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维生素 D 对高胆固醇血症他汀类药物治疗患者血浆脂质谱的影响:一项随机安慰剂对照试验。

Effects of vitamin D on plasma lipid profiles in statin-treated patients with hypercholesterolemia: A randomized placebo-controlled trial.

机构信息

Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Henan Province, China.

Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Henan Province, China.

出版信息

Clin Nutr. 2015 Apr;34(2):201-6. doi: 10.1016/j.clnu.2014.04.017. Epub 2014 May 2.

DOI:10.1016/j.clnu.2014.04.017
PMID:24844869
Abstract

BACKGROUND & AIMS: Lipid abnormalities are regarded as a risk factor for cardiovascular disease. Low vitamin D status has been shown to be associated with hyperlipidemia. We planned to research the effects of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.

METHODS

Patients with hypercholesterolemia were enrolled in this single-center, double-blind, placebo-controlled trial in Beijing (39°54' N). Fifty-six patients were randomly assigned to receive vitamin D (n = 28, 2000 IU/d) or a placebo (n = 28) as an add-on to statin, by the method of permutated block randomization. Serum lipid levels were evaluated at baseline, 1, 3 and 6 months.

RESULTS

Vitamin D supplementation resulted in increased serum 25-hydroxyvitamin D concentrations compared with placebo (+16.3 ± 11.4 compared with +2.4 ± 7.1 ng/ml; p < 0.001). At 6 months, the primary end point, a difference in the fall of serum total cholesterol levels between the vitamin D and placebo groups after 6 months of treatment was significant -22.1 mg/dl (95% CI -32.3; -12.2) (p < 0.001). The difference between the groups in the fall of serum triglyceride levels after 6 months of treatment was -28.2 mg/dl (95% CI -48.8; -8.4) (p < 0.001). In patients with 25-hydroxyvitamin D level<30 ng/ml at baseline (n = 43), the serum total cholesterol and triglyceride levels were reduced by -28.5 ± 11.9 mg/dl (p < 0.001) and -37.1 ± 19.5 mg/dl (p < 0.001), respectively.

CONCLUSIONS

Vitamin D supplementation might improve serum lipid levels in statin-treated patients with hypercholesterolemia, it might be an adjuvant therapy for patients with hypercholesterolemia. Clinical Trials Registration Number - NCT02009787.

摘要

背景与目的

脂质异常被认为是心血管疾病的危险因素。维生素 D 状态低下与高脂血症有关。我们计划研究维生素 D 补充作为高胆固醇血症患者辅助治疗的效果。

方法

在北京(北纬 39°54')进行了这项单中心、双盲、安慰剂对照试验,纳入了高胆固醇血症患者。56 名患者被随机分配接受维生素 D(n = 28,2000 IU/d)或安慰剂(n = 28)作为他汀类药物的附加治疗,采用随机区组置换法分组。在基线、1、3 和 6 个月时评估血清脂质水平。

结果

与安慰剂相比,维生素 D 补充使血清 25-羟维生素 D 浓度升高(增加 16.3 ± 11.4 比增加 2.4 ± 7.1 ng/ml;p < 0.001)。6 个月时,主要终点是治疗 6 个月后血清总胆固醇水平下降,维生素 D 组与安慰剂组之间的差异有统计学意义(-22.1 mg/dl,95%CI-32.3;-12.2)(p < 0.001)。治疗 6 个月后血清甘油三酯水平下降,两组之间的差异为-28.2 mg/dl(95%CI-48.8;-8.4)(p < 0.001)。在基线时 25-羟维生素 D 水平<30 ng/ml 的患者(n = 43)中,血清总胆固醇和甘油三酯水平分别降低了-28.5 ± 11.9 mg/dl(p < 0.001)和-37.1 ± 19.5 mg/dl(p < 0.001)。

结论

维生素 D 补充可能改善他汀类药物治疗的高胆固醇血症患者的血清脂质水平,可能是高胆固醇血症患者的辅助治疗。临床试验注册号:NCT02009787。

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