辅酶A对高脂血症患者的疗效及安全性  

Effect and safety of coenzyme A on hyperlipidemia

作　　者：赵水平[1] 陈雅琴[1] 陈君柱[2] 来江涛[2] 

机构地区：[1]中南大学湘雅二医院心内科,湖南长沙410011 [2]浙江大学医学院附属第一医院心内科,浙江杭州310003

出　　处：《中国新药与临床杂志》2012年第5期242-246,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：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。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 II clinical 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-lgroup and the CoA 400 U＇d-lgroup 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·L-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·L-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.

关 键 词：乙酰辅酶A 血脂异常 三酰甘油类 高三酰甘油血症 药物不良反应 

分 类 号：R541.4[医药卫生—心血管疾病]