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目的探讨新诊断T2DM患者胰岛素强化治疗后艾塞那肽或预混胰岛素序贯治疗的临床疗效和安全性比较。方法选取2014年1月至2015年12月于我院住院的新诊断T2DM患者132例,随机分为3组,入院后予胰岛素强化治疗,血糖控制平稳后予艾塞那肽联合甘精胰岛素治疗(艾塞那肽+甘精胰岛素组,n=48),艾塞那肽联合二甲双胍治疗(艾塞那肽+二甲双胍组,n=32)及预混胰岛素治疗(预混胰岛素组,n=52)。观察12周,比较治疗前后FPG、2hPG、HbA_1c、FC-P、BMI、胰岛素抵抗指数(HOMA-IR)、胰岛β细胞分泌指数(HOMA-β)及低血糖和消化道不良反应发生率。结果治疗12周后各组FPG、HbA_1c和HOMA-IR较治疗前降低(P<0.05),HOMA-β较治疗前升高[(42.28±29.10)vs(117.05±64.39),(39.81±21.52)vs(116.00±56.28),(44.25±31.80)vs(112.79±41.78),P<0.05],治疗后各组间比较,差异无统计学意义(F=0.502、0.315、1.620、0.062、0.271,P>0.05);治疗后预混胰岛素组体重、BMI高于艾塞那肽+甘精胰岛素组和艾塞那肽+二甲双胍组(F=3.246、11.449,P<0.05);艾塞那肽+二甲双胍组低血糖发生率低于预混胰岛素组(3.13%vs 21.15%)(χ~2=5.258,P<0.05);预混胰岛素组消化道不良反应发生率低于艾塞那肽+甘精胰岛素组和艾塞那肽+二甲双胍组[(0.00%vs 20.83%),(0.00%vs 25.00%)],(χ~2=12.037、14.368,P<0.01)。结论新诊断T2DM患者胰岛素强化治疗后选择艾塞那肽联合二甲双胍或基础胰岛素治疗,其降糖效果不劣于预混胰岛素,但体重控制更佳,低血糖发生率更低。
Objective To investigate the clinical efficacy and safety of sequential treatment of exenatide or premixed insulin after intensive insulin therapy in newly diagnosed T2DM patients. Methods A total of 132 newly diagnosed T2DM patients hospitalized in our hospital from January 2014 to December 2015 were randomly divided into three groups. After admission, patients were given intensive insulin therapy. Exenatide combined with insulin glargine (Exenatide + insulin glargine group, n = 48), exenatide plus metformin (exenatide + metformin group, n = 32) and premixed insulin therapy ). The levels of FPG, 2hPG, HbA 1c, FC-P, BMI, HOMA-IR, HOMA-β and hypoglycemia and gastrointestinal adverse reactions were observed before and 12 weeks after treatment. Results After 12 weeks of treatment, the levels of FPG, HbA 1c and HOMA-IR in each group were significantly lower than those before treatment (P <0.05). HOMA-β was significantly higher than that before treatment [(42.28 ± 29.10) vs (117.05 ± 64.39), (39.81 ± 21.52) (116.00 ± 56.28), (44.25 ± 31.80) vs (112.79 ± 41.78, P <0.05]. There was no significant difference between the two groups after treatment (F = 0.502,0.315,1.620,0.062,0.271, P > 0.05). The body weight, BMI of premixed insulin group were higher than that of exenatide + insulin glargine group and exenatide + metformin group (F = 3.246, 11.449, P <0.05) The incidence of hypoglycemia in the pre-mixed insulin group was lower than that in the premixed insulin group (3.13% vs 21.15%, χ ~ 2 = 5.258, P <0.05). The incidence of adverse gastrointestinal reactions in the premixed insulin group was lower than that of exenatide plus insulin glargine Group ([(0.00% vs 20.83%), (0.00% vs 25.00%)], (χ ~ 2 = 12.037, 14.368, P <0.01) with exenatide plus metformin. Conclusions Exenatide combined with metformin or basal insulin after intensive insulin therapy in patients with newly diagnosed T2DM, the hypoglycemic effect is not inferior to premixed insulin, but weight control is better and the incidence of hypoglycemia is lower.