一种口服降糖药治疗血糖控制不佳的2型糖尿病患者加用基础胰岛素或第二种口服降糖药的疗效和安全性 ; Efficacy and safety of additional basal insulin or oral antidiabetic drug in type 2 diabetes poorly controlled with one oral antidiabetic drug

目的 比较一种口服降糖药治疗后血糖控制不佳的2型糖尿病患者加用甘精胰岛素或第二种口服降糖药的疗效和安全性.方法 2006年6月至2007年12月从全国12个研究中心入选387例接受一种口服降糖药(双胍类或磺脲类药物)治疗但血糖控制不佳的2型糖尿病患者(糖化血红蛋白7.5％ ～11.0％,空腹血糖＞7.5 mmol/L),平均年龄54岁.采用随机表法(1∶1)将其分为加用甘精胰岛素组(n=193,起始剂量为10 U/d)和加用另一种口服降糖药组(n=194,加用磺脲类或双胍类药物,按产品说明书用药),治疗24周.调整2组用药剂量,使空腹血糖达到并维持在≤5.6 mmol/L.测定0及24周时糖化血红蛋白、标准餐试验空腹及餐后2h血糖、C肽水平.采用t检验或卡方检验进行数据统计.结果 共有375例患者(男184例,女191例)纳入最终分析,其中加用甘精胰岛素组186例,加用另一种口服降糖药组189例.治疗24周后,2组糖化血红蛋白较基线时显著下降,但2组糖化血红蛋白下降值的差异无统计学意义[分别为(1.5±1.3)％和(1.3±1.3)％,Z=-1.3914,P=0.1641].进一步亚组分析结果显示,加用甘精胰岛素组中胰岛素剂量＞0.2U·kg-1 ·d-1的亚组(n=114)24周时糖化血红蛋白较基线的下降幅度大于加用另一种口服降糖药组[分别为(1.6±1.2)％和(1.3±1.3)％,Z=-1.9962,P=0.0459].加用甘精胰岛素组空腹血糖及餐后2h血糖降低幅度均优于加用另一种口服降糖药组(Z=- 5.5516、- 3.9158,均P＜0.01).空腹及餐后2hC肽水平变化2组间差异有统计学意义(Z=- 5.3894、- 2.7775,均P＜0.01).2组低血糖事件发生率无明显差异.结论 在一种口服降糖药治疗后血糖控制不佳的2型糖尿病患者中加用甘精胰岛素治疗或增加第二种口服降糖药均能有效控制血糖,但前者充分调整剂量后降糖效果优于后者. ; Objective To compare the efficacy and safety of insulin glargine vs additional oral antidiabetic drug (OAD) combined with one basic OAD in patients with poorly controlled type 2 diabetes mellitus (T2DM). Methods A total of 387 patients (mean age 54 years ) with T2DM who were inadequately controlled with one kind of sulfonylureas (SU) or metformin for at least 3 months were eligible for enrollment from 12 centres of China from June 2006 to December 2007.All the patients were randomized to receive insulin glargine (Group A,n =193 ) or an additional OAD (Group B,n =194) for 24 weeks.The changes in glycated haemoglobin (HbA1c) level,blood glucose parameters,and C-peptide level and incidence of hypoglycemia were assessed and compared between the two groups at 24 weeks.Student' s t test was used for data analysis. Results A total of 375 patients were included in the final analysis ( 186 in Group A and 189 in Group B).After 24-week treatment,the reduction of HbA1c from baseline was 1.5％ in Group A and 1.3％ in Group B (t =-7802.0,-6983.5,both P＜0.01),and the reduction was comparable between the two groups (Z =- 1.3914,P =0.1641 ).The reduction of HbAlc from baseline to 24 weeks in the subgroup of ...