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格列齐特对糖尿病微血管病变的影响——多中心3年前瞻性研究
Effects of Gliclazide on diabetic microvascular complications in type 2 diabetic patients:a 3-year multicentral prospective study
【摘要】 目的 在 2型糖尿病的治疗中 ,评价格列齐特 (商品名达美康 )是否能有效地防止微血管病变的进展。方法 7个中心为期 3年的随机对照前瞻性研究。 2 85例 2型糖尿病分成格列齐特和格列本脲两个治疗组 ,调整降糖药用量、定期监测空腹及餐后 2小时血糖以及糖基化血红蛋白至控制目标。每年检查眼底及尿微量白蛋白排量。结果 初访时两组患者的平均年龄、性别、糖尿病病程、血糖控制水平、血压、视网膜病变程度及尿微量白蛋白排量差异均无显著性 ,3年治疗中 ,两组的血糖控制及血压水平亦无差异。 3年末格列齐特治疗组视网膜病变进展 1期有 4例 (2 .5 8% ) ,格列本脲治疗组有 2 4例 (18.46 % ) ,差异具有显著性 (P <0 .0 0 0 1)。多因素Logistic逐步回归分析显示格列齐特治疗与视网膜病变进展 1期呈独立负相关关系 (P =0 .0 0 0 1)。利用相同的分析模式 ,3年末格列齐特治疗与尿微量白蛋白排量增加≥ 2 0 μg/min状态也呈独立负相关关系 (P =0 .0 0 96 )。 结论 在本研究人群 ,格列齐特治疗 3年防止视网膜病变进展 1期和尿微量白蛋白轻度进展的作用稍优于格列本脲
【Abstract】 Objective To determine whether treatment with Gliclazide (Diamicron) is able to prevent development of microvascular complications in type 2 diabetes mellitus. Methods This trial was carried out in seven centers of the National Diabetes Mellitus Collaborative Study Group. Two hundred and eighty five patients with type 2 diabetes mellitus were recruited from six areas of China and divided into Gliclazide group (n=155) and Glibenclamide group (n=130). Age, sex, duration of diabetes and body mass index were recorded at entry. Fasting and 2h postprandial blood glucose were measured monthly while HbA 1c was determined at 3 month interval. Retinal photography and fluorescein angiography were performed in the 1st and 3rd year.Results There were no significant differences in age, sex, blood pressure, duration of diabetes, mean blood glucose and HbA 1c between the Gliclazide and Glibenclamide groups at baseline, in the 2nd and 3rd follow up year. There were no significant differences in retinopathy between the two groups at baseline, but at the end of the 3rd year, the subjects in Gliclazide group with retinopathy progression over one grade were significantly less than those in Glibenclamide group (2.58% vs 18.46%, P<0.0001). Logistic stepwise regression analysis showed that treatment with Gliclazide had an independently negative correlation with development of retinopathy. The same analysis procedure showed that treatment with Gliclazide had an independently negative correlation with the slight increase (≥20 μg/min) of urine microalbumin excretion. Conclusion Gliclazide shows a specific effects on retarding the progression of retinopathy and the slight development of urine microalbumin, which is independent of age, duration of diabetes, control tightness of blood glucose and blood pressure.
【Key words】 Diabetes mellitus, non insulin dependent; Gliclazide; Diabetic retinopathy;
- 【文献出处】 中华内分泌代谢杂志 ,Chinese Journal of Endocrinology and Metabolism , 编辑部邮箱 ,2001年03期
- 【分类号】R587.1
- 【被引频次】29
- 【下载频次】302