Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet.
Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet.
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DOI：
10.1007/s12349-010-0043-6
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发表时间：
2011-08
影响因子：
1.1
通讯作者：
Crispo, Salvatore
中科院分区：
文献类型：
--
作者：
Trimarco, Bruno;Benvenuti, Claudio;Rozza, Francesco;Cimmino, Claudia Sara;Giudice, Renata;Crispo, Salvatore
一项针对血脂异常患者的大型研究在临床实践中测试了含有天然降血脂药物（如红曲、普利醇和小檗碱）的新型专利专有天然营养药物 (PN) 组合的功效。设计了一项平行、对照、随机、多中心研究。采用稳定饮食方案 2 周后，患者被随机分配到 PN 1 片/天并结合饮食 (PN + D) 或单独饮食 (D)，持续 16 周。入选标准为：总胆固醇 >200 mg/dL 或 LDL-Chol >150 mg/dL，且没有明确的他汀类药物适应症，或血浆甘油三酯 >150 mg/dL。在基线和每月评估血脂模式和CV参数。 248 个意大利单位入组了 1,751 名患者，其中 933 名患者接受 PN + D，818 名患者接受 D。基线血脂值为：Tot-Chol 255.4 vs 243.1 mg/dL、LDL-Chol 170.1 vs 162.2 mg/dL、HDL-Chol 50.0 vs 48.8 mg/dL 和 TG 190.5 与 184.4 毫克/分升。与 D 组相比，PN 持续显着改善血脂参数：第 16 周时，Tot-Chol 为 -19.1% 对比 -9.4%（p < 0.001），LDL-Chol 为 -23.5% 对比 -10.8%（p < 0.001），HDL-Chol +11.6 对比 +4.0%（p < 0.001），-17.9% 对比TG 为 −11.3%（p < 0.001）。总之，PN 加饮食可以有效改善血脂，显着降低整体心血管风险，表明 PN 在预防 CHD 中发挥作用。
Efficacy of a new patented proprietary combination of natural nutraceuticals (PN) containing natural hypolipidemic as red yeast, policosanol and berberine was tested in a large study on dyslipidemic patients in clinical practice. A parallel, controlled, randomized, multicenter study was designed. After 2 weeks on a stable dietary regimen, the patients were randomized to PN 1 tablet/day associated with diet (PN + D) or diet alone (D) for 16 weeks. Entry criteria were: Tot-Chol >200 mg/dL or LDL-Chol >150 mg/dL without a clear indication for statins, or plasma triglycerides >150 mg/dL. Lipid pattern and CV parameters were evaluated at baseline and monthly. 1,751 patients were enrolled in 248 Italian units, 933 patients on PN + D and 818 on D. The baseline lipid values were: Tot-Chol 255.4 versus 243.1 mg/dL, LDL-Chol 170.1 versus 162.2 mg/dL, HDL-Chol 50.0 versus 48.8 mg/dL, and TG 190.5 versus 184.4 mg/dL. PN constantly and significantly improved lipid parameters versus D group: at 16 weeks −19.1 versus −9.4% for Tot-Chol (p < 0.001), −23.5 versus −10.8% for LDL-Chol (p < 0.001), +11.6 versus +4.0% for HDL-Chol (p < 0.001), −17.9 versus −11.3% for TG (p < 0.001). In conclusions, PN plus diet allows an effective improvement of blood lipids with a significant reduction of global CV risk, suggesting a role for PN in CHD prevention.