【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2.3~6.5 mmol.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200 mg和辅酶A 400 U,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)。血清丙氨酸转氨酶、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。更多还原

【Abstract】 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 Ⅲ clinical trial,417 patients with hyperlipidemia(TG 2.3-6.5 mmol.L-1) were randomly divided into two groups and treated with CoA 400 U.d-1(n = 210) and fenofibrate 200 mg.d-1(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 dyslipidemia patients than fenofibrate.更多还原