ESH Excellence Hypertension Centre, Internal Medicine Unit, Santa Maria della Misericordia General Hospital, AULSS 5 Polesana, Rovigo, Italy.
Food Funct. 2018 Jul 17;9(7):3845-3852. doi: 10.1039/c8fo00415c.
Background - The clinical hypocholesterolemic effect of nutraceutical compounds (NCs) containing red yeast rice extracts providing a daily dose of 2.5-10 mg of monacolin K is now well established. For this reason, NCs may be a viable alternative to the statin drugs commonly used to lower cholesterol levels. However, in order to avoid some possible statin-like side effects, most NCs available on the market contain low doses of monacolin K, which could reduce their efficacy. The aim of this study was to investigate the efficacy and safety of a NC containing high doses of monacolin K (10 mg) in improving the lipid profile and glucose metabolism when added to the diet versus the diet alone in a group of hypertensive and hyper-cholesterolemic subjects at low cardiovascular risk. Methods - Thirty subjects with grade-1 essential hypertension (mean age 51.5 ± 7.8 years, 62.9% males) were enrolled in the treatment group (NC group). These subjects followed a programmed diet and took one tablet a day of a NC containing red yeast rice, policosanols, resveratrol and chromium picolinate for 1 month and were compared with an equivalent group of subjects that followed only a diet program. Differences in serum total cholesterol (TC), low-density- and high-density-lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG) and blood glucose between groups were compared by analysis of variance. Results - In both groups, a significant reduction of TC, TG and LDLC was observed. In the treatment group from the baseline to the follow-up the reduction of TC (230.93 ± 28.0 vs. 188.63 ± 18.1, p < 0.001) and LDLC (153.10 ± 22.5 vs. 116.54 ± 17.7, p < 0.001) was significantly greater compared to the control group (differences between treatments = 9.19% and 12.29%, respectively); in addition a significant higher reduction in blood glucose (89.1 ± 7.6 vs. 83.7 ± 4.6, p < 0.001) was also observed (differences between treatments = 4.28%). HDLC levels remained unchanged in both groups. Conclusions - In summary, the NC containing high doses of monacolin K appeared to be safe, well tolerated and effective at improving lipid and glucose patterns.
背景 - 含有红曲米提取物的营养化合物 (NCs) 可降低胆固醇，每日剂量为 2.5-10 毫克的洛伐他汀已得到充分证实。因此，NCs 可能是降低胆固醇水平的常用他汀类药物的一种可行替代品。然而，为了避免一些可能的他汀类药物副作用，市场上大多数 NCs 含有低剂量的洛伐他汀，这可能会降低其疗效。本研究旨在探讨含有高剂量洛伐他汀 (10 毫克) 的 NC 在改善血脂谱和葡萄糖代谢方面的疗效和安全性，同时将其添加到饮食中与单独饮食相比，在一组低心血管风险的高血压和高胆固醇血症患者中的作用。方法 - 30 名 1 级原发性高血压患者（平均年龄 51.5 ± 7.8 岁，62.9%为男性）入组治疗组（NC 组）。这些患者遵循程序化饮食，并每天服用一片含有红曲米、植物固醇、白藜芦醇和吡啶甲酸铬的 NC，持续 1 个月，并与仅遵循饮食方案的等效组患者进行比较。通过方差分析比较两组之间血清总胆固醇 (TC)、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇 (LDLC 和 HDLC)、甘油三酯 (TG) 和血糖的差异。结果 - 两组患者 TC、TG 和 LDLC 均显著降低。在治疗组，从基线到随访时 TC（230.93 ± 28.0 与 188.63 ± 18.1，p < 0.001）和 LDLC（153.10 ± 22.5 与 116.54 ± 17.7，p < 0.001）的降低幅度明显大于对照组（治疗差异分别为 9.19%和 12.29%）；此外，血糖也显著降低（89.1 ± 7.6 与 83.7 ± 4.6，p < 0.001）（治疗差异为 4.28%）。两组 HDLC 水平均无变化。结论 - 总之，含有高剂量洛伐他汀的 NC 似乎安全、耐受良好且有效，可改善血脂和血糖模式。
