辛伐他汀联合非诺贝特治疗老年2型糖尿病并混合型高脂血症患者的临床疗效观察

Curative Effect of Simvastatin Combined with Fenofibrate on Senile Patients with Type 2 Diabetes and Hyperlipidemia

目的探讨辛伐他汀联合非诺贝特治疗老年2型糖尿病并混合型高脂血症患者的疗效和安全性,并观察主要心血管事件发生情况。方法 65岁以上老年2型糖尿病并混合型高脂血症患者198例,随机分为单用辛伐他汀片组(单药组)95例,给予辛伐他汀片20mg/d;辛伐他汀片联合非诺贝特胶囊组(联合组)103例,给予辛伐他汀片20mg/d,非诺贝特胶囊100mg/d。疗程均为6个月。观察两组治疗前和治疗后1、3、6个月血脂参数变化,达标率、不良反应及主要心血管事件例数。结果单药组除三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)治疗后与治疗前无明显改善外(P>0.05),血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)均有明显降低(P<0.05)。联合组TG、TC及LDL-C治疗后均有显著降低,HDL-C明显升高(P<0.05);与单药组比较,联合组TG、TC及LDL-C降低的幅度和HDL-C升高幅度更大(P<0.05或P<0.01),治疗后3、6个月,联合组TG、TC、LDL-C、HDL-C达标率和四项达标率更高(P<0.05);心血管事件较单药组明显减少,差异有统计学意义(χ~2=12.78,P<0.01);两组患者不良反应发生率相比差异无统计学意义(χ~2=0.28,P>0.05)。结论辛伐他汀联合非诺贝特治疗老年2型糖尿病并混合型高脂血症患者有良好的安全性和有效性,能减少主要心血管事件发生。

Objective To discuss the curative effect of simvastatin combined with fenofibrate on senile patients with type 2 diabetes and mixed hyperlipidemia and the safety and to oberve the occurrence of main cardiovascular events. Methods 198 senile patients over65 years old with type 2 diabetes and mixed hyperlipidemia were randomly divided into 2 groups： single group（n=95） and combined group（n=103）; administration of simvasatin, 20mg/d, was applied to all the patients in both groups while fenofibrate, 100mg/d, was added to patients in combined group; the treatment in both groups lasted for 6 months; an observation was made to the changes of blood lipid index, standard-reaching rate, the occurrence of side effects and case number of main cardiovascular events. Results The levels of TG and HDL-C in patients in single group was not obviously improved before and after treatment（P〉0.05） but the levels of TC and LDL-C after treatment were lower than those before treatment（P〉0.05）; the levels of TG, TC and LDL-C of the patients in combined group were much lower after treatment than those before treatment while level of HDL-C increased obviously（P〉0.05）; the decrease of the levels of TG, TC and LDL-C and the increase of the level of HDL-C in combined group were bigger than those in single group（P〉0.05 or P〉0.05）; the standard-reaching rates of TG, TC, LDL-C and HDL-C in combined group 3 and 6 months after treatment were higher than those in single group（P〉0.05）; the occurrence of main cardiovascular events in combined group decreased much more than that in single group, the difference between the 2 groups was of statistical significance（χ~2=12.78, P〉0.01）; there existed no statistical difference in the occurrence of side effects between the 2 groups（χ~2=0.28, P〉0.05）. Conclusions Simvatatin combined withfenofibrate is effective with safety on senile patients with type 2 diabetes and mixed hyperlipidemia, which can reduce the occurrence of main cardiovascular events.