中国门诊2型糖尿病患者口服药降糖达标状况调查及格列齐特缓释片优化治疗效果分析

The glycemic control in Chinese type 2 diabetic out-patients receiving oral antidiabetic agents and the efficacy and safety of optimized modified-release gliclazide treatment

目的评估中国门诊2型糖尿病患者口服药降糖达标的现状，评价格列齐特缓释片[达美康缓释片，施维雅（天津）制药有限公司]一天一次的优化降糖方案的疗效及安全性。方法在全国20多个城市的54家医院通过义诊调查门诊口服药治疗（3个月以上）的2型糖尿病患者，评估HbA1c≤6．5％的达标率；对未达标患者人组优化治疗，即采用一天一次的格列齐特缓释片治疗替换每日多次服用的促分泌药物（磺脲类或格列奈类药物），治疗3个月后评价其临床疗效及安全性。结果血糖控制现状调查显示，5586名2型糖尿病患者的HbA。为（7．97±2．89）％，达标率为14．1％。1721例未达标的患者进行优化治疗后，HbA1c从优化前（8．23±4．00）％降为（6．86±2．24）％，平均值下降1．37％（P〈0．001），达标率提高为34．1％；空腹血糖从（8．87±4．65）mmoWL下降为（7．13±5．82）mmo]／L；餐后2h血糖从（12．50±4．00）mmo]／L下降为（8．96±3．61）mmol／L；仅有2．6％的患者报告可疑低血糖发生。结论目前中国门诊口服药治疗的2型糖尿病患者的血糖控制达标率较低；采用每日一次的格列齐特缓释片优化治疗方案，能安全有效地降低血糖，提高HbA1c达标率，对于优化2型糖尿病的管理有重要意义。

Objective To evaluate the current state of glycemic control in Chinese patients with type 2 diabetes mellitus who have received oral antidiabetic agents in the out-patient clinic,and the efficacy and safety of optimized regiments of gliclazide modified-release tablets （ Diamicron MR, SERVIER, Tianjin） in patients with failed glycemic control （ HbA1c 〉 6.5% ）. Methods The patients with type 2 diabetes were enrolled from 54 hospitals in more than 20 cities and received long-term （more than 3 months） oral antidiabetic agents. HbA1c was measured and the success rate of HbA1c reduction was evaluated. The patients who failed to achieve glyeemic control （HbA1c〉6. 5% ） and received daily multiple-dosing insulin secretagogues were provided with the optimized treatment regimen, consisting of replacing daily multiple-dosing insulin secretagogues with single-dosing gliclazide sustained-release tablets. Clinical efficacy and safety were evaluated after three months treatment. Results The survey of glycemic control revealed that the mean HbA,： of 5 586 patients with diabetes mellitus was （7.97± 2.89） % ,and the success rate （HbA1c ≤6. 5% ） was 14. 1%. Further more, HbA1c ： decreased from （8.23 ± 4.00） % before optimization to （6.86±2.24）% after optimization with the average decrement of 1.37% （P〈 0.001 ） and the success rate was raised to 34. 1%. The gliclazide modified-release tablets were well tolerated by most patients, only 2. 6% of whom were reported to experience unconfirmed hypoglycemia. Conclusion The success rate of glycemic control was low in Chinese out-patients with type 2 diabetes mellitus receiving oral antidiabetie agents in the clinic. The optimized regimen of glielazide modified-release tablets taken once daily can down-regulate glycemic levels and increase the success rate of HbA1c reduction, and thus plays efficiently and safely a key role in the optimized management of type 2 diabetes mellitus.