查詢結果分析
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頁籤選單縮合
題 名 | Efficacy and Safety of Fluvastatin in Patients with Non-Insulin-Dependent Diabetes Mellitus and Hypercholesterolemia=以Fluvastatin與Placebo比較治療非胰島素依賴型糖尿病合併高膽固醇血症患者之臨床療效及安全性評估 |
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作 者 | 丁予安; 許惠恆; 扈春安; 裴馰; | 書刊名 | Acta Cardiologica Sinica |
卷 期 | 13:3 民86.07-09 |
頁 次 | 頁138-144 |
分類號 | 418.271 |
關鍵詞 | 非胰島素依賴型糖尿病; 高膽固醇血症; NIDDM; Hypercholesterolemia; Fluvastatin; |
語 文 | 英文(English) |
中文摘要 | 背景:近年來從多項流行病學及動實驗的研究,證明血中膽固醇濃度與心臟冠狀動脈疾病有密不可分的關係。由於血液凝固及纖維溶解功能改變,血栓栓塞症也是常見的併發症之一。糖尿病患者合併高膽固醇血症,其罹患冠狀動脈疾病為糖尿病無血脂異常患者2至3倍的罹病率。本研究是為了評估一種HMG-CoA reductase inhibitor (Fluvastatin)對治療糖尿病合併膽固醇血症的療效。 方法:共有40名患者完成了此項隨機雙盲性試驗。經過六週的標準飲食控制,糖尿病患者血中低密度脂蛋白仍超過135mg/dl且無其他器官疾病的患者,被隨機分為每天服用Fluvastatin 20mg組(n=20)及服用安慰劑(n=20)。經六週治療後,二組的藥物劑量加倍(40mg)再治療六週。 結果:在服用二種不同劑量的Fluvastatin組,血中總膽固醇,低密度脂蛋白及低密度脂蛋白╱高密度脂蛋白膽固醇比值(4.1 ± 0.3 vs 2.5 ± 0.2 vs 2.5 ± 0.2, P < 0.01)有明顯改善,但對血中高密脂蛋白及三酸甘油則無影饗。在服用安慰劑組,血中膽固醇、低密度脂蛋白、高密度脂蛋白、低密度脂蛋白/高密度脂蛋白膽固醇比值及三酸甘油脂方面均無變化。無論在服用安慰劑組或Fluvastatin治療組,對空腹血糖化蛋白(fructosamine)均無影饗。在血小板功能評估方面,我們是以β-TG及PF-4作為體內血小板活化指標,在安慰劑及Fluvastatin治療組,並未發現改變。另外血中肝功能及肌肉病變的生化指標,在實驗中均維持正常。在整個試驗中,患者並無副作用發生。 結論:綜言之,Fluvastatin無論以每天20mg或40mg服用,均可有效治療非胰島素依賴型糖尿病合併高膽固醇血症的患者,對血液凝固及纖維溶解系統並無改變,且無任何併發症發生。由此臨床治療試驗證實Fluvastatin的確為一有效且安全的降血脂藥物。 |
英文摘要 | Background. Hypercholesterolemia is an additional risk factor for patients with noninsulin dependent diabetes mellitus (NIDDM) who have a two-to-three fold higher incidence of coronary heart disease (CHD) as compared to non-diabetic subjects. This study was designed to understand the efficacy and safety of fluvastatin, one of the wholly synthetic HMG-CoA reductase inhibitors, in NIDDM patients with hypercholesterolemia. Methods. A total of 46 subjects with low-density lipoprotein (LDL) holesterol values above 130 mg/dL after dietary control for 6 weeks were randomized to take either fluvastatin 20 mg or a placebo with the evening meal. The dose of medication was doubled six weeks later. Forty patients completed the entire treatment program. Results. Fasting serum glucose and fructosamine values did not change in either group. Compared with those values from placebo, treatment with fluvastatin effectively decreased fasting serum total cholesterol, LDL cholesterol and Apo B concentrations at weeks 6 and 12 in NIDDM patients with hypercholesterolemia. These alterations led to a significant fall in the ratio of LDL cholesterol to HDL cholesterol in the fluvatstatin group (4.1±0.3 vs 2.5±0.2 vs 2.5±0.1, p < 0.01) but not in the placebo group (3.9±0.5 vs 3.6±0.4 vs 3.5±0.2, NS ). There were no significant differences in fasting serum triglyceride, HDL cholesterol and Apo I concentrations either treatment by fluvastatian or placebo. There were no dose effects of fluvatstatin in reducing serum total cholesterol, LDL-cholesterol concentrations at weeks 6 and 12. To evaluate the effect of fluvastatin on platelet function, beta-TG and PF-4 values were measured at baseline, weeks 6 and week 12. Compared with treatment with placebo, there was no alteration in platelet functions following treatment with fluvastatin. Conclusion. Fluvastatin at doses of 20 mg or 40 mg daily are effective and well tolerated in treating Chinese patients with NIDDM and hypercholesterolemia. |
本系統中英文摘要資訊取自各篇刊載內容。