摘要: 目的：深入研究采用达格列净联合二甲双胍的办法对新诊断超重及肥胖2型糖尿病患者进行治疗的临床实践效果。方法：将60例血糖控制不达标的2型糖尿病病人随机分为观察组(n = 30)与对照组(n = 30)，观察组在内分泌营养指导基础上采用达格列净联合二甲双胍治疗的办法进行针对性治疗，对照组在内分泌营养指导基础上采用单药二甲双胍治疗，观察期为3个月。比较两组治疗前后体质量、尿微量白蛋白、收缩压(systolic blood pressure, SBP)、舒张压(diastolic blood pressure, DBP)、糖化血红蛋白(glycosylated hemoglobin, HbA1c)、空腹血糖(fasting blood glucose, FBG)、餐后2 h血糖(postprandial blood glucose, PBG)、胰岛素抵抗指数(insulin resistance index, HOMA-IR)、胰岛β细胞功能指数(Insulin β cell function index, HOMA-β)、甘油三酯(triglyceride, TG)、总胆固醇(total cholesterol, TC)、高密度脂蛋白胆固醇(high-density lipoprotein cholesterol, HDL-C)、低密度脂蛋白胆固醇(low-density lipoprotein cholesterol, LDL-C)等指标变化。结果：观察组治疗后体质量、尿微量白蛋白、SBP、DBP水平较治疗前显著降低(t = 9.716, 9.134, 3.027, 2.29, P < 0.05)，对照组体质量水平较治疗前显著降低(t = 6.022, P < 0.001)，两组治疗前后体质量下降幅度差异有统计学意义(t = 3.708, P < 0.001)。观察组治疗后HbA1c、FBG、2hPBG水平较治疗前显著降低(t = 8.313, 9.813, 5.413, P < 0.001)，对照组治疗后HbA1c、FBG、2hPBG水平较治疗前显著降低(t = 4.072, 4.406, 3.625, P < 0.001)，两组治疗前后HbA1c、2hPBG下降幅度差异有统计学意义(t = 2.263, 2.674, P < 0.05)。观察组治疗后HOMA-IR、HOMA-β水平较治疗前显著改善(t = 3.889, −4.373, P < 0.001)，对照组治疗后HOMA-IR水平较治疗前显著改善(t = 3.889, P < 0.001)，两组治疗前后HOMA-β下降幅度差异有统计学意义(t = −4.282, P < 0.001)。观察组治疗后TG、TC、LDL水平较前显著降低(t = 8.895, 7.812, 2.193, P < 0.05)，HDL水平较治疗前显著上升(t = −2.044, P = 0.05)；对照组治疗后TG、TC水平较治疗前显著降低(t = 3.125, 6.886)，HDL、LDL水平较治疗前差异无统计学意义(t = 0.59, 0.716, P > 0.05)，两组治疗前后TG、TC水平下降幅度差异有统计学意义(P > 0.001)。以2hPBG < 10 mmol/L为血糖控制达标，两组达标率无统计学意义(P > 0.05)，以HbA1c < 6.5%、FBG < 7 mmol/L为血糖控制达标，两组达标率比较差异有显著性(t = 5.455, 6.239, P < 0.05)。两组患者治疗前后出现不良反应的概率比较差异无统计学意义(t = 4.278, P > 0.05)。结论：达格列净联合二甲双胍新诊能够降低超重及肥胖2型糖尿病病人血糖纠正水平，纠正糖脂代谢紊乱，改善胰岛素抵抗，提高HbA1c达标率，同时降低患者体重、血压及尿微量白蛋白水平，能够在心血管和肾脏方面获益，尚未发现增加不良反应的可能性。
Abstract:
Objective: To study the clinical practice effect of dapagliflozin combined with metformin in the treatment of newly diagnosed overweight and obese patients with type 2 diabetes mellitus. Methods: 60 patients with type 2 diabetes mellitus whose blood glucose control was not up to standard were randomly divided into an observation group (n = 30) and a control group (n = 30). The observation group was treated with dapagliflozin combined with metformin on the basis of endocrine nutrition guidance. The control group was treated with single-drug metformin on the basis of endocrine nutrition guidance, and the observation period was 3 months. The body weight, urine microalbumin, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), fasting blood glucose (FBG), 2 h postprandial blood glucose (PBG), Insulin resistance index (HOMA-IR), Islet β-Cell Function Index (HOMA-β), triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and other indicators changes. Results: After treatment, the body weight, urine microalbumin, SBP and DBP levels of the observation group were significantly lower than those before treatment (t = 9.716, 9.134, 3.027, 2.29, P < 0.05), and the body weight of the control group was significantly lower than those before treatment (t = 6.022, P < 0.001), and there was a statistically significant difference in weight loss between the two groups before and after treatment (t = 3.708, P < 0.001). After treatment, the levels of HbA1c, FBG and 2hPBG in the observation group were significantly lower than those before treatment (t = 8.313, 9.813, 5.413, P < 0.001), and the levels of HbA1c, FBG and 2hPBG in the control group were significantly lower than those before treatment (t = 4.072, 4.406, 3.625, P < 0.001), and there was a statistically significant difference in the decrease of HbA1c and 2hPBG between the two groups before and after treatment (t = 2.263, 2.674, P < 0.05). After treatment, the levels of HOMA-IR and HOMA-β in the observation group were significantly improved compared with those before treatment (t = 3.889, −4.373, P < 0.001), and the levels of HOMA-IR in the control group were significantly improved after treatment (t = 3.889, P < 0.001), and there was a statistically significant difference in the decrease of HOMA-β between the two groups before and after treatment (t = −4.282, P < 0.001). After treatment, the levels of TG, TC and LDL in the observation group were significantly decreased (t = 8.895, 7.812, 2.193, P < 0.05), and the level of HDL was significantly increased (t = −2.044, P = 0.05); the levels of TG and TC in the control group after treatment were significantly lower than those before treatment (t = 3.125, 6.886), while the levels of HDL and LDL were not significantly different from those before treatment (t = 0.59, 0.716, P > 0.05). TC levels decreased with statistical significance (P > 0.001). Taking 2hPBG < 10 mmol/L as the standard of blood sugar control, there was no statistical significance in the rate of reaching the standard between the two groups (P > 0.05), and taking HbA1c < 6.5% and FBG < 7 mmol/L as blood sugar control compliance, there was a significant difference in the compliance rate between the two groups (t = 5.455, 6.239, P < 0.05). There was no significant difference in the probability of adverse reactions between the two groups before and after treatment (t = 4.278, P > 0.05). Conclusion: Dapagliflozin combined with metformin newly diagnosed can reduce the blood sugar correction level of overweight and obese patients with type 2 diabetes, correct glucose and lipid metabolism disorders, improve insulin resistance, increase the rate of HbA1c compliance, and at the same time reduce the patient’s body weight, blood pressure and urine microalbumin levels. Cardiovascular and renal benefits have not been found to increase the possibility of adverse effects.