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目的 :观察国产辛伐他汀 (泽之浩 )调血脂的临床疗效与不良反应。方法 :高脂血症 1 6 5例 ,男 85例 ,女 80例。平均年龄 (5 8.9± 9.2 )岁。治疗前平均血清总胆固醇 (TC) (7.0 0± 0 .88)mmol·L-1,低密度脂蛋白胆固醇 (LDL C) (4.45± 1 .1 2 )mmol·L-1,三酰甘油 (TG) (2 .1 3± 0 .87)mmol·L-1。试验组 1 0 3例 ,po泽之浩。对照组 6 2例 ,po进口辛伐他汀 (舒降之 )。二组均用辛伐他汀剂量 1 0mg·d-1,疗程 8周。结果 :治疗后两组血清TC ,LDL C ,TG及ApoB均明显降低 (P <0 .0 1 )。试验组血清TC ,LDL C ,TG分别下降 2 5 .0 % ,2 7.6 % ,2 4.6 % ;对照组分别下降 2 6 .8% ,34 .4% ,1 7.7%。治疗前后两组血清HDL C ,ApoA1无明显变化。试验组不良反应的发生率为 4.9% ,对照组为 4.8% ,症状主要包括乏力、失眠和腹胀 ,程度轻微 ,未发现严重毒副反应。结论 :泽之浩能有效降低血清TC ,LDL C ,TG以及ApoB水平 ,对血清HDL C ,ApoA1无明显不良影响 ,与舒降之的临床疗效比较无明显差异。患者耐受性良好。
Objective: To observe the clinical efficacy and side effects of domestic simvastatin (Ze Zhi Hao) in regulating blood lipid levels. Methods: 165 cases of hyperlipidemia, 85 males and 80 females. The average age (5 8.9 ± 9.2) years old. Before treatment, mean serum total cholesterol (TC) was (7.0 0 ± 0.88) mmol·L -1, low density lipoprotein cholesterol (LDL C) was 4.45 ± 1.12 mmol·L -1, triglyceride TG) (2.13 ± 0.87) mmol·L-1. The experimental group of 103 cases, po Ze-ho. Control group, 62 cases, po imported simvastatin (SHR). The two groups were treated with simvastatin 10 mg · d-1 for 8 weeks. Results: The levels of TC, LDL C, TG and ApoB in the two groups were significantly decreased after treatment (P <0.01). The levels of TC, LDL C and TG in the experimental group decreased by 25.0%, 26.6% and 22.6% respectively, while those in the control group decreased by 26.8%, 34.4% and 17.7%, respectively. Serum HDL C and ApoA1 in the two groups had no significant changes before and after treatment. The incidence of adverse reactions in the experimental group was 4.9% and that in the control group was 4.8%. The symptoms mainly included fatigue, insomnia and abdominal distension. The severity was mild and no serious side effects were found. Conclusion: Ze Zhi Hao can effectively reduce serum TC, LDL C, TG and ApoB levels, serum HDL C, ApoA1 no significant adverse effects, and Shu peace of the clinical efficacy was no significant difference. Patients are well tolerated.