part 1.
本研究使用具抑制肝臟合成膽固醇(cholesterol)作用的紅麴與乳酸菌桿菌屬中的Lactobacillus casei經由胃腸道作用抑制膽固醇吸收，兩者合併使用，觀察同時抑制肝臟合成膽固醇的合成與經由胃腸道作用降低膽固醇的機制是否具有加乘作用。
納入條件：(1)18歲以上之成年人(2)低密度脂蛋白（low density lipoprotein cholesterol, LDL-C）大於160mg/dl或三酸甘油脂(triglyceride, TG)大於200mg/dl。符合收案條件之60位受試者於簽署同意書後，隨機分派為治療組(紅麴加Lactobacillus casei)30位與控制組(紅麴加安慰劑) 30位，治療期8週，延伸追蹤期4週受試者於第0、4、8、12週回診接受抽血檢測LDL-C、高密度脂蛋白（high density lipoprotein cholesterol, HDL-C）、血中總膽固醇值(total cholesterol)、TG、血糖（blood glucose）、尿酸（uric acid）、高敏感性C反應蛋白（hs-CRP）。
受試者第0週之基本資料，未達到統計上之顯著差異。第八週時兩組之LDL-C均較第0週為低，治療組降低33.85
part 1.
To compare the cholesterol-lowering effect of red yeast rice plus probiotic（Lactobacillus casei）and red yeast rice plus placebo.
The study was a 12-weeks’ double-blinded placebo-controlled study. After at least 4-week washout /diet control period, sixty patients with primary dyslipidemia defined by low density lipoprotein cholesterol (LDL-C) more than 160 mg/dl or triglyceride more than 200 were randomized to a 8-week treatment of red yeast rice plus probiotic or red yeast rice plus placebo, then shifted to the second 4-week washout /diet control period. Lipid parameters and safety assessments were done at week 0, 4 and 8. The primary endpoint was the mean percent change of LDL-C from baseline to week 8. The secondary endpoints were the mean percent changes from baseline in total cholesterol, triglycerides and safety issues.
We had enrolled and randomized 60 subjects. The baseline characteristics were comparable between two groups. At week 8, both groups achieved significant reduction of serum LDL
(33.9 26.7 vs 38.1
