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目的 评价国产辛伐他汀调整血脂的疗效和安全性。方法 血清总胆固醇(TC)≥5.7 mmol/L的患者按2∶1的比例随机分为试验组(77例)和对照组(36 例)。试验组给予北京万生药业有限公司生产的辛伐他汀(商品名亿辛),对照组给予杭州默沙东公司生产的辛伐他汀(商品名舒降之)。所用药物的初始剂量均为10 mg/d,晚上睡前口服,服用4周后如TC下降未达显效(下降≥20%)或仍≥5.7 mmol/L者,将剂量增至20mg/d,总疗程8周。观察治疗后血清TC、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL C)和低密度脂蛋白胆固醇(LDL C)水平的变化;安全性指标观察血清丙氨酸转氨酶(ALT)、肌酸磷酸激酶(CPK)和肌酐(Cr)。结果 治疗前两组血脂各指标间的差异无显著性(P>0.57)。治疗后4 周和8 周与治疗前进行组内比较,两组TC、TG、LDL C下降值的差异的有显著性(P<0.01)。治疗8 周试验组TC、TG和LDL C分别下降22%、16%和20%,对照组分别下降26%、18%和26%;两组下降值的差异无显著性(P>0.05)。两组治疗前、后HDL C无明显改变(P>0.05)。试验组和对照组降低胆固醇的总有效率分别为84.7%和88.2%。试验组ALT及CPK异常升高超过正常上限者各1例,升高幅度在正常高限的1 倍以内,停药后2 周复查自行恢复正常。结论 与进口制剂(舒降之)相比,国产辛伐他汀(亿辛)是
Objective To evaluate the efficacy and safety of domestic simvastatin in the regulation of blood lipids. Methods Patients with serum total cholesterol (TC) ≥5.7 mmol / L were randomly divided into experimental group (77 cases) and control group (36 cases) according to the ratio of 2: 1. The experimental group was given simvastatin (product name: Yixin) produced by Beijing Wansheng Pharmaceutical Co., Ltd., while the control group was given Simvastatin (product name: Shujiangzhi) produced by Hangzhou Merck’s company. The initial dose of the drugs used were 10 mg / d, orally taken at bedtime before going to bed, after 4 weeks of taking if the TC was not significantly reduced (≥ 20% decline) or still ≥ 5.7 mmol / L, the dose increased to 20mg / d, the total course of treatment 8 weeks. The levels of serum TC, triglyceride (TG), high density lipoprotein cholesterol (HDL C) and low density lipoprotein cholesterol (LDL C) were observed after treatment. The safety indexes were observed in serum alanine aminotransferase (ALT) Acid phosphate kinase (CPK) and creatinine (Cr). Results There was no significant difference between the two groups before treatment (P> 0.57). The differences of TC, TG and LDL C between the two groups were significant at the 4th and 8th week after treatment (P <0.01). The levels of TC, TG and LDL C decreased by 22%, 16% and 20% in the experimental group and 26%, 18% and 26% in the control group respectively after 8 weeks of treatment. There was no significant difference between the two groups (P> 0.05). HDL C before and after treatment in both groups had no significant change (P> 0.05). The total effective rate of cholesterol lowering in experimental group and control group was 84.7% and 88.2% respectively. In the experimental group, the abnormal increase of ALT and CPK exceeded the upper limit of normal in 1 case. The increase range was within 1 times of the normal high limit. Two weeks after the withdrawal, self-recovery was normal. Conclusion Compared with the imported preparation (SHR), domestic simvastatin (YIXIN) is