天麦消渴片联合二甲双胍对新诊断2型糖尿病患者的疗效及安全性  

Efficacy and safety of Tianmaixiaoke tablet combined with metformin in patients with newly diagnosed type 2 diabetes mellitus

作　　者：梁凯[1] 武传龙[1] 张惠然[2] 井庆平 班博[4] 王旭光[5] 王美建[1] 侯新国[1] 陈丽[1] 

机构地区：[1]山东大学齐鲁医院内分泌科,济南250012 [2]威海市立医院内分泌科 [3]淄博市第一人民医院内分泌科 [4]济宁医学院附属医院内分泌科 [5]济宁市第一人民医院内分泌科

出　　处：《中华糖尿病杂志》2014年第9期650-654,共5页CHINESE JOURNAL OF DIABETES MELLITUS

基　　金：国家科技支撑计划（2009BAI80B04）;中华医学会临床医学科研专项基金（12030420342）

摘　　要：目的 评价天麦消渴片联合二甲双胍治疗新诊断2型糖尿病患者的疗效和安全性.方法 采用多中心、随机、平行对照、临床研究方法,选择2011年9月至2012年2月山东5家医院符合条件的新诊断2型糖尿病患者150例,其中男性83例,女性67例,年龄在33～71岁.采用随机数字表法分为2组,试验组给予天麦消渴片（2片,每日2次）联合二甲双胍治疗（500 mg,每日3次）;对照组给予二甲双胍单药治疗（500 mg,每日3次）.每组75例,均治疗12周.治疗前后测定糖化血红蛋白（HbA1c）、空腹血糖（FPG）、餐后2h血糖（2 hPG）、稳态模型胰岛素抵抗指数（HOMA-IR）等相关指标,记录低血糖事件及药物不良反应.组间比较采用独立样本t检验,同组治疗前后比较采用配对t检验,率的比较采用Х^2检验.结果 共有134例患者完成12周的治疗,其中试验组69例,对照组65例.（1） HbA1c：治疗后两组较基线时均明显降低,试验组HbA1c降低幅度比对照组更显著[（1.0±0.8）％比（0.7±0.6）％;t=-3.205,P＜0.05].治疗后试验组HbA1c达标率高于对照组[44.9％（31/69）比26.2％（17/65）;Х^2=5.131,P＜0.05].（2）血糖：试验组FPG降低幅度（2.7±1.4） mmol/L及2 hPG降低幅度（5.2±2.9）mmol/L均显著高于对照组（2.0±1.8、3.8±2.4） mmol/L;t=-2.675、-2.930,均P＜0.01.（3） HOMA-IR：试验组治疗后低于对照组[（2.7±0.8）比（3.2±0.8）;t=4.62,P＜0.05].（4）不良反应：治疗过程中两组均未发生低血糖事件,不良反应发生率差异无统计学意义.结论 天麦消渴片联合二甲双胍可以提高新诊断2型糖尿病患者HbA1c达标率,改善胰岛素抵抗,具有良好的安全性.Objective To evaluate the efficacy and safety of Tianmaixiaoke tablet combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus.Methods A total of 150 newly diagnosed type 2 diabetics including 83 men and 67 women aged 33-71 years were randomly assigned to two groups.Patients in combination treatment group received Tianmaixiaoke （2 tablet,bid） combined with metformin（500 mg,tid）,while patients in the control group received metformin（500 mg,tid） only,and then followed-up for 12 weeks.All patients were required to receive laboratory examination before and after treatment,including glycosyiated hemoglobin （HbA1c）,fasting plasma glucose （FPG）,2 h postprandial blood glucose （2 hPG）,and other related indicators as efficacy endpoints.Safety endpoints included adverse events and hypoglycemia.The independent samples t-test was used to test differences between two groups.A paired t test was used to test differences before and after treatment in the same group.Differences in ratio variables were tested by the Х^2 test.Results A total of 134 patients were included in the final analysis,including 65 in combination therapy group and 69 in control group.（1）HbA1c：After 12-week treatment,the reduction of HbA1c from baseline in combination therapy group was far more than in control group （（1.0±0.8） % vs （0.7±0.6）%; t =-3.205,P〈0.05）.The HbA 1 c compliance rate in combination therapy group was higher than control group（44.9% （31/69）,26.2% （17/65）,respectively,Х^2=5.131,P〈 0.05）.（2）Blood glucose：The level of FPG （2.7± 1.4） and 2 hPG （5.2±2.9） in the combination therapy group was significantly lower than those in the control group （2.0± 1.8,3.8±2.4,respectively,t=-2.675,-2.930,both P〈0.01）.（3）HOMA-IR：Compared with the control group,the HOMA-IR in the combination therapy group reduced more significantly （2.7 ±0.8 vs 3.2± 0.8,respectively,t=4.62,P〈 0.05）.There was no statistically significant difference between

关 键 词：糖尿病 2型 二甲双胍 天麦消渴片 血糖 

分 类 号：R587.1[医药卫生—内分泌]