生活方式控制联合纳豆红曲胶囊降低血脂的临床研究  

Clinical Study on Lowering Blood Lipid Level by Lifestyle Control Combined with Nattokinase(NK)-Red Yeast Rice(RYR)Capsules

作　　者：于逢春 周洋 张新宇 范承哲[4] 李会军 宋哲[4] 陈志刚[3] 毕齐 YU Feng-chun;ZHOU Yang;ZHANG Xin-yu;FAN Cheng-zhe;LI Hui-jun;SONG Zhe;CHEN Zhi-gang;BI Qi(Beijing Neurology Society,Beijing 100081,China;Department of internal medicine,Beijing Beiya Hospital of Traditional Chinese Medicine,Beijing 100029,China;Department of encephalopathy,Dongfang Hospital Beijing University of Chinese Medicine,Beijing 100078,China;Department of neurology,Beijing Anzhen Hospital Capital Medical University,Beijing 100029,China;Department of neurology,Beijing Beiya Orthopedic Hospital,Beijing 102445,China)

机构地区：[1]北京神经内科学会,北京100081 [2]北京北亚中医医院内科,北京100029 [3]北京中医药大学附属东方医院脑病科,北京100078 [4]首都医科大学附属北京安贞医院神经内科,北京100029 [5]北京北亚骨科医院神经内科,北京102445

出　　处：《中华养生保健》2024年第4期15-17,21,共4页CHINESE HEALTH CARE

摘　　要：目的研究生活方式控制联合纳豆红曲胶囊降低血脂的有效性及安全性。方法根据纳入及排除标准募集高脂血症志愿者,按照2:1的比例随机分为纳豆红曲组(生活方式控制+纳豆红曲胶囊)20例和生活方式控制组(单纯生活方式控制)10例。两组试验期间均进行生活方式控制,纳豆红曲组同时服用崇健纳豆红曲胶囊1.35 g bid,共90 d;入组后第0天、30天、60天及90天对所有受试者进行访视,记录0 d及90 d的血脂四项、肝肾功能及各访视点的不良事件发生情况;比较分析两组试验前后血脂四项、肝肾功能变化及不良事件发生情况等。结果纳豆红曲组试验前后比较,低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)明显下降(P<0.05);总胆固醇(total cholesterol,TC)有明显下降(P<0.05);生活方式控制组试验前后LDL-C及TC水平比较,差异无统计学意义(P>0.05);两组高密度脂蛋白胆固醇(High density lipoprotein cholesterol,HDL-C)各自试验前后比较,差异无统计学意义(P>0.05);两组甘油三酯(triglyceride,TG)、谷丙转氨酶(alanine transaminase,ALT)、谷草转氨酶(aspartate aminotransferase,AST)、血肌酐(creatinine,Cr)各自试验前后比较,差异无统计学意义(P>0.05),两组受试者试验期间均未发生不良事件。结论与单纯生活方式控制相比,对高脂血症患者予生活方式控制联合纳豆红曲胶囊干预可以有效降低LDL-C及TC水平。Objective To study the efficacy and safety of lifestyle control combined with Nattokinase Red yeast rice(NK-RYR)capsules in reducing blood lipids.Methods Hyperlipidemia volunteers were recruited according to inclusion and exclusion criteria,and randomly divided into NK-RYR capsules group(lifestyle control+NK-RYR capsules)with 20 cases and lifestyle control group(lifestyle control alone)with 10 cases according to the ratio of 2:1.Lifestyle control was carried out in both groups during the experiment.The NK-RYR capsules group received Chongjian NK-RYR capsules(1.35g bid)at the same time,for a total of 90 days.All subjects were interviewed on 0 d,30 d,60 d and 90 d after enrollment,and the four items of blood lipids,liver and kidney function and adverse events at each site were recorded on 0d and 90d.Four items of blood lipids,changes of liver and kidney function and adverse events before and after the two groups were compared.Results Low density lipoprotein cholesterol(LDL-C)was significantly decreased in the NK-RYR capsules group before and after the test(P<0.05).total cholesterol(TC)decreased significantly(P<0.05);There was no significant difference in LDL-C and TC levels in lifestyle control group(P>0.05).There was no significant difference in High density lipoprotein cholesterol(HDL-C)between the two groups before and after each test(P>0.05).There was no significant difference in triglyceride(TG),alanine aminotransferase(ALT),aspartate aminotransferase(AST),and serum creatinine before and after the trial between the two groups(P>0.05),and no adverse events occurred during the trial between the two groups.Conclusion Compared with lifestyle control alone,the combination of lifestyle control and NK-RYR capsules can reduce LDL-C and TC levels in hyperlipidemia patients.

关 键 词：纳豆红曲胶囊 生活方式控制 低密度脂蛋白胆固醇 总胆固醇 

分 类 号：R741[医药卫生—神经病学与精神病学]