瑞格列奈联合二甲双胍治疗2型糖尿病的临床研究

Repaglinide in combination with metformin hydrochloride in the treatment of type 2 diabetes

目的观察复方制剂瑞格列奈二甲双胍片治疗2型糖尿病的临床效果。方法将292例经盐酸二甲双胍单药治疗无效的2型糖尿病患者随机分为对照组和试验组,每组146例。对照组给予瑞格列奈1 mg+盐酸二甲双胍500 mg联合用药,每天2次,口服给药。试验组给予瑞格列奈二甲双胍片复方制剂(1 mg/500 mg),每天2次,口服给药。2组患者经过2周的调整用药期,根据患者的空腹血糖值(fasting plasma glucose, FPG)进行调药,随后进入稳定治疗期。比较2组患者的糖化血红蛋白(glycated hemoglobin, HbA1c)、FPG、血脂和体重的变化。结果治疗后,试验组和对照组的HbA1c与基线相比分别降低了(1.40±1.15)%和(1.23±1.00)%,FPG比基线降低了(1.64±2.24)和(1.60±2.01) mmol·L-1,TC与基线相比分别变化了(0.04±0.72)和(0.01±0.82) mmol·L-1,TG与基线相比分别变化了(0.13±1.27)和(-0.20±1.61)mmol·L-1,体重分别下降了(0.27±1.80)和(0.3±1.75) kg,差异均无统计学意义(P>0.05)。治疗后,试验组和对照组的药物不良反应发生率分别为13.01%(19例/146例)和16.44%(24例/146例),差异无统计学意义(P>0.05)。结论复方制剂瑞格列奈二甲双胍片和瑞格列奈+盐酸二甲双胍片两种用药方式均可以有效且持久的控制血糖,药物不良反应的发生情况相似,在临床应用中的安全性和耐受性良好。

Objective To observe the clinical effect of compound repaglinide metformin tablets in the treatment of type 2 diabetes.Methods 292 patients with type 2 diabetes who failed to respond to metformin hydrochloride monotherapy were randomly divided into control group and treatment group, 146 patients in each group.The control group was given repaglinide 1 mg and metformin hydrochloride 500 mg, twice a day by oral administration.The treatment group was given compound repaglinide metformin(1 mg/500 mg) twice a day by oral administration.Two groups of patients after 2 weeks of drug adjustment, according to the fasting blood glucose value of patients to adjust drugs, and then entered the stable treatment period.The changes of glycosylated hemoglobin(HbA1c), fasting plasma glucose(FPG), blood lipid and body weight were compared between the two groups.Results After treatment, the glycosylated hemoglobin(HbA1c)of the treatment group and the control group decreased by [(1.40 ± 1.15) % vs(1.23 ± 1.00) %] respectively,the fasting plasma glucose(FPG) decreased by [(1.64 ± 2.24) vs(1.60 ± 2.01) mmol · L-1],the Total cholesterol(TC) have changed[(0.04 ± 0.72) vs(0.01 ± 0.82) mmol · L-1],the Triglyceride(TG) have changed [(0.13 ± 1.27) vs(-0.20 ± 1.61) mmol·L-1],and the weight decreased by [(0.27 ± 1.80) vs(0.3 ± 1.75) kg],compared with baseline,none of the above has statistically significant difference(all P > 0.05).After treatment,the incidence value of drug adverse reactions was 13.01%(19/146) and 16.44%(24/146),with no statistically significant difference(P > 0.05).Conclusion Both compound repaglinide metformin tablets and repaglinide + metformin hydrochloride tablets can effectively and persistently control blood glucose.Drug adverse reactions have similar situations,and are safe and well tolerated in clinical application.