血糖控制不佳的超重或肥胖2型糖尿病患者加用吡格列酮二甲双胍与基础胰岛素的疗效比较及对代谢指标的影响

目的 探讨血糖控制不佳的超重或肥胖2型糖尿病患者加用吡格列酮二甲双胍或基础胰岛素的疗效，以及两者对患者其他代谢指标的影响。方法 纳入血糖控制不佳的超重或肥胖2型糖尿病患者153例，随机分为两组：吡格列酮二甲双胍组（77例）和基础胰岛素组（76例），分别在原有治疗药物的基础上加用吡格列酮二甲双胍或甘精胰岛素治疗6个月。观察并记录基线时和治疗3个月、6个月时患者的糖化血红蛋白（HbA_1c）、空腹血糖、餐后2 h血糖、空腹胰岛素、餐后2 h胰岛素、空腹C肽、餐后2 h C肽，以及体质量指数（BMI）、总胆固醇（TC）、三酰甘油（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）、肝脂肪变性情况用受控衰减参数（CAP）值表示]。结果 基线时两组患者的性别、年龄、BMI、HbA_1c、空腹血糖、餐后2 h血糖、空腹胰岛素、餐后2 h胰岛素、空腹C肽、餐后2 h C肽、TC、TG、HDL-C、LDL-C、CAP值、基础疾病和用药情况的差异均无统计学意义（P均>0.05）。治疗3个月、6个月时，两组患者HbA_1c、空腹血糖、餐后2 h血糖均较基线时下降（P均<0.01），但两组间差异均无统计学意义（P均>0.05）。在治疗3个月、6个月时，吡格列酮二甲双胍组空腹胰岛素、BMI、CAP值均低于基础胰岛素组（P<0.05、P<0.01）。经过6个月的治疗，吡格列酮二甲双胍组和基础胰岛素组血脂变化均不明显。结论 对于血糖控制不佳的超重或肥胖的2型糖尿病患者，加用吡格列酮二甲双胍能达到与基础胰岛素相似的降糖效果，但加用吡格列酮二甲双胍的患者在体质量、高胰岛素血症及肝脂肪变性方面改善更明显。

Pioglitazone-metformin and basal insulin on type 2 diabetes mellitus patients with overweight or obesity and poor blood glucose control: a comparison of efficacy and metabolic effects

Objective To compare the efficacy and metabolic effects of pioglitazone-metformin and basic insulin therapy on type 2 diabetes mellitus (T2DM) patients with overweight or obesity and poor blood glucose control. Methods A total of 153 T2DM patients with overweight or obesity and poor blood glucose control were enrolled in this study. They received treatment with pioglitazone-metformin (pioglitazone-metformin group, n=77) or insulin glargine (basal insulin group, n=76) for 6 months in addition to their previous oral hypoglycemic drugs. At baseline, 3 months and 6 months after treatment, glycosylated hemoglobin (HbA_1c), fasting blood glucose (FBG), 2 h post-prandial blood glucose (2hBG), fasting insulin (FINS), 2 h post-prandial insulin (2hINS), fasting C peptide (FCp), 2 h post-prandial C peptide (2hCp), body mass index (BMI), total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), and hepatic fatty degeneration (expressed as controlled attenuation parameterCAP] value) were observed and recorded. Results At baseline, there were no significant differences in gender, age, BMI, HbA_1c, FBG, 2hBG, FINS, 2hINS, FCp, 2hCp, TC, TG, HDL-C, LDL-C, CAP value, underlying diseases, or concomitant medicine between the two groups (all P>0.05). At 3 and 6 months after treatment, the HbA_1c, FBG and 2hBG levels were significantly decreased versus those at the baseline in the two groups (all P<0.01), but there were no significant differences between the two groups (all P>0.05). Compared with the basal insulin group, the FINS, BMI and CAP values were significantly decreased in the pioglitazone-metformin group 3 and 6 months after treatment (P<0.05, P<0.01). After 6 months of treatment, there were no significant changes of blood lipid levels in both groups. Conclusion In T2DM patients with overweight or obesity and poor blood glucose control, adding pioglitazone-metformin and basal insulin to their previous oral hypoglycemic drugs has similar hypoglycemic effect. However, patients receiving pioglitazone-metformin have better metabolic benefits such as lower BMI, lower insulin and improved hepatic fatty degeneration.