甘精胰岛素联合预混胰岛素疗法与预混胰岛素对长病程T2DM患者的疗效比较

目的比较甘精＋预混胰岛素早餐前联合注射方案与2次／d预混胰岛素治疗对长病程2型糖尿病（T，DM）患者的疗效及安全性。方法将256例门冬胰岛素30治疗后血糖控制不良的T2DM患者单中心随机并连续纳入观察组（128例，原门冬胰岛素30zk甘精胰岛素早餐前同时注射）与对照组（128例，在原方案基础上调整剂量）。各组均予阿卡波糖片及二甲双胍片口服。同时根据血糖调整各组胰岛素用量。26周后比较两组的空腹血糖（FBG）、三餐后2h血糖（2hPG）、糖化血红蛋白（HbA1C）及其达标率、体重指数（BMI）、日胰岛素剂量、低血糖事件。结果与基线时比较，观察组及对照组治疗后的FBG、三餐2hPG、HbA1C均下降，HbA1C迭标率提高（P均〈0．05）。治疗后对照组日胰岛素剂量及BMI增加（P均〈0．05），而观察组无改变。与对照组比较，观察组的FBG、早午餐2hPG、HbA1C、日胰岛素剂量、低血糖事件均更低，NHbA1C达标率更高（P均〈0．05）。两组晚餐2hPG无显著差异（P〉0．05）。结论对于早晚餐前门冬胰岛素30注射但血糖欠佳的长病程T2DM患者，改为早餐前甘精＋门冬胰岛素30联合注射能有效改善患者血糖谱和HbA1C，且晚餐2hPG未受明显影响，低血糖风险更小，而其注射模式也更方便。

Objective To compare the efficacy and safety between glargine combined with premixed insulin before breakfast and twice-daily premixed insulin in T2DM patients with long disease course under the premise of using acarbose for both therapies. Methods A total of 256 T2DM patients with poor blood glucose control after insulin aspart 30 therapy were single-center randomized and continuously brought into experimental group （ 128 patients, insulin aspart 30 and insulin glargine before breakfast were injected simultaneously ） and control group （ 128 patients, insulin dosage was adjusted on the basis of original regimen ） . The patients in the two groups were taken acarbose and metformin tablets, meanwhile, insulin dosage was adjusted according to PG. After 26 weeks, FBG, 2hPG after meals, HbA1C and its compliance rate, BMI, daily insulin dosage and hypoglycemia of the two groups were compared. Results Compared with the baseline, FBG, 2hPG after three meals and HbA1C in the experimental group and the control group decreased, compliance rate of HbA1C of the two groups increased （P〈0.05 for both groups ） . After treatment, daaly insulin dosage and BMI in the control group increased （ P〈0.05 for both ） , but those in the experimental group did not change. Compared with the control group, FBG, 2hPG after breakfast and lunch, HbA1C, daily insulin dosage and hypoglycemia of the experimental group were much lower, but compliance rate of HbA1C was higher （P〈0.05 for both groups ） . There was no significant difference between the two groups in 2hPG after dinner （P〉0.05） . Conclusion For long-course T2DM patients with poor blood glucose control after insulin aspart 30 injection before breakfast and dinner, glargine plus insulin aspart 30 injection can improved their blood glucose profile and HbA1C, besides, 2hPG after dinner is not affected significantly, risk of hypoglycemia is lower, and its injection mode is more convenient.