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辅酶 A 对高脂血症患者血脂的影响:多中心临床试验结果。

The effects of coenzyme A on serum lipids in patients with hyperlipidemia: results of a multicenter clinical trial.

机构信息

Cardiology Department, The Second Xiangya Hospital, Central South University, Changsha 410011, Hunan, People's Republic of China.

出版信息

J Clin Endocrinol Metab. 2013 Feb;98(2):E275-8. doi: 10.1210/jc.2012-2702. Epub 2013 Jan 4.

DOI:10.1210/jc.2012-2702
PMID:23293333
Abstract

OBJECTIVES

The aim of the study was to evaluate the lipid-lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A (CoA) capsule, in Chinese patients with moderate dyslipidemia.

METHODS

A total of 244 subjects (170 males and 74 females; aged 18-75 y) having moderate dyslipidemia (triglyceride [TG], 2.3-6.5 mmol · L(-1)) were randomly divided into 3 groups, to which placebo (group A, n = 81), CoA 200 U/d (group B, n = 79), and CoA 400 U/d (group C, n = 84) were administered, respectively. Blood lipoproteins, liver and renal functions, blood glucose, and complete blood count were measured at the baseline and after 4 or 8 weeks of treatment.

RESULTS

After treatment for 4 weeks, TG was reduced by 5.1, 15.7, and 14.4% in groups A, B, and C, respectively. After treatment for 8 weeks, TG decreased .9, 21.7, and 36.1%, respectively. Compared with group A, the primary efficacy outcome TG in groups B and C significantly decreased (P < .01), and the difference between groups B and C was also significant (P < .01). Plasma total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were not significantly different. Furthermore, there was no difference in blood glucose, hepatic and renal function test parameters, incidence of myopathy, or gastrointestinal tract symptoms among the 3 groups.

CONCLUSION

CoA can effectively reduce plasma TG levels in subjects with moderate dyslipidemia and has no obvious adverse effect.

摘要

目的

本研究旨在评估一种天然降脂化合物辅酶 A(CoA)胶囊对中国中度血脂异常患者的降脂作用和临床安全性。

方法

共有 244 例(170 名男性和 74 名女性;年龄 18-75 岁)中度血脂异常(甘油三酯 [TG] 2.3-6.5mmol·L(-1))患者被随机分为 3 组,分别给予安慰剂(A 组,n=81)、CoA 200U/d(B 组,n=79)和 CoA 400U/d(C 组,n=84)。在基线和治疗 4 或 8 周后测量血脂蛋白、肝肾功能、血糖和全血细胞计数。

结果

治疗 4 周后,A、B 和 C 组 TG 分别降低 5.1%、15.7%和 14.4%。治疗 8 周后,TG 分别降低 9.0%、21.7%和 36.1%。与 A 组相比,B 组和 C 组的主要疗效指标 TG 显著降低(P<0.01),且 B 组与 C 组之间的差异也有统计学意义(P<0.01)。血浆总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇无显著差异。此外,3 组间血糖、肝肾功能检查参数、肌病发生率和胃肠道症状无差异。

结论

CoA 可有效降低中度血脂异常患者的血浆 TG 水平,且无明显不良反应。

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