盐酸二甲双胍缓释片与普通片治疗2型糖尿病的有效性和安全性

Efficacy and safety of metformin hydrochloride sustained release tablets and common metformin hydrochloride tablets in treatment of type 2 diabetes mellitus

目的比较盐酸二甲双胍缓释片和盐酸二甲双胍普通片治疗2型糖尿病的有效性和安全性。方法选取2013年1月至2017年1月首都医科大学附属北京安贞医院收治的120例2型糖尿病患者,完全随机分为观察组和对照组,各60例。观察组口服盐酸二甲双胍缓释片1 500 mg/次,1次/d;对照组口服盐酸二甲双胍普通片500 mg/次,3次/d;2组均治疗3个月。通过血糖指标、治疗有效率、不良反应等评估药物作用效果。结果治疗后观察组和对照组患者空腹血糖、餐后2 h血糖、糖化血红蛋白水平均较治疗前明显降低[观察组:(5.30±0.21)mmol/L比(8.21±0.43)mmol/L、(6.7±1.0)mmol/L比(11.5±1.3)mmol/L、(6.0±1.2)%比(8.5±1.4)%,对照组:(5.31±0.22)mmol/L比(8.22±0.43)mmol/L、(6.7±1.0)mmol/L比(11.5±1.3)mmol/L、(6.1±1.2)%比(8.5±1.4)%](P<0.05),但组间比较差异无统计学意义(P>0.05)。观察组总有效率稍高于对照组[93.3%(56/60)比90.0%(54/60)],组间差异无统计学意义(P>0.05)。2组患者腹泻、上腹疼痛、恶心、消化不良的发生率比较,差异无统计学意义(P>0.05)。结论盐酸二甲双胍缓释片和普通片治疗2型糖尿病的有效性和安全性相当,但缓释片每日1次,服用方便,依从性更佳。

Objective To analyze the efficacy and safety of metformin hydrochloride sustained release tablets and common metformin hydrochloride tablets in treatment of type 2 diabetes mellitus. Methods Totally 120 patients with type 2 diabetes mellitus were enrolled from January 2013 to January 2017 in Beijing Anzhen Hospital, Capital Medical University; they were divided into observation group and control group, with 60 cases in each group. The observation group took metformin hydrochloride sustained release tablets 1 500 rag/time, 1 time/d; the control group took common metformin hydrochloride tablets 500 mg/time, 3 times/d; both groups were treated for 3 months. Blood glucose indexes, clinical efficiency and adverse reactions were analyzed. Results Fasting plasma glucose（FPG）, postprandial 2 h plasma g!ucose（2 h PG） and glycosylated hemoglobin（HbAlc） after treatment were significantly lower than those before treatment [ observation group ： （5.30 ± 0. 21 ） mmol/L vs （ 8.21 ± 0. 43 ） mmol/L, （6.7± 1.0） mmol/L vs （11.5 ± 1.3） mmol/L, （6.0 ± 1.2）% vs （8.5 ± 1.4）% ; control group： （5.31 ± 0. 22） mmot/L vs （ 8. 22± 0. 43 ） mmol/L, （ 6. 7 ± 1. 0） mmol/L vs （ 11.5± 1.3 ） mmol/L, （6. 1±1.2） % vs （ 8.5 ± 1.4） % ] （P 〈0. 05） ; there were no significant differences of FPG, 2 h PG and HbAlc between groups（P 〉0. 05）. The total effective rate in observation group was higher than that in control group[ 93. 3% （ 56/60 ） vs 90. 0% （54/60） ] （ P 〉 0. 05 ）. There was no significant differences of incidences of diarrhea, epigastric pain, vomiting and indigestion between groups（P 〉 0. 05 ）. Conclusion Mefformin hydrochloride sustained release tablets and common metformin hydrochloride tablets are both safe and effective in treatment of type 2 diabetes.