阿昔莫司治疗2型糖尿病伴高脂血症的疗效和安全性及其对糖代谢的影响

Efficacy and safety of acipimox in treatment of patients with type 2 diabetes and hyperlipidemia and its influence on glucose metabolism

目的观察阿昔莫司治疗2型糖尿病伴高脂血症的疗效和安全性以及对糖代谢的影响。方法126例血糖控制稳定的2型糖尿病伴高脂血症患者随机分为高胆固醇(TC)血症组(A组)、混合性高脂血症组(B组)、高三酰甘油组(TG)血症组(C组)和高TG血症但拒调脂治疗组(D组),对A、B、C组患者给予阿昔莫司调脂治疗,D组患者仅行饮食治疗。观察治疗前、后血脂、血糖、糖化血红蛋白(HbA1c)和C肽水平的变化以及药物的不良反应。结果A组治疗后8周时的血清总TC以及空腹血糖(FPG)和餐后2h血糖(2hPG)均较治疗前显著下降(P值均<0.05),同时高密度脂蛋白胆固醇(HDL-C)和C肽水平显著升高(P值分别<0.05、0.01)。B组治疗后8周时的TC和FPG、2hPG均较治疗前显著下降(P值均<0.05),同时HDL-C和C肽水平显著升高(P值分别<0.05、0.01);治疗4周和8周时的TG均较治疗前显著下降(P值均<0.05)。C组治疗后4周和8周时的TG较治疗前显著下降(P值分别<0.05、0.01);治疗后8周时的FPG、2hPG较治疗前显著下降(P值均<0.05),同时HDL-C和C肽水平显著升高(P值分别<0.05、0.01)。D组治疗后4周和8周各项指标与治疗前的差异均无统计学意义(P值均>0.05)。结论阿昔莫司是治疗2型糖尿病伴高脂血症安全、有效的调脂药物,并能改善胰岛B细胞功能。

Objective To evaluate the efficacy and safety of Acipimox in treatment of patients with type 2 diabetes mellitus complicated with heyperlipidemia and the influence of Acipimox on glucose metabolism. Methods A total of 126 patients with type 2 diabetes and hyperlipidemia were enrolled in the present study and they were divided into hypercholesterolemia group （A）, mixed hyperlipidemia group （B） and high triglyceride group （ C and D）. The group A, B and C received Acipimox and group D was received diet treatment for 8 weeks. The changes of cholesterol, triglyceride, HDL-C, fasting plasma glucose （FPG）, 2 h postprandial glucose （2hPG）, C-peptide, HbA1c and adverse reactions were observed. Results TC, FPG and 2hPG were significantly decreased （P〈0.05）, and HDL-C and C-peptide were significantly increased （P〈0.05, P〈0.01） 8 weeks after treatment in A and B group. TG was significantly decreased in group B 4 weeks and 8 weeks after treatment （P〈0.05）. FPG and 2hPG were significantly decreased （P〈0.05）, and HDL-C and C-peptide was significantly increased in C group 8 weeks after treatment （P〈0.05; P〈0.01）. TG was significantly decreased in group C 4 weeks and 8 weeks after treatment （P 〈 0. 05, P 〈 0. 01）. Acipimox lowered plasma triglyceride, cholesterol, FPG, and especially 2hPG, and increased HDL-C and C-peptide in patients with type 2 diabetes mellitus and hyperlipidemia. No severe side effects were found in the patients of 3 groups. The above parameters were similar before and after 4 weeks and 8 weeks treatment in D group （P〉0.05）. Conclusion Acipimox is a safe and effective agent for patients with type 2 diabetes complicated with hyperlipidemia, it can also improve the function of B cells.