国产辛伐他汀治疗高脂血症的临床观察  

The efficacy and safety of domestic simvastatin in patients with hypercholesterolemia

作　　者：伍卫[1] 张旭明[1] 蔡乃绳[2] 过鑫昌[3] 周淑娴[1] 朱文清 谢玉才[3] 王敏华 

机构地区：[1]中山大学孙逸仙纪念医院心内科,广州510120 [2]上海医科大学中山医院心内科,上海200032 [3]上海第二医科大学瑞金医院心内科,上海200025

出　　处：《中国药学杂志》2000年第3期199-201,共3页Chinese Pharmaceutical Journal

摘　　要：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 evaluate the efficacy and safety of domestic simvastatin (Shenzhen Boda Natural Product Co.Ltd & Shanghai Yanan Pharmaceutical Factory) in treating patients with hypercholesterolemia.METHODS:Totally 165 ptients [85 male,80 famale,mean age (58.9±9.2) years],with 103 patients in domestic simvastatin group and 62 patients in Zocor (MSD) group,were involved in a single blind randomized parallel controlled clinical trial with simvastatin or Zocor 10 mg daily for 8 weeks.Total cholesterol (TC),LDL cholesterol (LDL C),and triglycerides (TG) at baseline were (7.00±0.88) mmol·L -1 ,(4.45±1.12)mmol·L -1 and (2.13±0.87) mmol·L -1 ,respectively.RESULTS:Patients in both groups had significant reduction in TC,LDL C,TG and ApoB (P <0.01).Domestic simvastatin resulted in -25.0%,-27.6% and -24.6% change from baseline of TC,LDL C and TG,respectively.Zocor resulted in -26.8%,-34.4% and -17.7% change from baseline of TC,LDL C and TG,respectively.The frequency of adverse effects were 4.9% in domestic simvastatin group and 4.8% in Zocor group.The side effects including fatigue,sleepless and abdominal distension were mild in both groups.None serious adverse effects were occurred in both groups.CONCLUSION:Domestic simvastatin had a similar efficacy with Zocor for treating patients with hypercholesterolemia.The tolerance in both groups was good.

关 键 词：辛伐他汀 高脂血症 药物疗法 

分 类 号：R589.205[医药卫生—内分泌] R972.6[医药卫生—内科学]