辅酶A对高脂血症患者的疗效及安全性

目的研究口服辅酶A治疗高脂血症患者的疗效和安全性。方法本研究为随机、双盲、平行、安慰剂对照的多中心Ⅱ期临床试验,244例三酰甘油(TG)为2.3～6.5 mmol.L-1的高脂血症患者,随机分为安慰剂组(n=81)、辅酶A 200 U.d-1组(n=79)和辅酶A 400 U.d-1(n=84),分别每日口服安慰剂和相应剂量的辅酶A,治疗8 wk。分别于wk 0、4、8测定血常规、血脂参数、尿常规、肝功能、肾功能和血糖。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。并考察辅酶A的安全性。结果治疗4 wk后,安慰剂组、辅酶A 200 U.d-1组和400 U.d-1组TG分别降低5.1%、15.7%和14.4%;治疗8 wk后,3组分别降低0.9%、21.7%和36.1%。辅酶A 200 U.d-1组和400 U.d-1组与治疗前和安慰剂组比较,TG均有显著降低(P<0.01);辅酶A 400 U.d-1组TG降低的幅度明显大于辅酶A 200 U.d-1组(P<0.01)。3组间治疗前后比较,TC、LDL-C和HDL-C均无显著差异(均P>0.05)。3组不良反应发生率无显著差异(P=0.11)。结论辅酶A可有效降低高脂血症患者的TG水平,安全性良好。

Effect and safety of coenzyme A on hyperlipidemia

AIM To evaluate the dose-dependent efficacy and safety of coenzyme A(CoA)capsule in Chinese patients with hyperlipidemia.METHODS In the randomized,placebo-controlled,double-blind,multi-centre,phase Ⅱclinical trial,244 hyperlipidemia patients(triglyceride(TG)2.3-6.5 mmol·L-1)were randomly received placebo(po,n = 81),CoA 200 U·d-1(po,n = 84)or CoA 400 U·d-1 group(po,n = 79)for 8 weeks.Blood routine,urine routine,hepatic function,renal function,blood glucose and blood lipid were measured at 4 weeks and 8 weeks.The primary end point was the percentage change in TG from baseline to week 4 and week 8.Variation rates of plasma total cholesterol(TC),low-density lipoprotein cholesterol(LDL-C)and high-density lipoprotein cholesterol(HDL-C)were the secondary end points.Adverse events were compared after the treatment.RESULTS After the treatment for 4 weeks,TG levels of the placebo group,the CoA 200 U·d-1group and the CoA 400 U·d-1group were reduced 5.1%,15.7% and 14.4% respectively,and 0.9%,21.7% and 36.1% after 8 weeks treatment.Compared with the placebo group and the baseline level,TG levels in the CoA 200 U·d-1 group and the CoA 400 U·d-1 group significantly decreased(P < 0.01),and there was significant difference between the CoA 200 U·d-1 group and 400 U·d-1 group(P < 0.01).There were no significant differences of TC,LDL-C and HDL-C(P > 0.05)and drug-related adverse event rates(P = 0.11)among the three groups after the treatment.CONCLUSION It was shown that CoA reduced serum TG level effectively and with good safety and tolerance in the hyperlipidemia patients.