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目的评价国产瑞格列奈治疗老年T2DM的有效性和安全性。方法多中心、开放性、自身对照研究,入选13个中心300例血糖控制不佳、病程>3个月、年龄>60岁的T2DM患者,用国产瑞格列奈治疗12周,观察其有效性和安全性。结果完成研究291例,瑞格列奈治疗12周后的HbA1c、FPG和2hPG均比治疗前降低(P均<0.01);大剂量(平均单次剂量≥0.75mg)治疗组的HbA1c、FPG和2hPG下降幅度大于小剂量组(P均<0.01),低血糖发生率未有增加;总体均轻度低血糖反应,发生率4.5%,未见其他严重不良事件。结论瑞格列奈是老年T2DM患者安全有效的降血糖药物。
Objective To evaluate the efficacy and safety of domestic repaglinide in the treatment of T2DM in the elderly. Methods A multicenter, open-label and self-controlled study of 300 T2DM patients with poorly controlled glycemic control of more than 3 months and age> 60 years in 13 centers was treated with domestic repaglinide for 12 weeks and its efficacy And safety. Results After completing the study, HbA1c, FPG and 2hPG in 291 patients treated with repaglinide for 12 weeks were lower than those before treatment (all P <0.01); HbA1c, FPG and FPG in high dose (mean single dose ≥0.75mg) 2hPG decreased more than the low dose group (P <0.01), the incidence of hypoglycemia did not increase; the overall mild hypoglycemia, the incidence rate of 4.5%, no other serious adverse events. Conclusion Repaglinide is a safe and effective hypoglycemic agent in elderly patients with T2DM.