辅酶A和泛硫乙胺对高脂血症患者的疗效比较  

Comparison of effects of coenzyme A and pantethine in patient with dyslipidemia

作　　者：赵水平[1] 陈雅琴[1] 陈君柱[2] 来江涛[2] 

机构地区：[1]中南大学湘雅二医院心内科,湖南长沙410011 [2]浙江大学医学院附属第一医院心内科,浙江杭州310003

出　　处：《中国新药与临床杂志》2013年第1期42-46,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的研究口服辅酶A和泛硫乙胺治疗高脂血症患者的疗效比较。方法本研究为随机、双盲、平行对照的多中心Ⅲ期临床试验,223例三酰甘油(TG)2.3～6.5 mmol·L^(-1)的高脂血症患者,随机分为辅酶A组(n=114)和泛硫乙胺组(n=109),分别每日口服辅酶A 400 U和泛硫乙胺600 mg,治疗8周。分别于第0、4、8周采血,测定血常规、血脂参数、尿常规、肝功能、肾功能、肌酸激酶和血糖。主要终点疗效指标为治疗前后TG的变化率,总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)的变化率。并考察辅酶A和泛硫乙胺的安全性。结果治疗4周后,辅酶A组和泛硫乙胺组TG分别下降26.0%和17.4%;治疗8周后,分别下降33.3%和16.5%,两组间差异非常显著(P<0.01)。治疗8周后辅酶A组TC下降率高于泛硫乙胺组,有显著差异(P<0.05),两组间LDL-C和HDL-C及不良反应发生率均无显著差异(P>0.05)。结论泛硫乙胺和辅酶A均能降低TG,辅酶A作用优于泛硫乙胺,安全性良好。AIM To compare the effects of coenzyme A （CoA） and pantethine on plasma lipid levels in Chinese patients with moderate hyperlipidemia. METHODS In the prospective, randomized, double-blind, multi-centre, phase Ili clinical trial, 223 patients with hyperlipidemia （triglyceride （TG） 2.3 - 6.5 mmol·L^-1） were randomly received CoA 400 U＇d-1 （po, n = 118） and pantethine 600 mg·L^-1 （po, n = 118） for 8 weeks.After 4 weeks and 8 weeks, blood routine, urine routine, hepatic function, renal function, blood glucose, blood lipid and creatine kinase were measured. The primary end point was the percentage change in TG from baseline to 4 weeks and 8 weeks, and the secondary efficacy parameters were variation rates of plasma total cholesterol （ TC）, low - density lipoprotein cholesterol （ LDL - C） and high - density lipoprotein cholesterol （HDL-C） . Adverse events were compared in two groups after the treatment. RESULTS After the treatment for 4 weeks, TG levels of the CoA group and the pantethine group were reduced 26.0% and 17.4% respectively, with 33.3% and 16.5% after 8 weeks treatment. The difference between two groups was significant （P 〈 0.01）. Compared with the pantethine group, the reduction rate of TC in the CoA group was higher （P 〈 0.05）. After the treatment, there was no significant difference of LDL-C and HDL-C between two groups （P 〉 0.05） . There was also no significant difference of drug- related adverse event rates between two groups （P 〉 0.05）. CONCLUSIONS CoA 400 U ·L^-1 and pantethine 600 mg·L^-1 had the effect on lowing TG with good safety and tolerance in the moderate hyperlipidemia patients, and CoA was better than pantethine.

关 键 词：乙酰辅酶A 泛硫乙胺 血脂异常 高三酰甘油血症 药物不良反应 随机对照试验 多中心研究 

分 类 号：R541.4[医药卫生—心血管疾病]