格列齐特缓释片治疗2型糖尿病的疗效及安全性  

Efficacy and safety of sustained-release gliclazide in the treatment of patients with type-2 diabetes mellitus

作　　者：顾明君[1] 刘颖[1] 刘春宏[1] 方瑾[1] 贺佳[2] 刘志民[1] 

机构地区：[1]第二军医大学长征医院内分泌科,上海200003 [2]第二军医大学卫勤系卫生统计学教研室,上海200433

出　　处：《药学服务与研究》2006年第1期38-41,共4页Pharmaceutical Care and Research

摘　　要：目的:比较口服格列齐特缓释片和普通片治疗2型糖尿病患者的疗效和安全性。方法:在随机、双盲、双模拟、平行对照临床试验中,72例2型糖尿病患者分为两组,格列齐特片组36例,80 mg/次,2次/d;格列齐特缓释片组36例,60mg/次,1次/d,疗程均为12周。结果:与基线值比较;格列齐特缓释片组中,HbA1c平均下降1.19%,空腹和餐后血糖值分别下降2.162、.06 mmol/L;而格列齐特片组中,HbA1c平均下降1.08%,空腹和餐后血糖值分别下降1.87、2.28 mmol/L。两组间空腹和餐后血糖水平下降率比较没有统计学差异。未见严重不良反应及实验室证实的低血糖(血糖≤2.78 mmol/L)。结论:格列齐特缓释片能有效改善2型糖尿病患者的全天血糖及HbA1c水平。Objective： To compare the clinical efficacy and safety of once dailyrregimen with oral sustained-release gliclazide and twice-daily regimen with oral gliclazide in the treatment of type 2 diabetic patients. Methods： Seventy-two type-2 diabetic patients were assigned to sustained-release gliclazide （60 rag, qd for 12 weeks） or gliclazide （80 rag, bid for 12 weeks） group in a randomized, double blind, double dummy trial. Results： Comparing with the baseline values, HbA1c, fasting and postprandial plasma glucose levels and 24-hour glucose profiles in the two groups were significantly reduced after 12-week treatment. In sustained-release gliclazide group, the mean reductions in blood HbA1c, fasting and postprandial plasma glucose levels were 1.19%, 2.16 mmol/L and 2.06 retool/L, respectively; in glielazide group, the mean reductions in blood HbA1c, fasting and postprandial plasma glucose levels were 1.08%, 1.87 mmol/L and 2.28 mmol/L, respectively. The differences in the responsive rate of reductions in fasting and postprandial plasma glucose levels between the two groups were not statistically significant. No serious adverse events in the two groups were found and no laboratory proved hypoglycemia （plasma glucoses≤2.78 mmol/L） was observed. Conclusion： Once-daily regimen with sustained-release gliclazide provides an effective control of 24-hour glucose profile for type-2 diabetic patients.

关 键 词：糖尿病 非胰岛素依赖性 格列齐特 迟效制剂 

分 类 号：R587.1[医药卫生—内分泌]