辅酶A和非诺贝特对高脂血症患者的疗效及安全性比较  

Comparison of effects and safety of coenzyme A and fenofibrate in patients 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6期450-455,共6页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的比较口服辅酶A和非诺贝特治疗高脂血症患者的疗效及安全性。方法本研究为随机、双盲、平行对照的多中心Ⅲ期临床试验，417例三酰甘油（TG）为2．3～6．5mmol·L-1的血脂异常患者，随机分为非诺贝特组（n=207）和辅酶A组（n：210），分别每日口服非诺贝特200mg和辅酶A400U，治疗8周。分别于0、4、8周采取血样，测定各项血常规、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，次要疗效指标为总胆固醇（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。并考察非诺贝特和辅酶A的安全性。结果治疗4周后，辅酶A组TG较基线平均下降17-3％，非诺贝特组下降31．6％；治疗8周后．辅酶A组下降23．8％，非诺贝特组下降33．1％，两组比较有显著差异（P〈0．01）。辅酶A组HDL—C升高，但低于非诺贝特组（P〈0．01）。两组治疗后TC和LDL—C水平均无显著差异（P〉0．05）。血清丙氨酸转氯酶、天冬氨酸转氨酶、尿素氮、肌酐水平在辅酶A组治疗后均无变化，而非诺贝特治疗后均有升高，组间比较有显著差异（P〈0．01）。结论辅酶A和非诺贝特均具有降低TG的作用，非诺贝特降TG的作用优于辅酶A，而辅酶A的安全性优于非诺贝特。AIM This study was designed to compare the effects and safety of coenzyme A （CoA） and fenofibrate on plasma lipid levels in the patients with dyslipidemia. METHODS In the prospective,randomized, placebo-controlled, double-blind, multi-centre, phase m clinical trial, 417 patients with hyperlipidemia （TG 2.3 - 6.5 mmol＂ L-j） were randomly divided into two groups and treated with CoA 400 U＇d-1 （n = 210） and fenofibrate 200 mg.d-t （n = 207） respectively for 8 weeks. After 4 weeks and 8 weeks, blood routine, urine routine, hepatic and renal function, blood glucose, blood lipid and creatine kinase were measured. The primary end- point efficacy outcome is the TG lowing efficacy, and the secondary efficacy parameters are variation rate of plasma total cholesterol （TC） , low- density lipoprotein cholesterol （LDL-C） and high- density lipoprotein cholesterol （HDL- C） and adverse events were compared after the treatment. RESULTS After the treatment for 4 weeks TG level reduce 31.6% and 17.3% respectively in the fenofibrate group and the CoA group. After the treatment for 8 weeks, TG was significantly reduced 33.1% and 23.8% in two groups, respectively. The difference between two groups was significantly （P 〈 0.01） . Compared with the fenofibrate group, the increase of HDL-C in the CoA group was lower （P 〈 0.01）. After the treatment, there was no significant difference of LDL- C, TC lowing rate between two groups. There were less drug- related adverse events in the CoA group than in the fenofibrate group, and difference was significant. CONCLUSIONS It was showed that the TG lowing effect of fenofibrate 200 mg.d-1 was better than CoA 400 U＇d-1. But CoA 400 U- d-1 was with better safety and tolerance in the moderate dvslipidemia patients than fenofibrate.

关 键 词：乙酰辅酶A 非诺贝特 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]