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Abstract：
Dietary supplementation with sugar cane derivates may modulate low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin/kexin type 9 (PCSK9) levels. The purpose of this study was to determine if dietary supplement (DS), containing Octacosanol (20 mg) and vitamin K2 (45 µg), could restore the disrupted physiologic relation between LDL-C and serum PCSK9. Double-blind, randomized, placebo-controlled, single-center study including 87 patients on chronic atorvastatin therapy was conducted. Eighty-seven patients were randomized to receive DS (n = 42) or placebo (n = 45), and followed for 13 weeks. Serum PCSK9 levels, lipid parameters and their relationship were the main efficacy endpoints. The absolute levels of PCSK9 and LDL-C were not significantly different from baseline to 13 weeks. However, physiologic correlation between % change of PCSK9 and % change of LDL-C levels was normalized only in the group of patients treated with DS (r = 0.409, p = 0.012). This study shows that DS can restore statin disrupted physiologic positive correlation between PCSK9 and LDL-C. Elevated PCSK9 level is an independent risk factor so controlling its rise by statins may be important in prevention of cardiovascular events.
摘要：
甘蔗衍生物的饮食补充可以调节低密度脂蛋白胆固醇（LDL-C）和前蛋白转化酶枯草杆菌蛋白酶/kexin9型（PCSK9）水平。这项研究的目的是确定膳食补充剂（DS），含有二十八烷醇（20毫克）和维生素K2（45微克），可以恢复LDL-C与血清PCSK9之间的生理关系。双盲,随机化，安慰剂对照,纳入87例慢性阿托伐他汀治疗患者的单中心研究.87例患者随机接受DS（n=42）或安慰剂（n=45），并随访了13周。血清PCSK9水平，血脂参数及其关系是主要疗效终点.PCSK9和LDL-C的绝对水平从基线到13周没有显着差异。然而,PCSK9的%变化和LDL-C水平的%变化之间的生理相关性仅在接受DS治疗的患者组中正常化(r=0.409,p=0.012).这项研究表明，DS可以恢复他汀类药物破坏的PCSK9和LDL-C之间的生理正相关。PCSK9水平升高是一个独立的危险因素，因此通过他汀类药物控制其升高可能对预防心血管事件很重要。
