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目的 评价国产洛伐他汀的疗效和安全性。方法 对 15 8例原发性高胆固醇血症患者按 2∶1随机分试验组 (E组 ) 10 1例服国产洛伐他汀和对照组 (C组 ) 5 7例服进口美降之治疗 ,药物剂量 (2 0～ 40 )mg/d ,疗程 2个月。结果 E组降低血清总胆固醇 2 1 7%± 9 3%、甘油三酯 6 1%± 2 5 8% ,升高血清高密度脂蛋白 -胆固醇 9 6 %± 16 9% ,与C组相似 ;E组降低血清低密度脂蛋白 -胆固醇 32 9%± 15 % ,稍优于C组 (P <0 0 5 )。两组各有 1例胃肠道反应而停药 ,E组有 8例 (7 9% )、C组有 4例 (7 0 % )出现轻度中上腹部不适。结论 国产洛伐他汀具有与国外同类产品相似的疗效 ,未见明显的毒副作用。
Objective To evaluate the efficacy and safety of domestic lovastatin. Methods A total of 158 patients with primary hypercholesterolemia were treated with imported melatonin in a ratio of 2: 1 in randomized controlled trial group (group E): 101 domestic lovastatin and 57 in control group (group C) Drug dose (20 ~ 40) mg / d, course of treatment for 2 months. Results In group E, serum total cholesterol 21.7% ± 93%, triglyceride 61% ± 25 58% and serum high density lipoprotein-cholesterol 96% ± 16 9% were increased, similar to group C; E group decreased serum LDL-cholesterol 32 9% ± 15%, slightly better than C group (P <0 05). One patient in each group discontinued gastrointestinal reactions, eight patients (79%) in group E, and four patients (70%) in group C who developed mild middle-to-upper abdominal discomfort. Conclusion Domestic lovastatin has similar efficacy with similar foreign products, no obvious side effects.