格列齐特缓释剂治疗2型糖尿病患者的疗效和安全性评价  

The efficacy and safety of 30 mg slow-released-gliclazide in type 2 diabetes mellitus

作　　者：李光伟[1] 潘长玉[2] 高妍[3] 袁申元[4] 杨文英[1] 邢小燕[1] 田慧[2] 郭晓惠[3] 李红兵[4] 

机构地区：[1]卫生部中日友好医院内分泌科,北京100029 [2]解放军总医院内分泌科 [3]北京大学第一医院内分泌科 [4]首都医科大学附属北京同仁医院糖尿病科

出　　处：《中华内科杂志》2004年第7期510-514,共5页Chinese Journal of Internal Medicine

摘　　要：目的　评价服用格列齐特缓释片 (达美康缓释剂 30mg片剂 )治疗 12周后 ,对 2型糖尿病患者总体控制的有效性及安全性 ,并与普通剂型比较。方法　 15 9例 2型糖尿病患者随机分配到格列齐特缓释剂和普通剂型组进行治疗。治疗 12周后以血糖化血红蛋白 ,空腹血浆葡萄糖和胰岛素水平 ,评价服用格列齐特缓释片对 2型糖尿病的有效性。同时通过对不良事件、主要体征、心电图以及临床实验室指标的分析 ,评价 12周治疗对 2型糖尿病病人的安全性。结果　 12周治疗后 ,格列齐特缓释剂组和普通剂型组血糖化血红蛋白水平非常接近 ,组间差异无统计学意义 (P =0 6 6 ) ,可信区间很窄 (- 0 15 ;+0 2 4 % ) ,表明临床疗效相当。两组 2 4h血糖曲线下面积 ,血糖日均值和空腹血清胰岛素水平也相近。两组经血糖监测观察到低血糖发作次数无统计学差异。所有不良事件中 ,仅 3次为中度 ,其余均为轻度。无病人因不良事件退出研究。研究中无严重不良事件发生。结论　格列齐特缓释剂与普通剂型的疗效和安全性相似。ObjectiveTo evaluate the efficacy and safety profile of a slow -released-gliclazide (Diamicron MR) in type 2 diabetes patients. Methods159 patients with type 2 diabetes were parallelly assigned to a slow-released-gliclazide or gliclazide group in a randomized,open,multi-center phase Ⅲ study to compare the efficacy of slow-released-gliclazide and gliclazide on overall diabetes control through HbA1c and the adverse events including hypoglycemic episodes and change of vital signs,electrocardiogram and clinical laboratory parameters after a 12-week treatment period. ResultsNo statistically significant difference was found in HbA1c levels between the slow-released-gliclazide and the gliclazide group ( P =0.66) after 12 weeks of treatment. HbA1c levels in the slow-released-gliclazide group were extremely close to those in the gliclazide group after 12 weeks of treatment (95%CI -0.15;+0.24%). Furthermore,plasma glucose area under curve/24 hours,mean daily plasma glucose and fasting serum insulin levels between these two groups were also not statistically different,indicating that the efficacy of treatment was similar. The number of patients reported to experience at least one episode of hypoglycemia,which was confirmed by capillary or venous glucose assessment,but by no means severe,was similar in both the treatment groups. The main reason for the hypoglycemic episodes was related to good plasma glucose control. No adverse event led to withdrawal of the medication. Systolic and diastolic blood pressure,heart rate and body weight did not change during the study. There was also no noticeable change in electrocardiogram,lipid profile,and parameters in blood biochemistry and hematologic testing during the study. ConclusionSlow-released-gliclazide and gliclazide had a similar efficacy and safety profile.

关 键 词：格列齐特缓释剂 治疗 2型糖尿病 疗效 安全性 

分 类 号：R587.1[医药卫生—内分泌] R977.15[医药卫生—内科学]