CAJ | 학술논문

[目的]评价在饮食控制的情况下红曲（ RYR Cholestin ）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3．50～4．92 mmol/L，总胆固醇5．18～7．25 mmol/L；男116人，女71人），162人完成试验。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RYR Cholestin（每日2．4 g）。[结果]经前4周饮食控制，血清脂质各指标无显著变化。口服RYR Cholestin 8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％，24．0％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14 d（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] RYR Cholestin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周后受试者的血脂各项指标均恢复到试验前水平。
[목적]평개재음식공제적정황하홍곡（ RYR Cholestin ）대미국고혈지인군적강지작용화안전성。[방법]개방표기，자신대조，다중심림상시험。187명미국고혈지인군입선（혈청저밀도지단백담고순3．50～4．92 mmol/L，총담고순5．18～7．25 mmol/L；남116인，녀71인），162인완성시험。재정개시험중수시자준조미국국가담고순교육계화적음식요구。시험적전4주부공제음식，제5주지제12주련속복용8주RYR Cholestin（매일2．4 g）。[결과]경전4주음식공제，혈청지질각지표무현저변화。구복RYR Cholestin 8주후，혈청총담고순、저밀도지단백담고순화삼선감유분별강저16．6％，24．0％화25．2％，고밀도지단백담고순승고14．3％（P＜0．001）。현효솔위79．0％，유효솔위97．5％。정복14 d（2주）후，혈지각지표회도시험전수평。시험중공발현가능여복용산품상관적、경도적29항불량반응。[결론] RYR Cholestin적내수성량호，타가강저혈청총담고순、저밀도지단백담고순화삼선감유，승고혈청고밀도지단백담고순。정복2주후수시자적혈지각항지표균회복도시험전수평。
[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 mmol/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 .