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目的评估利格列汀联合胰岛素治疗2型糖尿病(type 2 diabetes mellitus,T2DM)合并肾病患者有效性和安全性。方法 60例患者,随机分为胰岛素联合利格列汀组(利格列汀组)和对照组(胰岛素联合安慰剂),治疗12周,观察治疗前后患者体质量、血糖、肾功能、尿微量白蛋白(microalbuminuria,M-Alb)定量、C肽水平、胰岛素用量的变化;同时记录两种治疗方案的不良事件,评估治疗方案的安全性。结果两种治疗方案均可有效降低患者空腹血糖(fasting blood glucose,FBG)、餐后2 h血糖(2-hour plasma glucose,2hPG)、糖化血红蛋白(glycosylated hemoglobin,HbA1c),两组治疗前后M-Alb、肌酐清除率(creatinine clearance rate,Ccr)无明显差异(P>0.05),利格列汀组胰岛素用量小于对照组,组间比较差异具有统计学意义(P<0.05)。结论两种治疗方法均能有效控制血糖,且均不加重肾脏损害,但胰岛素联合利格列汀能更好地减少胰岛素用量、控制体质量、减少低血糖风险。
Objective To evaluate the efficacy and safety of linagliptin combined with insulin in the treatment of type 2 diabetes mellitus (T2DM) with nephropathy. Methods Sixty patients were randomly divided into two groups: insulin combined with linagliptin (linagliptin) and control (insulin combined with placebo) for 12 weeks. Before and after treatment, the body weight, blood glucose, renal function, urine microalbuminuria Albumin (microalbuminuria, M-Alb), C-peptide level and insulin dosage. Meanwhile, the adverse events of the two treatment regimens were recorded and the safety of the treatment regimen was evaluated. Results Both treatment regimens could effectively reduce fasting blood glucose (FBG), 2-hour plasma glucose (2hPG) and glycosylated hemoglobin (HbA1c) in both groups before and after treatment, Alb, creatinine clearance rate (Ccr) had no significant difference (P> 0.05), and the dosage of insulin in linagliptin group was less than that of control group. The differences between the two groups were statistically significant (P <0.05). Conclusion Both treatment methods can effectively control blood sugar, and did not aggravate renal damage, but insulin combined with linagliptin can reduce insulin dosage, control body weight and reduce the risk of hypoglycemia.