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目的:评价2型糖尿病单用二甲双胍(1.5g/日)血糖不达标者,联用津力达颗粒的临床疗效。方法:180例2型糖尿病患者参加了随机对照、多中心临床研究,患者被随机分配至试验组(津力达颗粒)或对照组(二甲双胍增量至2.0g/日),疗程12周。评价糖化血红蛋白、空腹血糖、餐后2小时血糖、HOMA胰岛素抵抗指数、β细胞功能指数、体重、腰围和体重指数。结果:在第12周,试验组糖化血红蛋白水平降低了0.96±0.99%,对照组降低了0.55±0.95%(P<0.05)。试验组空腹血糖、餐后2小时血糖、体重、腰围和体重指数分别下降了1.36、2.87、0.33、0.55和0.12,对照组为0.76、1.65、0.06、0.18和0.03,试验组β细胞功能指数升高了0.39,对照组升高了0.17,试验组的疗效优于对照组(P<0.05)。试验组的不良反应发生率(5.56%)明显低于对照组(14.44%)。结论:津力达颗粒可显著提高单用二甲双胍的降糖效果,进一步改善β细胞功能,津力达颗粒与二甲双胍联用有一定的临床价值。
OBJECTIVE: To evaluate the clinical efficacy of metformin in patients with type 2 diabetes mellitus (1.5g / day) who do not meet the standard of glycemic control. METHODS: One hundred and eighty patients with type 2 diabetes participated in a randomized controlled, multicenter clinical study. Patients were randomized to either the experimental group (julolidate) or to the control group (metformin in increments of 2.0 g / day) for 12 weeks. HbA1c, fasting blood glucose, 2-hour postprandial blood glucose, HOMA insulin resistance index, β-cell function index, body weight, waist circumference and body mass index were evaluated. Results: At week 12, the hemoglobin level of test group decreased by 0.96 ± 0.99% and that of control group by 0.55 ± 0.95% (P <0.05). Fasting blood glucose, postprandial blood glucose, body weight, waist circumference and body mass index decreased by 1.36, 2.87, 0.33, 0.55 and 0.12 respectively in the experimental group and 0.76, 1.65, 0.06, 0.18 and 0.03 in the control group. The beta cell function index 0.39 higher and 0.17 higher in the control group than in the control group (P <0.05). The incidence of adverse reactions in the experimental group (5.56%) was significantly lower than that in the control group (14.44%). CONCLUSION: Jinlida granules can significantly improve the antihyperglycemic effect of metformin alone and further improve the function of β-cells. The combination of Jinlida granules and metformin has certain clinical value.