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中国临床药理学与治疗学 ›› 2010, Vol. 15 ›› Issue (7): 803-808.

• 临床药理学 • 上一篇    下一篇

二甲双胍格列吡嗪片治疗2型糖尿病的有效性及安全性的临床研究

姚璐1, 吕肖锋1, 纪欣1, 张建立2   

  1. 1北京军区总医院内分泌科,北京 100070;
    2北京四环科宝有限公司,北京 100203
  • 收稿日期:2010-03-12 修回日期:2010-06-05 出版日期:2010-07-26 发布日期:2020-09-15
  • 通讯作者: 吕肖锋,男,主任医师,硕士生导师,研究方向:糖尿病大血管并发症及骨质疏松症的发病机制。Tel: 010-66721166 E-mail: neifenmike@126.com
  • 作者简介:姚璐,女,硕士,主治医师,研究方向:糖尿病及大血管并发症。Tel: 13810148242 E-mail: luluheng@126.com

Clinical study on efficacy and security of fixed-dose glipizide/metformin on type 2 diabetes mellitus(DM)

YAO Lu1, LV Xiao-feng1, JI Xin1, ZHANG Jian-li2   

  1. 1Department of Endocrinology, General Hospital of Beijing Military Region,Beijing 100700,China;
    2Sihuankebao Medicine Compary,Beijing 100203,China
  • Received:2010-03-12 Revised:2010-06-05 Online:2010-07-26 Published:2020-09-15

摘要: 目的: 以格列吡嗪片和二甲双胍片为对照,评价二甲双胍格列吡嗪片治疗2型糖尿病的有效性和安全性。方法: 采用多中心、随机、双盲、三模拟、阳性药平行对照研究方法,用药观察周期为12周,其中试验组服用药物为二甲双胍格列吡嗪片+格列吡嗪模拟片+盐酸二甲双胍模拟片;格列吡嗪对照组服用药物为格列吡嗪片+二甲双胍格列吡嗪模拟片+盐酸二甲双胍片模拟片;盐酸二甲双胍对照组服用药物为盐酸二甲双胍片+格列吡嗪模拟片+二甲双胍格列吡嗪模拟片。结果: 随机化入组患者352例,其中二甲双胍格列吡嗪组116例、二甲双胍组118例、格列吡嗪组118例。经治疗12周后,二甲双胍格列吡嗪片组、二甲双胍片组、格列吡嗪片组糖化血红蛋白(HbA1c)分别为(5.5±1.3)%、(6.0±1.4)%、(6.1±1.5)%;空腹血糖分别为(7.3±1.8)、(7.9±2.3)、(8.2±2.4) mmol/L;餐后2小时血糖分别为(11.0±4.0)、(12.2±4.2)、(12.5±4.5) mmol/L,3项指标较用药前均有显著下降,各组疗后组间比较差异有统计学意义(P<0.05)。治疗后3组餐后2小时胰岛素均有所上升,空腹胰岛素无明显变化。二甲双胍格列吡嗪片、二甲双胍片两组甘油三酯有所下降,格列吡嗪片组有所升高,胆固醇前后差值组间比较无统计学意义。三组共发生不良事件54例,不良反应22例,三组比较无统计学差异。结论: 二甲双胍格列吡嗪片是一种安全有效的降糖药物。

关键词: 2型糖尿病, 二甲双胍, 格列吡嗪

Abstract: AIM: To evaluate the effect and safety of fixed-dose glipizide/metformintablets on type 2 diabetes. METHODS: This was a double blind randomized 12-week clinical observation on multiple centers comparing the blood glucose lowering effect and safety between fixed-dose glipizide/metformin tablets and glipizide co-administered with metformin.RESULTS: The cohort consisted of 116 patients who received glipizide/metformin tablets and 118 taking glipizide and 118 taking metformin. The levels of glycosylated hemoglobin (HbA1c)were (5.5±1.3)%,(6.0±1.4)% and (6.1±1.5)%,the levels of fasting blood glucose (FBG) were (7.3±1.8),(7.9±2.3) and (8.2±2.4)mmol/L and the levels of 2 hours postprandial blood glucose (PBG 2 h) were (11.0±4.0),(12.2±4.2) and (12.5±4.5)mmol/L, in glipizide/metformin group, metformin group, glipizide group, after 12-week therapy. The level of 2 hours postprandial insulin was increased,but the fasting insulin level was significantly changed. The levels of TG were decreased in glipizide/metformin and metformin groups,and that in the glipizide group was increased . There were no statistical difference of the rates of side effect in three groups.CONCLUSION: Fixed-dose glipizide/metformin is a convenient, effective and safe blood glucose lowering drug for diabetic patients.

Key words: Type 2 diabetes, Metformin, Glipizde

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