利拉鲁肽联合门冬胰岛素30治疗难治性2型糖尿病的临床疗效及安全性评价

Clinical efficacy and safety of liraglutide combined with insulin aspart 30 injection in the treatment of refractory type 2 diabetes mellitus

目的评价利拉鲁肽联合门冬胰岛素30治疗难治性2型糖尿病的临床疗效及安全性。方法将78例2型糖尿病患者随机分为对照组38例和试验组40例。2组患者均予以门冬胰岛素30联合口服降糖药。对照组予以地特胰岛素皮下注射,睡前1次,起始剂量0.2 U·kg-1·d-1;试验组予以利拉鲁肽皮下注射,睡前1次,起始剂量0.6 mg·d-1,1周后剂量为1.2 mg·d-1。2组患者均治疗16周。比较2组患者血糖控制的总有效率、胰岛素抵抗指数及胰岛素使用剂量、体重改变与低血糖发生率。结果治疗后,2组患者的空腹血糖、餐后2 h血糖、糖化血红蛋白及日间胰岛素使用量均较治疗前显著下降(均P<0.01)。治疗后,2组患者在控制血糖的总有效率上差异无统计学意义(P>0.05),但试验组的空腹C肽、餐后2 h血糖及胰岛素抵抗指数均明显低于对照组(P<0.05),体重显著下降(P<0.01),日间胰岛素使用量明显减少(P<0.05),低血糖发生率显著下降(P<0.05)。结论利拉鲁肽联合门冬胰岛素30治疗难治性2型糖尿病的临床疗效确切,不良反应少,较地特胰岛素有更多的获益。

Objective To evaluate the efficacy and safety of liraglutide（ Lira） combined with insulin aspart 30 injection in the treatment of type 2diabetes poorly controlled with premixed insulin aspart 30（ Asp 30）.Methods Seventy eight patients with type 2 diabetes mellitus without reaching glycemic targets were randomized into two groups. On the basis of the insulin aspart 30 and oral hypoglycemic drugs,the patients in the trial group were given liraglutide 0. 6 mg·d^- 1sc once per night for the first week,and 1. 2 mg · d^- 1for the following two to sixteen weeks,while the other patients in the control group received insulin detemir（ Det） sc once a night for 16 weeks,with the beginning dosage of 0. 2U·kg- 1·d^- 1. Before and after the treatment,the body mass index（ BMI）,waist to hip ratio（ WHR）,fasting plasma glucose（ FPG）,fasting C- peptide（ FCP）, 2- hour postprandial plasma glucose（ PPG 2 h）,glycosylated hemoglobin A1c（ Hb A1c） and insulin resistance index（ HOMA- IR） were tested. Also,the adverse drug reactions such as weight gain and hypoglycemia reaction were estimated.Results After the treatment,the level of FPG,PPG 2 h and Hb A1 c decreased obviously in both groups（ P〈 0. 01）,while PPG 2 h in thetrial group appeared a better improvement compared to the control group（ P〈0. 05）,and BMI as well as HOMA- IR was improved significantly in the trial group after the treatment（ P 〈0. 01）. Both drugs were well tolerated with minor hypoglycemia,yet Lira appeared much safer than Det. Conclusion For treatment of refractory type 2 diabetes mellitus,liraglutide combined with insulin aspart 30 injection had certain clincal efficacy with minor adverse reaction.