Englisch W, Beckers C, Unkauf M, Ruepp M, Zinserling V
Novartis Consumer Health GmbH, Munich, Germany.
Arzneimittelforschung. 2000 Mar;50(3):260-5. doi: 10.1055/s-0031-1300196.
Efficacy and tolerability of artichoke dry extract (drug/extract ratio 25-35:1, aquous extract, CY450) as coated tablets containing 450 mg extract (tradename: Valverde Artischocke bei Verdauungsbeschwerden) was investigated in the treatment of hyperlipoproteinemia and compared with placebo. 143 adult patients with initial total cholesterol of > 7.3 mmol/l (> 280 mg/dl) were included in a double blind, randomized, placebo controlled, multi-center clinical trial. Patients received 1,800 mg artichoke dry extract per day or placebo over 6 weeks. Changes of total cholesterol and LDL-cholesterol from baseline to the end of treatment showed a statistically significant superiority (p = 0.0001) of artichoke dry extract over placebo. The decrease of total cholesterol in the CY450 group was 18.5% compared to 8.6% in the placebo group. LDL-cholesterol decrease in the CY450 group was 22.9% and 6.3% for placebo. LDL/HDL ratio showed a decrease of 20.2% in the CY450 group and 7.2% in the placebo group. There were no drug related adverse events during this study indicating an excellent tolerability of artichoke dry extract. This prospective study could contribute clear evidence to recommend artichoke dry extract CY450 for treating hyperlipoproteinemia and, thus, prevention of atherosclerosis and coronary heart disease.
对含有450毫克提取物（商品名：Valverde Artischocke bei Verdauungsbeschwerden）的洋蓟干提取物（药物/提取物比例为25 - 35:1，水提取物，CY450）肠溶片治疗高脂蛋白血症的疗效和耐受性进行了研究，并与安慰剂进行比较。143名初始总胆固醇> 7.3 mmol/l（> 280 mg/dl）的成年患者纳入一项双盲、随机、安慰剂对照、多中心临床试验。患者在6周内每天接受1800毫克洋蓟干提取物或安慰剂。从基线到治疗结束时，总胆固醇和低密度脂蛋白胆固醇的变化显示洋蓟干提取物在统计学上显著优于安慰剂（p = 0.0001）。CY450组总胆固醇下降18.5%，而安慰剂组为8.6%。CY450组低密度脂蛋白胆固醇下降22.9%，安慰剂组为6.3%。CY450组低密度脂蛋白/高密度脂蛋白比值下降20.2%，安慰剂组下降7.2%。本研究期间未出现与药物相关的不良事件，表明洋蓟干提取物耐受性良好。这项前瞻性研究可为推荐CY450洋蓟干提取物治疗高脂蛋白血症以及预防动脉粥样硬化和冠心病提供明确证据。
