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中国临床药理学与治疗学 ›› 2009, Vol. 14 ›› Issue (2): 175-179.

• 临床药理学 • 上一篇    下一篇

米格列奈钙片治疗2型糖尿病的安全性及有效性的临床研究

吕肖锋1, 姚璐1, 朱旅云2, 刘俊江3, 柴建国4, 张善飞4   

  1. 1北京军区总医院内分泌科, 北京100070;
    2中国人民解放军白求恩国际和平医院内分泌科, 石家庄050082, 河北;
    3河北省人民医院内分泌科, 石家庄050051, 河北;
    4正大青春宝药业有限公司, 杭州310023, 浙江
  • 收稿日期:2008-08-01 修回日期:2008-12-05 出版日期:2009-02-26 发布日期:2020-10-30
  • 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:分子生物学。Tel:13810148242  E-mail:luluheng @126.com

Clinical study on efficacy and safety of mitiglinide on type 2 diabetes mellitus

LV Xiao-feng1, YAO Lu1, ZHU Lv-yun2, LIU Jun-jiang3, CHAI Jian-guo4, ZGANG Shan-fei4   

  1. 1Department of Endocrinology, General Hospital of Beijing Military Region, Beijing 100700, China;
    2Department of Endocrinology, BAI Qiu-en Peace Hospital, Shijiazhuang 050082, Hebei, China;
    3Department of Endocrinology, Hebei General Hospital, Shijiazhuang 050051, Hebei, China;
    4Zhengdaqingchunbao Medicine Company, Hangzhou 310023, Zhejiang, China
  • Received:2008-08-01 Revised:2008-12-05 Online:2009-02-26 Published:2020-10-30

摘要: 目的:通过与进口那格列奈比较评价国产米格列奈钙片治疗2 型糖尿病的安全性及有效性。方法:选择2 型糖尿病患者218 例, 用双盲双模拟随机平行方法分组, 治疗16 周后比较两组餐后2h 静脉血糖、糖化血红蛋白及静脉和指尖空腹血糖。检测不良事件及不良反应发生率, 血压、心率、血、尿常规、肝肾功能、心电图作为安全性评价指标。结果:治疗后两组餐后2 h 血糖、糖化血红蛋白、静脉空腹血糖和指尖空腹血糖较治疗前均有显著下降, 两组间疗效无统计学差异。两组不良事件和不良反应发生率及对血压、心率、血尿常规、肝肾功能及心电图的影响均无统计学差异。结论:国产米格列奈片治疗2 型糖尿病疗效确切,安全性和耐受性良好。

关键词: 糖尿病, 米格列奈钙片, 有效性, 安全性

Abstract: AIM: To evaluate the efficacy and safety of domestic mitiglinide and imported nateglinide. METHODS: The study was designed in double blind and double simulation fashion.218 patients of type 2 DM were randomly treated with either mitiglinide or nateglinide.The treatment course was 16 weeks.Before the treatment and after 16 weeks of the treatment, the blood glucose of 2 hours after meal, HbA1C, fasting plasma glucose in vein and FBG were detected as the efficient index.The adverse event, adverse reaction incident, blood pressure, heart rate, blood and urine routine, function of Liver and Kindey, ECG were detected as the safety index.RESULTS: Blood glucose of 2 hours after meal, HbA1C, fasting plasma glucose in vein and FBG were decreased in both groups after treatment, efficacy, adverse event, adverse reaction incident, blood press, heart rate, blood and urine routine, function of Liver and Kindey, ECG were no distinct difference between mitiglinide and nateglinide P 0.05.CONCLUSION: The curative effect of domestic mitiglinide is exact, efficacy and the tolerance is favourable.

Key words: diabetes mellitus, mitiglinide, efficacy, security

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