小剂量普伐他汀与非诺贝特联合治疗混合型高血脂症临床疗效及安全性  

Efficacy and Safety of Combination Therapy with Low-dose Pravastatin and Fenofibrate for Combined Hyperlipidemia

作　　者：孙晓红[1] 彭晓玲[1] 朱蕾[1] 

机构地区：[1]深圳市孙逸仙心血管医院心内科,广东深圳518021

出　　处：《中华高血压杂志》2007年第5期387-391,共5页Chinese Journal of Hypertension

摘　　要：目的探讨小剂量普伐他汀与非诺贝特联合应用治疗混合型高血脂症的临床疗效及安全性。方法混合型高血脂症患者189例,随机分为3组,即普伐他汀组(10mg/d,n=64)、非诺贝特组(200mg/d,n=63)、联合治疗组(普伐他汀10mg/d+非诺贝特200mg/d,n=62),治疗12周;12周时单药治疗血脂水平未全部达标者再随机分为3组,即联合治疗组、普伐他汀20mg治疗组及非诺贝特组,再治疗12周。观察治疗前后主要血脂水平的变化率、达标率及不良反应。结果(1)12周时联合治疗组血清总胆固醇(TC)、低密度脂蛋白胆固醇LDL-C、三酰甘油(TG)下降的幅度及血清高密度脂蛋白胆固醇(HDL-C)升高的幅度均高于单独用药组(P值均<0.01);TC、LDL-C、TG3项全部达标率也高于单独用药组(P均<0.01)。(2)单独用药血脂参数未全部达标者(n=35)改为联合治疗组治疗12周后TC及LDL-C下降的幅度与普伐他汀20mg组比较,差异无统计学意义,而降低TG及升高HDL-C幅度高于普伐他汀20mg组(P值均<0.01);联合治疗组与单用非诺贝特组比较,降低TC、LDL-C、TG及升高HDL-C的幅度高于非诺贝特组(P值<0.01或<0.05);联合用药组3项全部达标率为44%,而普伐他汀20mg组及非诺贝特组全部达标为21%、17%(P值均<0.01)。(3)联合治疗的不良反应与单独用药相比没有明显增加。结论小剂量普伐他汀(10mg/d)与非诺贝特(200mg/d)联合治疗混合型高血脂症,较单独用药更有效、更全面地改善各项血脂水平,具有良好的安全性和耐受性。Objective The aim of this study was to evaluate the efficacy and safety of combination therapy with low-dose pravastatin and fenofibrate in patients with combined hyperlipidemia. Methods One hundred eighty nine patients with combined hyperlipidemia were randomly assigned to receive 10 mg pravastatin （n= 64） or 200 mg fenofibrate （n=63）, or a combination of 10 mg pravastatin and 200 mg fenofibrate （n=62） for 12 weeks. The patients in the monotherapy groups （n=35） whose lipid levels were not controlled after 12 weeks were randomly assigned to receive 20 mg pravastatin, or 200 mg fenofibrate, or a combination of 10 mg pravastatin and 200 mg fenofibrate for another 12 weeks. Lipid levels and adverse effects were assessed. Results After 12 weeks treatments, serum TC, LDL-C and TG levels were reduced and HDL-C was increased more significantly in combination therapy group, compared with 2 monotherapy groups （all P〈0.01）. Combined treatment decreased TG and increased HDL-C more pronouncedly than pravastatin alone, with no difference in TC and LDL-C between them; furthermore, combined treatment decrease TC, LDL-C, and TG and increased HDL-C greater than fenofibrate alone. The overall rate of achievment for TC, LDL-C and TG target goal was 44% in the combination therapy group, compared with 22% （P〈0. 01） and 17%（P〈0.01 ） in pravastatin （20 mg/d） and fenofibrate group, respectively. Combined treatments were well tolerated with no increase in adverse events. Conclusion Combination therapy with low-dose pravastatin （10 mg/d） and fenofibrate （200 mg/d） is more effective than pravastatin or fenofibrate monotherapy in patients with combined hyperlipidemia, and is generally safe and well tolerated.

关 键 词：混合型高血脂症 普伐他汀 非诺贝特 联合治疗 

分 类 号：R589.2[医药卫生—内分泌]