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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。
Objective To study the efficacy and safety of oral coenzyme A in patients with hyperlipidemia. Methods This randomized, double-blind, parallel, placebo-controlled, multicentre phase II trial of 244 patients with hyperlipidemia with triglycerides (TG) of 2.3 to 6.5 mmol.L-1 was randomized to placebo (N = 81), coenzyme A 200 Ud-1 (n = 79) and coenzyme A 400 Ud-1 (n = 84). The patients were treated with placebo and corresponding coenzyme A daily for 8 weeks. Respectively, wk 0,4,8 determination of blood, lipid parameters, urine, liver function, renal function and blood glucose. The main endpoint efficacy index for the change of TG before and after treatment, the secondary efficacy indicators of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) rate of change. And examine the safety of coenzyme A. Results TG decreased by 5.1%, 15.7% and 14.4% in the placebo group, coenzyme A 200 Ud-1 group and the 400 Ud-1 group after 4 weeks of treatment. After 8 weeks of treatment, the TGs in the 3 groups decreased by 0.9% and 21.7% 36.1%. Coenzyme A 200 Ud-1 group and 400 Ud-1 group compared with before treatment and placebo group, TG were significantly lower (P <0.01); Coenzyme A 400 Ud-1 group TG amplitude was significantly greater than coenzyme A 200 Ud -1 group (P <0.01). There were no significant differences in TC, LDL-C and HDL-C between the three groups before and after treatment (all P> 0.05). There was no significant difference in the incidence of adverse reactions between the three groups (P = 0.11). Conclusion Coenzyme A can effectively reduce the level of TG in patients with hyperlipidemia, with good safety.