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題名 | 紅麴加上益生菌對降血脂作用之評估=The Cholesterol-Lowering Effect of LipoCol Forte Combined Lactobacillus Casei |
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作 者 | 李建瑩; 魏正宗; | 書刊名 | 中醫藥年報 |
卷期 | 光碟版1:3 2012.10[民101.10] |
頁次 | 頁109-129 |
專輯 | 中藥機轉及療效 |
分類號 | 413.4 |
關鍵詞 | 紅麴; 益生菌; 降血脂; Red yeast rice; Probiotic; Hyperlipidemia; |
語文 | 中文(Chinese) |
中文摘要 | 研究目的: 本研究將使用抑制肝臟合成膽固醇(cholesterol)的紅麴與乳酸菌桿菌屬中的 Lactobacillus casei經由胃腸道作用,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與協同效果。 研究方法: 收集原發性高血脂症患者共 60位。納入條件:(1)18歲以上之成年人(2)病人低密度脂蛋白(LDL)大於 160mg/dl或三酸甘油脂(TG)>200mg/dl。排除條件:(1)懷孕或正授乳的婦女(2)進入篩選期前需 Washout 30 day:如 HMG-CoA還原酵素抑制劑(HMG-CoA reductase inhibitor)、膽酸結合劑(bile acid binding resins)、菸鹼酸 (nicotinic acid或 niacin)、Fibrate類衍生物(fibrate derivatives)或膽固醇吸收抑制劑(cholesterol absorption inhibitor)(3)進入篩選期前 30天內有改變西藥降血糖之用藥:如有服用 α-glucosidase inhibitor、 Sulfonylurea、 Biguanide、Meglitinide或 PPAR agonists(4)進入篩選期前 30天內有服用其他保健食品(5)生化值異常:血清肌肝酸≥ 3.0 mg/dl;GPT超過正常數值 5倍。符合收案條件之受試者於簽署同意書後,隨機分派為治療組(壽美降脂一號加Lactobacillus casei)或對照組壽美降脂一號加安慰劑,治療期 8週,延伸追蹤期 4週受試者於第 0、4、8、12週回診接受低密度脂蛋白(LDL-cholesterol)、高密度脂蛋白(HDL-cholesterol)、血中總膽固醇值(total cholesterol)、三酸甘油脂(TG)、血糖(glucose)、尿酸(uric acid)、高敏感性 C反應蛋白(Hs-CRP)。 結果與討論: 共 60位受試者被納入於研究,並隨機分派於治療組(n=30)與控制組(n=30)。受試者第 0週之人口學基本特徵,未達到統計上之顯著差異。第八週時兩組之低密度脂蛋白均較第 0週降低,治療組降低 33.9±26.7 mg/dl,控制組降低 38.1±30.6 mg/dl,但兩組之間未達統計上差異(p=0.58)。兩組之總膽固醇均較第 0週降低,但兩組之間未達統計上差異。(-46.6 ±31.1 vs -44.5± 27.5 mg/dl, p=0.79)兩組之指標達統計上顯著差異者為第十二週治療組平均舒張壓降低 2.7、安慰劑組平均舒張壓增加 4.4 mmHg (p=0.021)。 結論: 紅麴膠囊壽美降脂一號可有效降低總膽固醇及低密度脂蛋白。但加上益生菌 Lactobacillus casei並無加乘作用。 |
英文摘要 | Aim: To compare the cholesterol-lowering effect of red yeast rice (LipoCol Forte) plus probiotic (Lactobacillus casei) and red yeast rice (LipoCol Forte) plus placebo. Method: 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 LDL 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-cholesterol from baseline to week 8. The secondary endpoints were the mean percent changes from baseline in total cholesterol, triglycerides and safety issues. In year 2, we’ll investigate the pathogenesis of red yeast rice plus probiotic by testing biomarkers including fibrinogen, platelet aggregation function, hs-CRP, cytokines, homocysteine. Results & Discussion: The is a 2-years study. At the end of year 1 (Nov., 2009), 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±30.6 mg/dl, p=0.58 )and total cholesterol (46.6 ±31.1 vs -44.5± 27.5 mg/dl, p=0.79) compared to baseline. There were no statistical significance between two groups regarding reduction of LDL and total cholesterol. Conclusions: Red yeast rice capsule (ipoCol Forte) can reduce LDL and total cholesterol in patients with hyperlipidemia. But the add-on of probiotic (Lactobacillus casei) had no additional effect. |
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