
PMID:22281786
Abstract

OBJECTIVE

We sought to compare the effect of alternate-day versus daily atorvastatin 10 mg, on serum low-density lipoprotein cholesterol (LDL-C) and high-sensitivity C-reactive protein (hs-CRP) in patients with coronary artery disease (CAD) and controlled serum LDL-C by daily atorvastatin.

METHODS

The study was prospective, randomized, single-blinded, two-armed. Randomization was performed by a computer-generated randomization list. We randomized 60 patients with CAD and controlled serum LDL-C to receive either atorvastatin in the standard-dose of 10 mg daily (Group A=30 patients), or the same medication every other day (Group B=30 patients). Primary efficacy criterion included changes in serum LDL-C and hs-CRP from the initial to the 6-week follow-up values.

RESULTS

The mean age was 54.5±7.7 years, (70% males). LDL-C was significantly lower in Group A as compared with group B at 6-week follow-up (88±21 versus 105±26 mg/dl, respectively, p=0.008). Similarly, the mean percent increase of LDL-C from baseline to final assessment was significantly lower in Group A as compared with Group B (1.5±0.2 versus 32.8±6.2%, respectively, p<0.0001). However, the mean percent change of hs-CRP value was statistically similar between the two groups (p=0.108). Patients reported no side effects attributable to the medication.

CONCLUSION

The current pilot study demonstrated that in patients with CAD who have achieved target LDL-C level, maintenance on alternate-day atorvastatin 10 mg was inferior to daily atorvastatin in keeping LDL-C below the target level; however, it produced a similar effect on hs-CRP.

摘要

目的

我们试图比较隔日服用与每日服用10毫克阿托伐他汀对冠心病(CAD)患者血清低密度脂蛋白胆固醇(LDL-C)和高敏C反应蛋白(hs-CRP)的影响,且这些患者通过每日服用阿托伐他汀使血清LDL-C得到控制。

方法

本研究为前瞻性、随机、单盲、双臂试验。随机分组通过计算机生成的随机列表进行。我们将60例患有CAD且血清LDL-C得到控制的患者随机分为两组,一组接受标准剂量每日10毫克阿托伐他汀治疗(A组 = 30例患者),另一组隔日服用相同药物(B组 = 30例患者)。主要疗效标准包括从初始到6周随访时血清LDL-C和hs-CRP的变化。

结果

平均年龄为54.5±7.7岁,(男性占70%)。在6周随访时,A组的LDL-C显著低于B组(分别为88±21与105±26毫克/分升,p = 0.008)。同样,从基线到最终评估时,A组LDL-C的平均百分比增幅显著低于B组(分别为1.5±0.2与32.8±6.2%,p<0.0001)。然而,两组之间hs-CRP值的平均百分比变化在统计学上相似(p = 0.108)。患者报告未出现与药物相关的副作用。

结论

当前的初步研究表明,在已达到LDL-C目标水平的CAD患者中,隔日服用10毫克阿托伐他汀在使LDL-C保持在目标水平以下方面不如每日服用阿托伐他汀;然而,它对hs-CRP产生了类似的影响。

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