·糖尿病临床研究·

　　浙江省瑞格列奈临床观察协作组

　　作者单位：协作组成员：浙江大学医学院附属邵逸夫医院(李红、周嘉强);浙江大学医学院附属第一医院(李成江);浙江省人民医院(华燕吟);浙江省中医院(倪海祥);杭州市第一人民医院(张楚);宁波市第一人民医院(钮雁文);宁波市李惠利医院(马丽娜、张广吾);温州医学院附属第一医院(汪大望);金华中心医院(胡素银);衢州市人民医院(胡朝晖、祝素文);丽水市人民医院(陈日秋);台州中心医院(王超);台州第一人民医院(王丽君)

　　通信作者：李红，E-mail：lihongheyi@126.com

　　【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。

　　【关键词】瑞格列奈;糖尿病, 2型;老年;血糖

　　doi:10.3969/j.issn.1006-6187.2012.04.015

　　Clinical evaluation of efficacy and safety of generic repaglinide in the treatment of elderly T2DM patientsRepaglinide Clinical Study Collaboration Group of Zhejiang Province

　　Corresponding author: LI Hong,E-mail:lihongheyi@126.com

　　【Abstract】ObjectiveTo evaluate the efficacy and safety of generic repaglinide in the treatment of elderly T2DM patients.MethodsA 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 HbA1c, 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.ResultsOf the 300 patients, 291 followed throughout the study. After the 12-week treatment, their levels of HbA1c, FPG, and 2hPG decreased significantly (all P<0.01). The reduction of HbA1c, 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.ConclusionRepaglinide is an effective and safe drug in the treatment of elderly T2DM patients.

　　【Key words】Repaglinide; Diabetes mellitus, type2;Elderly; Plasma glucose