泰脂安与半量辛伐他汀联用对糖尿病高脂血症的疗效观察

The efficacy of Taizhi′an with half dose of simvastatin in treating hyperlipidemia in diabetic patients

目的:评价泰脂安与半量辛伐他汀联合应用治疗糖尿病并发高血脂患者的疗效和安全性。方法:120例2型糖尿病并高血脂患者随机分为3组:泰脂安加辛伐他汀10mg组(A组)40例,口服泰脂安胶囊0.9g,tid,同时睡前服用辛伐他汀10mg;辛伐他汀20mg组(B组)40例,睡前服用辛伐他汀20mg;泰脂安加辛伐他汀20mg组(C组)40例,口服泰脂安胶囊0.9g,tid,同时睡前服用辛伐他汀20mg。3组均治疗12周,观察治疗前后血脂的变化和不良反应。结果:A组TC、TG、LDL-C依次下降28.8%,18.2%,26.3%,B组依次下降29.4%,19.4%,24.6%,C组依次下降31.8%,20.6%,28.2%,3组HDL-C升高分别为23.5%,29.4%,29.8%,治疗前后差异均有显著性(均P<0.05),但组间差异无显著性(均P>0.05),糖化血红蛋白治疗前后无明显变化。A组未见明显不良反应,而B组和C组分别有7.5%和5%的患者出现转氨酶升高。结论:对糖尿病并发高血脂患者的血脂异常,泰脂安与辛伐他汀10mg.d-1联用同辛伐他汀20mg.d-1单用或与泰脂安联用具有相似的调脂作用,但前者可减轻辛伐他汀20mg.d-1所引起的不良反应,安全性好。

OBJECTIVE To evaluate the effectiveness and safety of Taizhi＇an combined with half dose of simvastatin in the management of hyperlipidemia in diabetic patients. METHODS 120 cases of type 2 diabetics with hyperlipidemia were randomized into three groups, 40 in each group. Patients in group A took orally Taizhi＇an capsules at the dose of 0. 9 tid plus simvastatin 10 mg at bedtime. Subjects in group B were treated with only simvastatin 20 mg at bedtime. Individuals in group C were given Taizhi＇an capsules at the dose of 0.9 tid plus Simvastatin 20 mg at bedtime. Three regimen lasted 12 weeks. Before and after the study the change of blood lipid level and adverse effects were investigated. RESULTS The serum levels of TC, TG and LDL-C were decreased by 28. 8%, 18.2% and 26.3% in group A; by 29. 4%,19. 4% and 24. 6% in group B; by 31.8%, 20.6%,28.2% in group C, respectively. Whereas, HDLC was increased by 23.5% in Group A, 29.4% in group B and 29.8% in group C, respectively. All these changes were statistically significant before and after treatment （P〈0.05）, but there was no difference among three groups （P〉0.05）. There was no significant change in HbA1c. Patients in Group A did not develop any untoward reactions. However, At.T were found higher above normal range in 7.5% patients in group B and 5% in group C. CONCLUSION In treating hyperlipidemia in diabetics combination of Taizhi＇an with simvastatin 10 mg·d^-1 achieved satisfying effect similar to simvastatin 20 mg·d^-1 alone or plus Taizhi＇an But the combination therapy conducted in group A had better safety, since it could overcome the .side effect resulted from simvastatin seen in group B and group C.