联合应用辛伐他汀和非诺贝特治疗混合性高脂血症的疗效及安全性观察

Efficacy and safety of combination therapy with simvastatin and fenofibrate for combined hyperlipidemia

目的 探讨联合应用辛伐他汀和非诺贝特治疗混合性高脂血症的临床疗效及安全性。方法 共入选 221例混合性高脂血症患者,随机分入辛伐他汀组 (10mg/d,n=72)、非诺贝特组 (200mg/d,n=68)和联合治疗组(辛伐他汀 10mg/d+非诺贝特 200mg/d,n=81),疗程均为 6个月。观察治疗前后主要血脂参数的变化率、达标率、总有效率以及不良反应。结果 (1)联合治疗组血脂参数变化率最显著,血清总胆固醇(TC)、低密度脂蛋白胆固醇 (LDL C)和甘油三酯 (TG)分别下降 30%、37%和 56%,而血清高密度脂蛋白胆固醇(HDL C)升高 24%,其降低TG和升高HDL C的能力不仅明显优于辛伐他汀组,而且也明显优于非诺贝特组(P值均小于 0 01)。(2)按我国“血脂异常防治建议”的目标,联合治疗组TC、LDL C和TG的达标率分别为 51%、55%和 61%,三项全部达标者占45%,明显高于单药治疗组(P值均小于 0 01),其治疗总有效率也明显优于单药治疗。(3)联合治疗组不良反应的发生率和单药治疗组相比差异无统计学意义 (P值均大于 0 05)。结论 本研究结果提示, 非诺贝特(200mg/d)与小剂量辛伐他汀(10mg/d)联合治疗可以更全面地改善混合性高脂血症患者的血脂异常,较单药治疗更有效,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 simvastatin and fenofibrate in patients with combined hyperlipidemia Methods A total of 221 patients with combined hyperlipidemia were randomly assigned to receive 10 mg simvastatin ( n =72) or 200 mg fenofibrate ( n =68), or a combination of 10 mg simvastatin+200 mg fenofibrate ( n =81) for 6 months Lipid profiles, physical and laboratory investigations for adverse effects were assessed Results (1)Combination treatment were more effective in normalizing lipid profile than any monotherapy Serum TC, LDL C, and TG were reduced by 30%, 37% and 56% respectively, whilst HDL C significantly increased by 24%(all P <0 01) The improvement in TG and HDL C achieved by combination treatment was superior to fenofibrated or simvastatin alone (2)The success rate of TC, LDL C and TG control in the combination therapy group were 51%, 55% and 61% respectively, with an overall success rate (all three together) of 45%, which was superior to either drug given as monotherapy (3)All treatments were well tolerated with no increase in adverse events for combination therapy versus monotherapy Conclusion The results of this study demonstrated that combination therapy with fenofibrate(200 mg/day)and low dose simvastatin(10 mg/day)is more effective than monotherapy in patients with combined hyperlipidemia, and is generally safe and well tolerated