【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。更多还原

【Abstract】 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,phaseⅢclinical 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·d^-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·d^-1 and pantethine 600 mg·d^-1 had the effect on lowing TG with good safety and tolerance in the moderate hyperlipidemia patients,and CoA was better than pantethine.更多还原