国产瑞格列奈治疗老年2型糖尿病的有效性和安全性研究

摘要

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≥0.75 mg)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 generic repaglinide in the treatment of elderly T2DM patients. Methods A total of 300 T2DM patients from 13 centers were enrolled in this multi-centric, open-labeled and self-controlled study. All of them were over 60 years old with T2DM duration of at least 3 months. The observation lasted for 12 weeks. The efficacy indicators included HbAi c, FPG, and 2hPG, and the safety parameters included hypoglycemia reaction, changes of renal and hepatic functions, serum lipids, blood and urinary profiles and other adverse events. Results Of the 300 patients, 291 followed throughout the study. After the 12-week treatment, their levels of HbAi c, FPG, and 2hPG decreased significantly (all P<0. 01). The reduction of HbAic FPG, and 2hPG in the repaglinide high dose group (the averaged dose for single use ≥ 0. 75 mg) was more than that in the repaglinide low dose group (all P<0. 01), without increased incidence of hypoglycemia The overall incidence of mild hypoglycemia was 4. 5%. Other serious adverse events were not present. Conclusion Repaglinide is an effective and safe drug in the treatment of elderly T2DM patients.