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辅酶 A 与非诺贝特治疗高血脂症患者的疗效和安全性:一项多中心、双盲、双模拟、随机临床试验。

Efficacy and safety of coenzyme A versus fenofibrate in patients with hyperlipidemia: a multicenter, double-blind, double-mimic, randomized clinical trial.

机构信息

Department of Cardiology, The Second Xiangya Hospital, Central South University, Changsha, China.

出版信息

Curr Med Res Opin. 2020 Jun;36(6):941-945. doi: 10.1080/03007995.2020.1747416. Epub 2020 Apr 16.

DOI:10.1080/03007995.2020.1747416
PMID:32212983
Abstract

We investigated the lipid-lowering efficacy and safety of coenzyme A (CoA) versus fenofibrate in Chinese patients with moderate dyslipidemia. A total of 417 subjects (aged 18-75 years) diagnosed with moderate dyslipidemia (triglyceride 2.3-6.5 mmol/L) from 13 large cardiovascular centers in China were recruited and randomly divided into a fenofibrate group ( = 207), which received 200 mg of fenofibrate orally once daily, and a CoA group ( = 210), which received 400 mg of CoA orally once a day. Blood lipoproteins, liver and renal function, creatine kinase, and blood glucose were measured at baseline, and after 4 and 8 weeks of treatment. The baseline triglyceride (TG) level in the fenofibrate group and the CoA group was 3.39 ± 0.99 mmol/L and 3.60 ± 1.11 mmol/L, respectively. After treatment for 4 and 8 weeks with fenofibrate, TG was reduced by 31.62% and 33.13%. In the CoA group, TG was reduced by 17.29% and 23.80%. Compared with baseline, total cholesterol (TC) was significantly decreased in both groups after either 4 or 8 weeks of treatment ( < .05). CoA increased high-density lipoprotein cholesterol (HDL-C) after 4 weeks of treatment, whereas it had no significant effect on HDL-C after 8 weeks of treatment. Low-density lipoprotein cholesterol (LDL-C) was not modified in either group. The incidence of side effects was significantly lower in the CoA group compared with the fenofibrate group ( < .05). Compared with fenofibrate, CoA has less effect on reducing plasma TG levels in subjects with moderate dyslipidemia. However, it has fewer adverse effects.

摘要

我们研究了辅酶 A(CoA)与非诺贝特在中国中度血脂异常患者中的降脂疗效和安全性。总共招募了 417 名(年龄 18-75 岁)来自中国 13 个大型心血管中心的中度血脂异常(甘油三酯 2.3-6.5mmol/L)患者,将他们随机分为非诺贝特组(n=207),给予每日一次口服 200mg 非诺贝特;和 CoA 组(n=210),给予每日一次口服 400mg CoA。在基线、治疗 4 周和 8 周时测量血脂蛋白、肝肾功能、肌酸激酶和血糖。非诺贝特组和 CoA 组的基线甘油三酯(TG)水平分别为 3.39±0.99mmol/L 和 3.60±1.11mmol/L。用非诺贝特治疗 4 周和 8 周后,TG 分别降低了 31.62%和 33.13%。在 CoA 组,TG 分别降低了 17.29%和 23.80%。与基线相比,两组在治疗 4 周和 8 周后总胆固醇(TC)均显著降低(<0.05)。CoA 在治疗 4 周后增加了高密度脂蛋白胆固醇(HDL-C),而在治疗 8 周后对 HDL-C 没有显著影响。两组的低密度脂蛋白胆固醇(LDL-C)均未发生改变。与非诺贝特组相比,CoA 组的不良反应发生率显著降低(<0.05)。与非诺贝特相比,CoA 对降低中度血脂异常患者的血浆 TG 水平作用较小,但不良反应较少。

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