贝那鲁肽治疗2型糖尿病患者的疗效和安全性及给药方式研究

Study on the efficacy,safety and administration of benaluptide in the treatment of patients with type 2 diabetes mellitus

目的对比贝那鲁肽和磺脲类药物治疗2型糖尿病的疗效和安全性,并对持续皮下注射贝那鲁肽进行探索性分析。方法选取2017年6月至2020年6月在北京医院就诊的单用二甲双胍或以二甲双胍为基础的二联口服药物治疗血糖控制不佳的2型糖尿病患者60例为研究对象(除外二肽基肽酶4抑制剂、磺脲类或非磺脲类促泌剂),30例加用贝那鲁肽(包括餐前皮下注射20例和持续皮下给药10例),30例加用磺脲类药物(格列喹酮或格列美脲或格列齐特缓释片),分析治疗前后两组糖化血红蛋白(HbA1c)、空腹血糖(FPG)、体重较基线的变化,并做两组间HbA1c达标率(HbA1c<7%)、FPG和体重变化的比较,以及低血糖、胃肠道反应发生率的比较。结果治疗12周后两组HbA1c、FPG较基线均有显著下降(均P<0.001),贝那鲁肽组体重较基线显著下降(P<0.001),磺脲组体重无显著性变化(P=0.520)。贝那鲁肽组与磺脲组HbA1c达标率无显著差异(χ^(2)=0.703,P=0.796)。贝那鲁肽组低血糖发生率显著低于磺脲组(χ^(2)=4.453,P=0.035),胃肠道不良反应显著高于磺脲组(χ^(2)=15.709,P<0.001)。持续皮下注射贝那鲁肽较常规皮下注射胃肠道不良反应的发生率低(P<0.05)。结论对于二甲双胍控制不佳的2型糖尿病患者,联合贝那鲁肽及磺脲类药物均有明显降糖疗效,贝那鲁肽较磺脲类药物低血糖发生率低,有明显的减重效果,但胃肠道反应发生率更高。持续皮下注射贝那鲁肽具有可行性,并可减少胃肠道反应发生率。

Objective To compare the efficacy and safety of benaluptide and sulfonylureas in the treatment of type 2 diabetes,and to explore the continuous subcutaneous injection of benaluptide.Methods Sixty patients with type 2 diabetes who had poor blood glucose control(treated with metformin alone or metformin-based dual oral medication)from June 2017 to June 2020 in Beijing Hospital were selected.Patients treated with dipeptidyl peptidase 4 inhibitors and sulfonylureas or non-sulfonylureas meglitinide were excluded.Among them,30 patients were treated with benaglutide(including 20 cases of pre meal subcutaneous injection and 10 cases of continuous subcutaneous injection),and the other 30 patients were treated with sulfonylureas(gliquidone or glimepiride or gliclazide sustained-release tablets).The changes in the two groups of glycosylated hemoglobin(HbA1c),fasting plasma glucose(FPG),and body weight from baseline were analyzed.The HbA1c compliance(HbA1c<7%)rate,changes of FPG and weight,as well as the incidence of hypoglycemia and gastrointestinal side effects between the two groups were compared.Results After 12 weeks of treatment,HbA1c and FPG decreased significantly compared with baseline in both groups(all P<0.001).The body weight of the benaglutide group was significantly lower than that in the baseline(P<0.001),and the body weight of the sulfonylurea group had no significant change(P=0.520).There was no significant difference in HbA1c compliance rate(HbA1c<7%)between the two groups(χ^(2)=0.703,P=0.796).The incidence of hypoglycemia in the benaglutide group was significantly lower than that in the sulfonylurea group(χ^(2)=4.453,P=0.035),and the gastrointestinal side effects were significantly higher than those in the sulfonylurea group(χ^(2)=15.709,P<0.001).Continuous subcutaneous injection of benaglutide by insulin pump had a lower incidence of gastrointestinal reactions than conventional subcutaneous injection(P<0.05).Conclusions Benaglutide and sulfonylureas have a good treatment effect on patients with type 2 diabetes who are poorly controlled by metformin.Benaglutide has a lower incidence of hypoglycemia than sulfonylureas,and has a significant weight loss effect,but the incidence of gastrointestinal side effects is higher.Subcutaneous injection of benaglutide with insulin pump is feasible and can reduce the incidence of gastrointestinal side effects.