多廿烷醇与普伐他汀治疗高脂血症的疗效和安全性

目的评价多廿烷醇治疗高脂血症,特别是高胆固醇血症的疗效和安全性。方法多甘烷醇组(试验组,多廿烷醇10mg·d~(-1))和普伐他汀组(对照组,普伐他汀10 mg·d~(-1))各119例。进行随机、双盲、双模拟、阳性药物平行对照试验。观察2组降脂疗效和不良反应发生情况。结果经过12 wk治疗,多廿烷醇组总胆固醇(TC)、低密度脂蛋白胆固醇(LDL)、TC-高密度脂蛋白胆固醇(HDL-C)/ HDL-C、载脂蛋白B_(100)(Apo B_(100))、脂蛋白(Lpa)治疗前分别为(6.6±s0.7)、(4.0±0.6)、(0.10±0.03)、(3.3±0.5)mmol·L~(-1)、(260±184)mg·L~(-1),治疗后分别为(6.0±1.3)、(3.5±0.8)、(O.09±0.04)、(2.7±0.8)mmol·L~(-1)、(130±130)mg·L~(-1),治疗后各指标较治疗前均有非常显著差异(P<0.01)。普伐他汀组TC、LDL-C、TC-HDL-C/HDL-C、Apo B_(100)、Lpa治疗前分别为(6.7±0.8)、(4.1±0.7)、(0.10±0.03)、(3.4±0.5)mmol·L~(-1)、(279±240)mg·L~(-1),治疗后分别为(6.0±1.3)、(3.5±0.9)、(0.09±0.03)、(2.8±0.8)mmol·L~(-1)、(182±213)mg·L~(-1),治疗后各指标较治疗前均有非常显著差异(P<0.01)。但2组相比较,调脂作用相似,无显著差异(P>0.05)。不良反应方面,多廿烷醇组(9.2%)明显少于普伐他汀组(18.5%),2组有显著差异(P<0.05)。不良反应大多较轻微,不需停药能自行缓解。结论多廿烷醇10 mg·d~(-1)降脂效果与普伐他汀10 mg·d~(-1)的疗效相当,均能明显降低TC、LDL-C、TC-HDL-C/ HDL-C、Apo B_(100)、Lpa。多廿烷醇的安全性优于普伐他汀,不良反应轻微,耐受性好。

Efficacy and safety of policosanol and pravastatin in treatment of hyperlipidemia in Chinese patients

AIM To evaluate the efficacy and safety of policosanol manufactured by Laboratorios Dalmer S.A of Cuba in the treatment of hyperlipidemia,especially hypercholesterolemia.METHODS This study was conducted as a randomized,double-blinded,double-dummy and parallel controlled trial.Patients with hyperlipi- demia were randomized into the trial group and the control group.Policosanol 10 mg.d~(-1) was administered to 1 19 patients in trial group and pravastatin 10 mg·d~(-1) was given to 119 patients in control group.The efficacy and adverse reactions were observed.RESULTS TC,LDL-C,TC-HDL-C/HDL-C,Apo B_(100,Lpa in trial group were (6.0±s 1.3),(3.5±0.8),(0.09±0.04),(2.7±0.8) mmol·L~(-1),(130±130) mg·L~(-1) after the treatment and(6.6±0.7),(4.0±0.6),(0.10±0.03),(3.3±0.5) mmol·L~(-1),(260±184)mg·L~(-1) before the treatment.Those in control group were(6.0±1.3),(3.5±0.9),(0.09±0.03),(2.8±0.8) mmol·L~(-1),(182±213)mg·L~(-1) after the treatment and(6.7±0.8),(4.1±0.7),(0.10±0.03),(3.4±0.5)mmol·L~(-1),(279±240)mg·L~(-1) before the treatment.The improvement in two groups was significant(P<0.01).The policosanol was similar to pravastatin in decreasing lipidemia.There was no significant difference between two groups(P>0.05).Adverse reactions(ADR)in trial group(9.2 %)were significantly lower than that in control group (18.5 %).Most of the ADR were mild and can be remitted.CONCLUSION Policosanol 10 mg·d~(-1) can significantly decrease TC,LDL-C,TC-HDL-C/HDL-C,Apo B_(100) and Lpa.The policosanol is superior to pravastatin in ADR.The ADR caused by policosanol are mild and can be well tolerated.