Department of Medical, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China.
Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
J Tradit Chin Med. 2022 Apr;42(2):264-271. doi: 10.19852/j.cnki.jtcm.2022.02.007.
To assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K β-hydroxy acid form (MKA), Heye (), and Cangzhu (), compared to lifestyle modifications.
Totally 117 subjects with moderate to severe dyslipidemia (according to Chinese guidelines) and low CV risk were randomly assigned into three treatment groups: lifestyle modification (LM), LM plus a low dosage of MKA, LM plus a high dosage of MKA, and treated for 60 d. The primary endpoint was the reduction of low density lipoprotein cholesterol (LDL-C) and total cholesterol (TC). Safeties along with Traditional Chinese Medicine Syndromes were assessed through the study.
A low dosage of MKA along with lifestyle modifications caused a significant decrease in LDL-C by 15.6% on average (95% , 9.6% to 21%) with, a decrease in TC by 15.3% on average (95% CI, 9.26% to 21.4%), and a decrease in non-HDL-C by 35.4% (95% CI, 25.76% to 41.34%). Weak evidence of a reduction of triglycerides but an increment of HDL-C was observed in patients with severe hyperlipidemia. No severe adverse events occurred during the study.
Our results confirm the LDL-C and TC lowering properties of MKA is clinically meaningful. It also produces a significant reduction of non-HDL-C, and slightly effects on TG and HDL-C as well.
评估含有洛伐他汀β-羟基酸形式（MKA）、荷叶（Heye）和苍术（Cangzhu）的膳食补充剂在降低血脂方面的活性和安全性，与生活方式改变相比。
共有 117 名血脂中度至重度异常（根据中国指南）且心血管风险低的受试者被随机分为三组：生活方式改变组（LM）、LM 加低剂量 MKA、LM 加高剂量 MKA，并治疗 60 天。主要终点是降低低密度脂蛋白胆固醇（LDL-C）和总胆固醇（TC）。通过研究评估安全性和中药证候。
低剂量 MKA 与生活方式改变相结合，平均降低 LDL-C15.6%（95%置信区间，9.6%至 21%），降低 TC15.3%（95%置信区间，9.26%至 21.4%），降低非高密度脂蛋白胆固醇 35.4%（95%置信区间，25.76%至 41.34%）。在严重高脂血症患者中，观察到甘油三酯略有降低但高密度脂蛋白胆固醇略有升高的弱证据。在研究过程中未发生严重不良事件。
我们的结果证实了 MKA 降低 LDL-C 和 TC 的作用具有临床意义。它还能显著降低非高密度脂蛋白胆固醇，对 TG 和 HDL-C 也有一定影响。
