摘要
目的评价国产格列齐特缓释片治疗2型糖尿病(T2DM)的疗效和安全性。方法234例T2DM患者随机分为两组:对照组117例,口服格列齐特片,每次80 mg,每日2次;试验组117例,口服格列齐特缓释片,每次60 mg,每日1次。疗程12周。结果225例完成了试验。两组均可有效降低空腹血糖(FBG)、餐后2 h血糖(2 hBG)和糖化血红蛋白(HbA1c),差异无统计学意义。格列齐特缓释片组降低FBG的显效率与总有效率分别为51.26%和93.16%,格列齐特片组的显效率与总有效率分别为44.44%与94.02%。格列齐特缓释片组降低2 hBG的显效率与总有效率分别为29.91%和92.31%,格列齐特片组的显效率与总有效率分别为23.08%与89.74%。两组不良反应发生率均为7.69%。未见严重不良反应及实验室证实的低血糖(血糖≤2.78 mmol/L),个别病例谷丙转氨酶轻度升高。结论国产格列齐特缓释片能有效地降低FBG、2 hBG以及HbA1c水平。患者耐受性好,不良反应轻微。
Objective To compare the clinical efficacy and safety of once-daily 60 mg of slow- released gliclazide （China Associate Pharmaceutical Co. LTD） with twice-daily of gliclazide （160 mg/d） in the treatment of Chinese patients with type 2 diabetes mellitus（T2DM）. Methods 234 Chinese patients with T2DM meeting 1997 WHO diagnostic criteria were recruited from 4 clinical centers. The patients were assigned to slow-released gliclazide （117 case） or gliclazide （117 cases） treatment group in a ramdomized, double blinded, muhicentre clinical trial. The trial consisted of 2- weeks wash followed by 12-week treatment period. Results Compared with the baseline, HbA1c, fasting and postprandial plasma glucose levels were significantly reduced in two groups after 12-week treatment. In slow-released gliclazide group,the mean reductions of blood HbA1c, fasting and postprandial plasma glucose levels were 0.81%, 1.91 mmol/L and 2.41mmol/L respectively;in gliclazide group, the mean reductions of blood HbAlc, fasting and postprandial plasma glucose levels were 0.76% ,1.97mmol/L and 2.13 mmol/L respectively. The differences in the reduction rates of fasting and postprandial plasma glucose levels between the two groups were not statistically significant. No serious adverse events in two groups were found; no laboratory-proved hypoglycemia （plasma glucose ≤2.78 mmol/L） was observed. Conclusion Once-daily 60 mg of slow-released gliclazide provides an effective control of plasma glucose levels for Chinese T2DM patients. Compared with twice-daily of gliclazide （160 mg/day）, slow-released gliclazide is equally well safe and effective.
关键词
糖尿病
2型
格列齐特
缓释制剂
Diabetes mellitus, type 2
Gliclazide, sustained-release preparation
作者简介
协作组成员：200003上海，第二军医大学长征医院内分泌科（刘志民、顾明君、刘颖）；天津医科大学总医院内分泌科（冯凭、郑宝忠、高志红）；复旦大学附属华山医院内分泌科（沈稚舟、单玉明、胡吉）；复旦大学附属中山医院内分泌科（高鑫、余丹菁、殳雪怡）；第二军医大学卫生统计教研室（贺佳、陆健、虞慧婷）
