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目的评价国产与进口匹伐他汀治疗原发性高胆固醇血症的疗效与安全性。方法 64例患者随机分为国产组与进口组,分别给予国产匹伐他汀片、进口匹伐他汀片治疗,观察疗程为8周,评价其疗效与安全性。结果治疗8周后2组总胆固醇(TC)、低密度脂蛋白-胆固醇(LDL-C)水平与治疗前相比均显著降低(P<0.01);国产组与进口组LDL-C达标率分别为78.1%和81.3%;但2组高密度脂蛋白-胆固醇(HDL-C)和三酰甘油(TG)水平治疗前后无明显变化(P>0.05)。治疗前后2组间TC、LDL-C、HDL-C、TG水平差异无统计学意义,不良反应发生率差异无统计学意义(P>0.05)。结论国产匹伐他汀与进口匹伐他汀疗效相当,安全性良好。
Objective To evaluate the efficacy and safety of domestic and imported pitavastatin in the treatment of primary hypercholesterolemia. Methods Sixty-four patients were randomly divided into domestic group and imported group. Patients were given domestic pitavastatin tablets and imported pitavastatin tablets. The course of treatment was 8 weeks, and its efficacy and safety were evaluated. Results After 8 weeks of treatment, the levels of total cholesterol (TC) and low density lipoprotein-cholesterol (LDL-C) were significantly lower in both groups than those before treatment (P <0.01) Were 78.1% and 81.3% respectively. However, no significant changes were found in the levels of HDL-C and triglyceride between the two groups before and after treatment (P> 0.05). There were no significant differences in TC, LDL-C, HDL-C and TG levels between the two groups before and after treatment, with no significant difference in the incidence of adverse reactions (P> 0.05). Conclusion Domestic pitavastatin and imported pitavastatin have similar efficacy and good safety.