西立伐他汀治疗原发性高胆固醇血症随机对照研究  

Efficacy and safety of cerivastatin in the treatment of primary hypercholesterolemia: a multicentre, randomized, double-blind study

作　　者：王水强[1] 贾友宏[1] 陶萍[1] 吴学思[2] 余霞君[3] 陶寿淇[1] 

机构地区：[1]中国医学科学院中国协和医科大学阜外心血管病医院,北京100037 [2]北京安贞医院 [3]解放军总医院

出　　处：《中华心血管病杂志》2000年第4期259-263,共5页Chinese Journal of Cardiology

摘　　要：目的　比较不同剂量的西立伐他汀 (cerivastatin)治疗国人原发性高胆固醇血症的疗效、安全性及耐受性。方法　采用多中心、随机、双盲、安慰剂对照、平行组试验。所有入选者停止其他降脂治疗且饮食控制达美国心脏协会I级 (AHA STEP I)或其相应标准 ,满 4周后 ,接受单盲安慰剂治疗5周 (A期 )。安慰剂期后 ,470例患者随机接受西立伐他汀 0 1mg (n =119)、0 2mg (n =117)、0 3mg(n =116 )或安慰剂 (n =118)治疗 8周 ,每日 1次睡前服药 (B期 )。在B期末 ,低密度脂蛋白 胆固醇(LDL C)较基础值降低≥ 2 0 %的患者继续接受其随机剂量的西立伐他汀或安慰剂治疗 16周 (C期 ) ,以评价长期安全性。治疗前、中、后测定血清血脂指标及其他相关指标。结果　西立伐他汀 0 1mg、0 2mg、0 3mg组治疗 8周与治疗前比较 ,总胆固醇 (TC)分别下降 15 84%、19 0 5 %及 2 1 81% (P均 <0 0 1) ,LDL C分别下降 2 1 83 %、2 6 2 3%及 2 9 6 8% ,(P均 <0 0 1) ,甘油三酯 (TG)分别降低 8 14%、11 11%及 11 5 4% (P均 <0 0 1) ,高密度脂蛋白 胆固醇 (HDL C)分别升高 (0 0 80± 0 16 0 )、(0 0 86±0 146 )及 (0 0 76± 0 147)mmol/L (P均 <0 0 1)。西立伐他汀 0 2mg、0 3mg降低LDL C的能力在女性强于男性 ,0 2mg?Objective To assess the efficacy and safety of cerivastatin in Chinese with primary hypercholesterolemia. Methods The multicentre, randomized, double-blind, placebo-controlled, parallel group trial was conducted in 3 hospitals. After a 5-week single-blind run-in period (period A), 470 patients were randomized to receive cerivastatin 0 1 mg ( n = 119), 0 2 mg ( n = 117), 0 3 mg ( n = 116) or placebo ( n = 118) once daily at bedtime for 8 weeks (period B). At the end of period B, patients with a low density lipoprotein cholesterol (LDL-C) decrease of ≥20% from baseline were continued to receive their randomized dose of cerivastatin or placebo for 16 weeks further for the assessment of long-term safety. Total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), and tryglicerides (TG) were measured before, during and after the treatment. Results Compared with the baseline value, TC, LDL-C and TG were significantly decreased in all cerivastatin groups (all P < 0 01). The mean percentage decrease in TC, LDL-C and TG were 15 84%-21 81%, 21 83%-29 68% and 8 14%-11 54%, respectively, while in the 0 2 mg and 0 3 mg groups cerivastatin decreased LDL-C more in women than in men: 29 7% vs 23 5% for 0 2mg, and 33 7% vs 27 5% for 0 3 mg. HDL-C was significantly increased by (0 080±0 160) mmol/L in the 0 1mg group, (0 086±0 146) mmol/L in the 0 2 mg group and (0 076±0 147) mmol/L in the 0 3 mg group. In the placebo group, there were no significant changes of TC and LDL-C, but TG and HDL-C increased slightly. Cerivastatin had a good safety and tolerability profile. Only one patient in the 0 3 mg group was withdrawn from the study because of abormal liver function tests. No patients were withdrawn due to an elevated CPK level. Conclusions 0 1 to 0 2 mg cerivastatin once daily at bedtime can decrease TC, TG, LDL-C and increase HDL-C significantly. It is an effective, safe, and well tolerated long-term treatment for Chinese patients with primary hyper

关 键 词：原发性高胆固醇血症 药物疗法 西立伐他汀 

分 类 号：R589.2[医药卫生—内分泌]