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

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 the both groups in HOMA-β index （t=-2.337,P〉 0.05）.（4） Adverse reaction：There was not statistically significant difference between the two groups in the incidence of adverse reactions.Conclusion Tianmaixiaoke tablet combined with metformin may increase the HbA1c compliance rate,improve insulin resistance,and has a good safety in the treatment of newly diagnosed type 2 diabetic mellitus.