缓释格列奇特强化治疗2型糖尿病前瞻性研究

Prospective investigation on intensive blood-glucose control of Gliclazide MR capsule in type 2 diabetes

目的:探讨2型糖尿病患者以缓释格列奇特为主强化降糖治疗与血管并发症的关系。方法:研究为ADVANCE一小部分,采用2×2析因随机对照试验,6周导入期降压治疗后,合格者随机分为强化治疗组与标准治疗组,定期测定HbA-IC,生化指标、血压、体重等,随访5年,收集血管并发症与一般事件。结果:(1)强化组2年后平均HbAIC为6.5%(降低1.7%),标准组为7.1%(降低0.6%),组间差距>1%,达标率分别为71.7%与36%,且此后持续达标。(2)强化组大血管与微血管并发症发生率为22.2%,而标准组为57.1%。(3)强化组5年后Cr、TC、LDL-C分别下降23.3%,10.9%及12.5%。结论:2型糖尿病缓释格列奇特强化降糖治疗有效、安全,且可减少血管并发症发生的危险36.9%。

Objective：Discuss the relationship between intensive blood-glucose control by treatment of Gliclazide MR capsule and vascular complications in type 2 diabetes.Methods：The study is a small part of ADVANCE.22 randomized controlled trials were adopted.After six weeks of run-in treatment by lower blood pressure,eligible individual were divided into intensive group and standard group.HbAIC,biochemical indices,blood pressure and body weight were regularly mensurated.After 5 years follow-up,vascular complications and general occurrences were collected.Results：（1）Two years later,average HbAlC was 6.5% in intensive group（reduced 1.7%）,and 7.1% in standard group（reduced 0.6%）.Margin between the two groups is〉1%.Reaching index rate are 71.7% and 36% respectively.（2）The rates of complication of macrovascular and microvascular is 22.2% in intensivegroup,and 57.1% in standard group.（3）Five years later,Cr、TC、LDL-C respectively reduced 23.3%、10.9%及12.5% in intensive group.Conclusions：Intensive treatment of Gliclazide MR capsule in type 2 diabetes is safety and efficiency.The risks of occurrence of vascular complication were reduced 36.9%.