利拉鲁肽注射液联合精蛋白锌重组赖脯胰岛素混合注射液(50R)治疗肥胖型2型糖尿病患者的临床研究

Clinical trial of liraglutide injection combined with mixed protamine zinc recombinant human insulin lispro injection(50R)in the treatment of patients with obese type 2 diabetes

目的观察利拉鲁肽注射液联合精蛋白锌重组赖脯胰岛素混合注射液(50R)治疗肥胖型2型糖尿病(T2DM)患者的临床疗效及安全性。方法将98例单纯降糖药治疗效果不佳的肥胖型T2DM患者随机分为对照组和试验组,每组49例。对照组给予精蛋白锌重组赖脯胰岛素混合注射液(50R)每次30 U,bid,餐前皮下注射+二甲双胍每次0.5 g,tid,口服;试验组给予精蛋白锌重组赖脯胰岛素混合注射液(50R)每次30 U,bid,餐前皮下注射+利拉鲁肽第1个月以每次1.2 mg,qd,皮下注射,后改为每次1.8 mg,qd,皮下注射。2组患者均治疗4个月。比较2组患者的空腹血糖(FPG)、糖化血红蛋白(HbA1c)和胰岛素抵抗指数(HOMA-IR),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的FPG分别为(5.81±1.40)和(7.03±1.52)mmol·L^-1,HbA1c分别为(5.32±0.68)%和(6.81±0.90)%,HOMA-IR分别为(3.20±0.82)和(4.67±0.85),差异均有统计学意义(P<0.05)。2组患者的药物不良反应均以注射部位轻度疼痛和胃肠道不适为主。试验组和对照组的总药物不良反应发生率分别为12.24%和8.16%,差异无统计学意义(P>0.05)。讨论利拉鲁肽注射液联合精蛋白锌重组赖脯胰岛素混合注射液(50R)治疗肥胖型T2DM患者的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of liraglutide injection combined with mixed protamine zinc recombinant human insulin lispro injection(50R)in the treatment of patients with obese type 2 diabetes(T2DM).Methods A total of 98 obese T2DM patients with poor treatment effects of simple hypoglycemic drugs were randomly divided into control and treatment groups with 49 cases per group.Control group was given mixed protamine zinc recombinant human insulin lispro injection(50R)30 U per time,tid,subcutaneous injection before meal+metformin 0.5 g,bid,orally.Treatment group received mixed protamine zinc recombinant human insulin lispro injection(50R)30 U per time,bid,subcutaneous injection before meal+liraglutide 1.2 mg per time,qd,subcutaneous injection in the first month,and then changed to subcutaneous injection at 1.8 mg per time,qd,subcutaneous injection.Two groups were treated for 4 months.The fasting plasma glucose(FPG),glycated hemoglobin(HbA1c),Homeostasis model assessment-insulin resistance(HOMA-IR)and adverse drug reactions were compared between two groups.Results After treatment,the main indexes of treatment and control groups were compared:FPG were(5.81±1.40)and(7.03±1.52)mmol·L^-1,HbA1c were(5.32±0.68)% and(6.81±0.90)%,HOMA-IR were(3.20±0.82)and(4.67±0.85),the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were mild pain at the injection site and gastrointestinal discomfort.The incidences of total adverse drug reactions in the treatment and control groups were 12.24% and 8.16% without statistically significant difference(P>0.05).Conclusion Liraglutide injection combined with mixed protamine zinc recombinant human insulin lispro injection(50R)has a definitive clinical efficacy in the treatment of obese T2DM patients,without increasing the incidence of adverse drug reactions.