摘要
目的 :观察胰岛素联合多种口服降糖药治疗血糖控制仍未达标的2型糖尿病患者加用达格列净的疗效。方法:采用随机、单盲、安慰剂对照前瞻性研究。60例胰岛素联合2种或以上不同作用机制的口服降糖药治疗血糖未达标的2型糖尿病患者随机分为达格列净组与安慰剂组各30例,达格列净组加用达格列净10 mg/d,疗程12周。检测2组干预前后的平均空腹血糖、平均餐后2 h血糖、24 h葡萄糖曲线下面积、血糖变异系数、高血糖百分比和低血糖百分比、糖化血红蛋白、空腹和餐后2 h C肽、血酮、血尿酸、血脂、血压、体重和每日胰岛素剂量,同时监测24 h尿糖、蛋白、尿酸的定量,每周1次定期查尿常规,严密观察不良事件。结果:干预前2组各项基线指标相近(P>0.05)。治疗结束后安慰剂组各项指标较干预前均无明显改变(均P>0.05)。达格列净组治疗后平均餐后2 h血糖、24 h葡萄糖曲线下面积、血糖变异系数、高血糖百分比分别下降(4.6±1.8)mmol/L、(341±112)mmol/L、3.2±0.9、54.7%±19.8%,明显低于安慰剂组(均P<0.01);平均空腹血糖、糖化血红蛋白、三酰甘油、血尿酸与每日胰岛素剂量则下降(1.3±0.9)mmol/L、1.4%±0.9%、(0.3±0.5)mmol/L、(30±10)μmol/L、(8±6)U/d,且低于安慰剂组(均P<0.05);总胆固醇下降(0.4±0.7)mmol/L(P<0.05),但与安慰剂比较差异无统计学意义;24 h尿糖和尿酸排泄分别增加(37.8±9.9)g、(128±92)mg/24 h,高于安慰剂组(分别P<0.01和<0.05)。结论 :达格列净可以明显降低胰岛素联合多种口服降糖药治疗未达标的2型糖尿病患者的血糖,并降低血糖的波动,未明显增加低血糖等不良反应。
Objective To investigate the effect of dapagliflozin on type 2 diabetes mellitus with inadquate glycemic control after treatment with insulin combined with several oral hypoglycemic drugs. Methods In this randomized, singleblind, placebo controlled study, 60 patients with type 2 diabetes mellitus having not reached the glycemic targets after treatment with insulin combined with two or more oral hypoglycemic drugs were randomly divided into two groups. Thirty patients in the dapagliflozin group received additionally dapagliflozin 10 mg/d with a course of 12 weeks, while the other 30 patients were served as controls receiving additionally the placebo. Before and after intervention, 72-hour dynamic blood glucose monitoring was performed. Levels of average fasting blood glucose（FBG）, average 2 h postprandial blood glucose（2hBG）, 24 h area under the curve（AUC） of glucose, the glycemic coefficient of variation（CV）, percentage of time with high blood glucose and percentage of time with low blood glucose, glycosylated hemoglobin A1 c（Hb A1 c）, fasting and2 h postprandial serum C-peptide, blood ketone, serum uric acid（UA）, serum lipid, daily insulin dose, blood pressure,body weight, 24 h uric glucose, protein, UA were detected before and after treatment. Results There were no significant differences in baseline characteristics between the two groups（P〉0.05）. After 12 weeks treatment, the levels of average 2hBG, 24 h AUC of glucose, glycemic CV, percentage time of high blood glucose（all P〈0.01）, average FBG, Hb A1 c, serum TG, UA, daily insulin dose（all P〈0.05） were decreased and 24 h uric UA（P〈0.05）, 24 h uric glucose were increased（P〈0.01）in dapagliflozin group; no obvious changes were observed in placebo group（all P〉0.05）. No serious adverse reaction was observed in dapagliflozin group. Conclusions Dapagliflozin may improve glycemic control and decrease the blood glucose fluctuation without major hypoglycemic episodes.
作者
方文军
李晓永
冯绮文
简蔚霞
苏青
FANG Wenjun;LI Xiaoyong;FENG Qiwen;JIAN Weixia;SU Qing(Department of Endocrinology,Xinhua Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China)
出处
《内科理论与实践》
2018年第3期153-157,共5页
Journal of Internal Medicine Concepts & Practice
关键词
达格列净
胰岛素
2型糖尿病
Dapagliflozin
Insulin
Type 2 diabetes mellitus
