目的 考察不同剂量辛伐他汀联合非诺贝特胶囊治疗2型糖尿病合并高脂血症的临床疗效及安全性.方法 天津市第五中心医院2010年6月—2014年4月收治的2型糖尿病合并高脂血症患者110例,随机分为高剂量组和低剂量组,每组55例.两组患者均口服非诺贝特胶囊,1粒/次,3次/d.高剂量组口服辛伐他汀片40 mg/次,1次/d;低剂量组口服辛伐他汀片20 mg/次,1次/d.两组均连续治疗8周.比较两组患者的血脂水平、血液安全指标和不良反应发生率.结果 治疗后,两组患者血脂水平均得到显著改善,其中,总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)较治疗前显著降低,且高密度脂蛋白胆固醇(HDL-C)较治疗前显著升高,同组治疗前后比较差异有统计学意义(P<0.05).治疗后,高剂量组患者的丙氨酸氨基转氨酶(ALT)、血尿素氮(BUN)及肌酐(Cr)均较治疗前显著升高,而低剂量组BUN较治疗前降低,Cr较治疗前升高,同组治疗前后差异均有统计学意义(P<0.05);治疗后,低剂量组ALT、BUN、Cr水平低于高剂量组,两组比较差异有统计学意义(P<0.05、0.01).高、低剂量组不良反应发生率分别为9.09%、7.27%,两组不良反应发生率比较差异有统计学意义(P<0.05).结论 低剂量辛伐他汀联合非诺贝特治疗2型糖尿病合并高脂血症具有较好的临床疗效,可较好地控制患者血脂水平,并降低患者肾脏代谢负担和不良反应发生率.
Objective To investigate the clinical efficacy and safety of simvastatin with different doses combined with fenofibrate in treatment of type 2 diabetes complicated with hyperlipidemia. Methods Patientswith type 2 diabetes complicated with hyperlipidemia from June 2010 to April 2014 (110 cases) were randomly divided into high dose and low dose groups (n = 55). Patients in two groups were po administered with Fenofibrate Capsules, 1 grain/time, three times daily. Patients in high dose group were po administered with Simvastatin Tablets, 40 mg/time, once daily, while patients in low dose group were po administered with Simvastatin Tablets, 20 mg/time, once daily. The patients in the two groups were treated for 8 weeks. The levels of blood lipid, indexes of blood safety and incidence of adverse reactions in two groups were compared. Results After treatment, levels of blood lipid in two groups were improved significantly, and TC, TG, and LDL-C were significantly reduced, while HDL-C was significantly higher, and the difference was statistically significant before and after the treatment in the same group (P < 0.05). After treatment, ALT, BUN, and Cr of high dose group were significantly higher, while BUN of low dose group was lower and Cr was higher, and the difference was statistically significant before and after the treatment in the same group (P < 0.05). After treatment, ALT, BUN, and Cr in low dose group were lower than those in the high dose group, and there were differences between the two groups (P < 0.05, 0.01). Incidence of adverse reactions in high and low dose group were 9.09% and 7.27%, respectively, and there were differences between the two groups (P < 0.05). Conclusion Low dose of simvastatin combined with fenofibrate has a good clinical effect in treatment of type 2 be better control levels of blood lipid, which can reduce the metabolism burden of kidney and the incidence of adverse reactions.