氟伐他汀与非诺贝特联合和大剂量氟伐他汀强化治疗混合型高脂血症的临床观察

Fluvastatin and fenofibrate and fluvastatin of high dosage in management of hyperlipidemia

目的探讨氟伐他汀与非诺贝特联合应用以及大剂量氟伐他汀强化治疗混合型高血脂症的临床疗效及安全性。方法经氟伐他汀(40 mg.d-1)治疗3个月以上不能达标的混合型高血脂症患者70例,随机分为2组,即大剂量氟伐他汀组(80 mg.d-1,n=35)和联合治疗组(氟伐他汀40 mg.d-1+非诺贝特200 mg.d-1,n=35),治疗12周;观察治疗前后主要血脂水平的变化及不良反应。结果12周时两组血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)下降明显,大剂量氟伐他汀组较联合治疗组稍明显,但差异无统计学意义(P>0.05);联合用药组三酰甘油(TG)下降的幅度及血清高密度脂蛋白胆固醇(HDL-C)升高的幅度明显高于大剂量氟伐他汀组(P<0.05);联合治疗组3项指标(TC、LDL-C、TG)均达标的总达标率高于大剂量氟伐他汀组(P<0.05);联合治疗组合不良反应与大剂量氟伐他汀组相比没有明显增加。结论氟伐他汀(40 mg.d-1)与非诺贝特(200 mg.d-1)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 To evaluate the efficacy and safety of combination therapy with fluvastatin and fenoiibrate and high dosage of fluvastatin in patients with combined hyperlipidemia. Methods Seventy patients with combined hyperlipidemia were randomly assigned to receive 80 mg fluvastatin （n = 35 ）or a combination of 40 mg fluvastatin and 200 mg fenofibrate （n = 35 ） for 12 weeks. Lipid levels and adversese were assessed. Results After 12 weeks treatment,serum TC and LDL-C levels were reduced a little more in high dose of fluvastatin group than in combination therapy group, but there was no significant difference between them （P 〉 0.05 ）. The level of TG decreased and HDL-C increased more significantly in combination therapy group than in high dose of fluvastatin group （P 〈0.01 ）. The success rate of TC ,LDL-C and TG control in combination therapy group was superior to high dosage of fluvastatin（P 〈 0.05 ）. Combined treatment and the high dose of fluvastatin treatment were well tolerated with no increase in adverse events. Conclusion Combination therapy with fluvastatin （40 mg·d^-1） and fenofibrate （200 mg·d^-1） is more effective than fluvastatin monotherapy in patients with combined hyperlipidemia, and is generally safe and well tolerated.