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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。
Objective To compare the efficacy of oral coenzyme A and pantethine in patients with hyperlipidemia. Methods This randomized, double-blind, parallel-controlled, multi-center phase III trial of 223 patients with hyperlipidemia of triglyceride (TG) 2.3-6.5 mmol·L -1 was randomly divided into coenzyme A (N = 114) and pantethine (n = 109). Coenzyme A 400 U and pantethine 600 mg were orally administered daily for 8 weeks. Blood was collected at 0, 4, and 8 weeks respectively for determination of blood routine, lipid parameters, urine routine, liver function, renal function, creatine kinase and blood glucose. The primary outcome measure was the rate of change of TG, the change of total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) before and after treatment. And examine the safety of coenzyme A and pantethine. Results After 4 weeks of treatment, TG decreased by 26.0% and 17.4% in coenzyme A group and pantethine group, respectively. After 8 weeks of treatment, the TG decreased by 33.3% and 16.5% respectively, with significant difference between the two groups (P <0.01). There was a significant difference (P <0.05) between TC reduction rate in coenzyme A group and pantethine group after 8 weeks of treatment, there was no significant difference in LDL-C, HDL-C and incidence of adverse reactions between the two groups (P> 0.05 ). Conclusions Both pantethine and coenzyme A can lower TG, coenzyme A is superior to pantethine, and has good safety.