控释格列吡嗪与格列齐特治疗中国2型糖尿病患者的疗效比较  

Comparison of efficacy between Glipizide GITS and Gliclazide in the treatment of Chinese patients with type 2 diabetes mellitus

作　　者：潘长玉[1] 高妍[2] 李光伟[3] 王姮[4] 姚军[2] 田慧[1] 杨文英[3] 付勇[4] 邢小燕[3] 杜锦[1] 陆菊明[1] 马晓伟[2] 

机构地区：[1]中国人民解放军总医院内分泌科,北京100853 [2]北京大学第一临床医院内分泌科 [3]中日友好医院内分泌科 [4]北京协和医院内分泌科

出　　处：《中华内分泌代谢杂志》2001年第3期139-143,共5页Chinese Journal of Endocrinology and Metabolism

摘　　要：目的　评价每日 1次服用控释格列吡嗪 (商品名瑞易宁 )是否与一日 2～ 3次服用格列齐特 (达美康 )具有相同的降血糖效果。方法　从 4个临床中心征集符合WHO(1985年 )诊断标准的中国 2型糖尿病患者共 15 1例 ,分至控释格列吡嗪组 (78例 )或格列齐特组 (73例 )进行治疗和比较。结果　经过 1周清洗期 ,6周剂量调整期 ,6周剂量维持期后的结果显示 :与基线期相比较 ,控释格列吡嗪组与格列齐特组患者的糖化血红蛋白水平 (HbA1c) ,空腹血糖水平 (FPG)及全天血糖谱水平均有显著下降 ,控释格列吡嗪组HbA1c下降 0 .5 5 % ,FPG下降 2 .0 5mmol/L(P均 <0 .0 0 1) ;格列齐特组HbA1c下降 0 .47% ,FPG下降 2 .13mmol/L(P均 <0 .0 1) ,组间比较差异无显著性 (P >0 .0 5 )。两组不良事件的发生率相似 ,未见实验室检查证实的低血糖 (≤ 2 .78mmol/L) ,治疗前后的血脂水平及肝肾功能均无显著变化。结论　对于中国 2型糖尿病患者 ,每日一次服用控释格列吡嗪即可有效控制全天血糖水平 ,与每日多次服药的格列齐特疗效相同 。Objective To compare the clinical efficacy of once daily regimen with Glipizide GITS (Glucotrol XL) and multiple dose regimen with Gliclazide (Diamicron) in the treatment of Chinese patients with type 2 diabetes mellitus. Methods One hundred and fifty one Chinese type 2 diabetic patients meeting the 1985 WHO diagnostic criteria were recruited from 4 clinical centers. The patients were assigned to Glipizide GITS (78 cases) or Gliclazide (73 cases) treatment group. Results The trial consisted of 1 week washout period followed by 6 week dosage regulation period and 6 week dosage maintenance period. Comparing to the baseline, HbA 1c , fasting plasma glucose (FPG) and 24 hour glucose profile levels in two groups were significantly reduced after 3 month treatment. In Glipizide GITS group, the mean reductions of blood HbA 1c and FPG level were 0.55% and 2.05 mmol/L respectively (P<0.001); in Gliclazide group, the mean reductions of blood HbA 1c and FPG level were 0.47% and 2.13 mmol/L respectively (P<0.01). The differences in reductions of HbA 1c and FPG level between the two groups were not statistically significant. The incidence of adverse events in two groups was similar, nolaboratoryprovedhypoglycemia(plasmaglucose≤2.78 mmol/L) was observed. Hepatic function, renal function and lipid profile did not significantly change after treatment. Conclusion Once daily regimen with Glipizide GITS provides an effective 24 hour control of plasma glucose levels for Chinese patients with type 2 diabetes. Compared to multiple dosage regimen of Gliclazide, Glipizide GITS is equally well safe and effective.

关 键 词：Ⅱ型糖尿病 格列吡嗪 格列齐特 迟效制剂 缓释剂 药物治疗 

分 类 号：R587.1[医药卫生—内分泌] R977.15[医药卫生—内科学]