摘要
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)
Objective To assess the efficacy and safety of Yi Xin(simvastatin made in China)in patients with lipidemia. Methods A prospective, randomised study was performed in patients with lipidemia (Total cholesterol ≥5.7mmol/L). 113 cases were enrolled in this study. The patients received either Yi Xin(simvastatin made in China, n=77)or Zocor (simvastatin made in USA) with the initial dose of 10mg/qd for 4 weeks. If the level of TC could not decrease for more than 20%, or remain ≥5.7 mmol/L, increase the doses of Yi Xin and Zocor separately to 20 mg/qd for another 4 weeks. Serum TC,TG (triglyceride), HDL-C(high density lipoprotein cholesterol), LDL-C(low density lipoprotein cholesterol), SGPT(glutamic-pyruvic transaminase), CPK(creatine phosphokinase) and creatinine were evaluated respectively. Results TC、TG and LDL-C decreased significantly after treament at week 4 and week 8 in both group. The decrement rates were 22%,16%and 20% in Yi Xin group; 26%,18% and 26% in Zocor group respectively. The total effective rates were 84.7% in Yi Xin group and 88.2% for Zocor group. The adverse reaction was slight. Conclusion Yi Xin is an effective and safe drug in treating patients with lipidemia after comparison with Zocor.
出处
《上海医学》
CAS
CSCD
北大核心
2005年第4期284-286,共3页
Shanghai Medical Journal
