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格列吡嗪盐酸二甲双胍片治疗2型糖尿病的多中心、随机、双盲双模拟临床研究 被引量:3

Multi-center,randomized,double-masked,double-mimic active-controlled clinical trial of glipizide/metformin hydrochloride tablets for patients with type 2 diabetes
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摘要 目的评价格列吡嗪盐酸二甲双胍片(降血糖药)的疗效及安全性。方法用多中心、随机、双盲双模拟临床研究,试验组120例,二甲双胍组、格列吡嗪片组各60例,治疗12周。结果治疗前后试验组较二甲双胍组HbAlc多降低了0.78%,较格列吡嗪组多降低了0.41%(P<0.001);治疗前后试验组较二甲双胍组空腹血糖多降低了0.97 mmol·L^(-1),较格列吡嗪组多降低了1.36 mmol·L^(-1)(P<0.001);低血糖发生率3组相似。结论格列吡嗪盐酸二甲双胍与单药治疗相比,降低HbAlc、空腹及餐后2 h血糖均更为明显,且耐受性很好。 Objective To assess effects and tolerance of glipizide/metformin hydrochloride combination tablets in patients with type 2 diabetes mellitus. Methods A muhieenter, double - masked, parallel - group, double - mimic active - controlled study was performed in 5 centers in China. One hundred twenty patients received glipizide/metformin hydrochloride tablets, 60 patients received glipizide or metformin respectively for 12weeks. Results Glipizide/metformin hydrochloride tablets controlled the HbAlc level more effectively than did either glipizide or metformin monotherapies ( mean treatment differences, in favor of glipizide/ metformin, of -0.41% and -0.78% , respectively,P 〈 0. 001 ). Glipizide/metformin hydrochloride tablets also reduced the fasting plasma glucose (FPG) more effectively than did either glipizide or metformin monotherapies (mean treatment differences, in favor of glipizide/metformin, of -1. 36 mmol · L^-1 and -0.97 mmol · L^-1, respectively, P 〈 0. 001 ). Treatments were well tolerated, with a similar low incidence of symptoms of hypoglycemia in every group . Conclusion Glipizide/metformin hydrochloride tablets were more effective than either glipizide or metformin monotherapy in treating type 2 diabetes and had well tolerance.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2008年第5期387-391,共5页 The Chinese Journal of Clinical Pharmacology
关键词 2型糖尿病 格列毗嗪盐酸二甲双胍片 格列吡嗪 二甲双胍 type 2 diabetes mellitus glipizide/metformin hydrochloride tablets glipizide metformin
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