国产辛伐他汀治疗原发性高胆固醇血症的临床观察

Clinical Evaluation of Simvastatin Made in China Treatement of Primary Hypercholestrolemia

为探讨国产辛伐他汀对原发性高胆固醇血症的调脂作用,本文观察了42例高胆固醇血症患者,根据血清TC水平随机按1:1分验证组及对照组各13例,另设16例开放验证(验证组共29例),验证组服用国产辛伐他汀;对照组均服用进口舒降之,疗程均为8周.验证组与对照组均服药8周,降血清总胆固醇(TC)分别为24.6%和24.1%;降低密度脂蛋白胆固醇(LDL-C)分别为34.7%和34.9%;降甘油三脂(TG)分别为24. 9%和23.5%;降(TC-HDL-C)/HDL-C分别为41.8%和41.3%;升高高密度脂蛋白胆固醇(HDL-C)分别为15.5%和16.1%;与治疗前比均有极显著差异(P均<0.01).验证组及对照组8周总有效率TC分别为97%和92%;TG分别为70%和63%;(TC-HDL-C)/HDL-C分别为97%和100%;HDL-C两组均为100%.其降低及升高幅度两组间均无明显差异(P均>0.05).服药过程中验证组出现肌肉酸痛和轻微头痛各1例,对照组出现肌肉酸痛及肩关节痛各1例,未予治疗,自行缓解,均比较顺利地完成疗程,提示国产辛伐他汀是一种高效,安全调脂剂.

To determine the role of simvastatin which was made in China for patients with primary hypercholestrolemia. Twenty-nine patients with hypercholestrolemia were treated with simvastatin (made in China) as test group and thirteen patients were treated with zocor (simvastatin made in American) as control group for 8 weeks, each took simvastation 10 rng/day. The results showed that serum level of total cholesterol (TC), triglyceride(TG), low density lipoprotein cholesterol(LDL-C) and the ratio of (TC-HDL-O/HDL-C were reduced by 24. 6%, 24. 9%, 34. 7% and 41. 3% in control group espectively, the serum level of high density lipoprotein cholesterol (HDL-C) was increased by 15. 5% in test group and 16. 1% in control group. The serun level of TC, TG, LDL-C and the ratio of (TC-HDL-C)/HDL-C were significantly lower after treatment than those before treatment (all P<0. 01) and the serum level of HDL-C was significantly higher after treatment than that before treatment (P<0. 01) in two groups. The total effectiveness rates of simvastatin for TC, TG, HDL-C and (TC-HDL-C)/HDL-C were 97%, 70%, 100% and 97% in test group and 92% , 63% , 100% and 100% in control group respectively. There were no significantly between two groups (F>0. 05). The results showed that simvastatin made in China is a safe and effective lipid modulator.