红曲对中度血脂升高美国人调节血脂作用的临床研究

Clinical study on cholesterol- lowering effect of RYR Cholestin among Americans with moderate hypercholesterolemia

[目的]评价在饮食控制的情况下红曲（RYRCholestin）对美国高血脂人群的降脂作用和安全性。[方法]开放标记，自身对照，多中心临床试验。187名美国高血脂人群入选（血清低密度脂蛋白胆固醇3．50—4．92mmol／L，总胆固醇5．18—7．25mmol／L；男116人，女71人），162入完成试验。在整个试验中受试者遵照美国国家胆固醇教育计划的饮食要求。试验的前4周仅控制饮食，第5周至第12周连续服用8周RYRCholestin（每日2．4g）。[结果]经前4周饮食控制，血清脂质各指标无显著变化。口服RYRCholestin8周后，血清总胆固醇、低密度脂蛋白胆固醇和三酰甘油分别降低16．6％，24．O％和25．2％，高密度脂蛋白胆固醇升高14．3％（P〈0．001）。显效率为79．0％，有效率为97．5％。停服14d（2周）后，血脂各指标回到试验前水平。试验中共发现可能与服用产品相关的、轻度的29项不良反应。[结论]RYRCholestin的耐受性良好，它可降低血清总胆固醇、低密度脂蛋白胆固醇和三酰甘油，升高血清高密度脂蛋白胆固醇。停服2用后受试者的血脂各项指标均恢复到试验前水平。

[ Objective ] To evaluate lipid -lowering efficacy and safety of RYR Cholestin, or Monascus purpureus （Red Yeast） Rice, in Americans with moderate hypercholesterolemia. [ Methods] This study was an open-label, self-control, and multi -center clinical trial. A total of 187 subjects were entered into this trial （serum LDL-Cholesterol 3.50 ～ 4.92 mmol/L, total cholesterol 5.18 ～ 7.25 retool/L, male ：female = 116：71 ） , of whom 162 completed the study. Subjects were placed on the NCEP Step I Diet throughout the study and RYR Cholestin （2.4 g/day） was administered for 8 weeks following initial 4 - week diet control. [ Results] Being on the diet alone for 4 weeks resulted in no significant changes in serum lipids. RYR Cholestin treatment for 8 weeks reduced serum total cholesterol, LDL-Cholesterol and triglycerides by 16.6% , 24.0% , and 25.2%, respectively, and increased HDL-Cholesterol by 14.3% （ all P 〈0.001 ）. There were 97.5% of patients having≥ 10% improvement in at least one of lipid risk factors, and 79.0% having ≥20% improvement. Discontinuation of RYR Cholestin intervention for 14 d led to a return of serum lipids to baseline of pre - study. And 29 possible product - related mild adverse re- actions were reported. [ Conclusion ] RYR Cholestin is well tolerated and effective in reducing total and LDL-Cholesterol, and triglycerides, as well as in increasing HDL-Cholesterol in hypercholesterolemic patients, but those indicators return to the beginning baseline when the treatment is discontinued.