米格列醇联合二甲双胍与二甲双胍单药方案治疗2型糖尿病的效果和安全性比较  

Comparison of Efficacy and Safety of Miglitol Combined with Metformin Versus Metformin Monotherapy in Patients with Type 2 Diabetes Mellitus

作　　者：钟时嘉 ZHONG Shijia(Sichuan Provincial General Hospital of Judicial Police, Chengdu 610225, Chin)

机构地区：[1]四川省司法警官总医院,四川成都610225

出　　处：《中外医学研究》2018年第16期6-9,共4页CHINESE AND FOREIGN MEDICAL RESEARCH

摘　　要：目的:比较米格列醇联合二甲双胍与二甲双胍单药方案治疗2型糖尿病(T2DM)的效果和安全性。方法:选择笔者所在医院门诊新诊断的2型糖尿病患者72例,随机分为米格列醇联合二甲双胍治疗组(联合治疗组)和二甲双胍单药治疗组(单药治疗组),每组36例。联合治疗组给予米格列醇片和二甲双胍缓释片治疗,单药治疗组仅给予二甲双胍缓释片治疗。两组均连续用药12周。观察两组患者治疗前后空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、体重、体质指数(BMI)的变化情况和治疗过程中患者的不良反应,比较两组的疗效和安全性。结果:治疗后两组FBG、2 h PG、HbA1c、体重及BMI较治疗前均明显降低,差异有统计学意义(P<0.001);治疗后联合治疗组FBG、2 h PG及HbA1c较单药治疗组更低,两组差异有统计学意义(P<0.05),但两组间体重和BMI差异无统计学意义(P>0.05)。治疗后联合治疗组FBG、2 h PG、HbA1c、体重及BMI下降幅度较单药治疗组更大,两组间差异有统计学意义(P<0.001)。两组不良反应均表现为消化道症状,联合治疗组的不良反应发生率较单药治疗组高8.33%,但两组间不良反应发生率差异无统计学意义(P>0.05)。结论:米格列醇联合二甲双胍治疗比二甲双胍单药治疗对改善血糖水平、减轻体重的效果更好,且不良反应发生率无显著增加;对超重和肥胖的2型糖尿病患者,米格列醇联合二甲双胍治疗是一个合理的选项。Objective： To compare the efficacy and safety of miglitol combined with metformin versus metformin monotherapy in patients with type 2 diabetes mellitus（T2DM）. Method：A total of 72 newly diagnosed patients with T2DM were divided randomly into 2 groups,36 cases in each group.Patients in the combination therapy group were treated with miglitol and metformin,and those in the monotherapy group were treated only with metformin.All patients were treated for 12 weeks. Before and after treatment, fasting plasma glucose（FBG）,2-hour postprandial blood glucose（2 h PG）, glycated hemoglobin A1c（HbA1c）, body weight（BW） and body mass index（BMI） were measured, and adverse events（AEs） related to drugs were recorded.Result：After 12 weeks of treatment, the values of FBG, 2 h PG, HbA1c,BW and BMI decreased significantly in both groups,the difference was statistically significant（P〈0.001）.The values of FBG,2 h PG,HbA1c were less significantly in the combination therapy group than those in the monotherapy group,the difference was statistically significant（P〈0.05）,whereas BW and BMI were not significantly different between two groups（P〈0.05）.In the combination therapy group,the amount of variation in FBG,2 h PG,HbA1c,BW and BMI was greater than that in the monotherapy group, and there were significant differences between the groups（P〈0.001）.AEs manifested as gastrointestinal symptoms in both groups. Although the incidence of AEs was 8.33% more in the combination therapy group than in the monotherapy group,the difference was not significant（P〈0.05）.Conclusion：Compared to metformin monotherapy, miglitol combined with metformin is more effective in glycemic control and weight loss, and doesn＇t increase the incidence of AEs significantly.For overweight or obese patients with type 2 diabetes mellitus,combination therapy with miglitol and metformin is a reasonable option.

关 键 词：2型糖尿病 药物治疗 Α-糖苷酶抑制剂 肥胖 

分 类 号：R587.1[医药卫生—内分泌]