精蛋白锌重组赖脯胰岛素混合注射液(50R)治疗2型糖尿病60例

Efficacy of mixed protamine zinc recombinant human insulin lispro injection(50R) in 60 patients with type 2 diabetes mellitus

目的:研究精蛋白锌重组赖脯胰岛素混合注射液(50R)(优泌乐50,LM50)治疗2型糖尿病的临床疗效。方法:选择门诊与病房60例口服降糖药控制不佳的2型糖尿病患者,先进行为期10 d的优泌灵70/30导入期治疗。然后随机将患者分成A,B两组,A组改用优泌乐50,B组继续应用优泌灵70/30,每隔3 d监测血糖谱,并根据血糖调整胰岛素用量。两组患者肥胖者均使用二甲双胍,不用胰岛素促泌剂及其他口服降糖药物。治疗12周后,采用交叉研究,A,B两组互换治疗方案,胰岛素总量等量互换,口服二甲双胍不变,观察并比较12周和24周后两组空腹血糖(FBG),早餐后2 h血糖(2 h-PBG,早),晚餐后2 h的血糖(2 h-PBG,晚),糖化血红蛋白(HbA1C),发生可察觉的低血糖的次数,以及胰岛素总量等各项指标的变化,从而比较两组治疗效果。结果:A,B两组在血糖总体的控制上无显著性差异,即两组治疗后HbA1C比较无显著性差异,但在餐后血糖的控制以及低血糖的发生率上优泌乐50与优泌灵70/30有显著性差异。提示优泌乐50控制餐后2 h血糖效果更好,低血糖发生率更低。结论:优泌乐50治疗2型糖尿病疗效肯定,对餐后血糖的控制与优泌灵70/30比较存在优势,且低血糖发生率低。

Objective：To evaluate the efficacy of mixed protamine zinc recombinant human insulin lispro injection（50R）（lispro mix 50/50,LM 50） in patients with type 2 diabetes mellitus.Methods：Outpatients and inpatients（n=60） with type 2 diabetes,who were poorly controlled by oral hypoglycemic agents,were enrolled.After advanced behavior period of 10 days with Humulin 70/30,they were randomly divided into two groups,and treated with either LM 50 or Humulin 70/30.At intervals of 3 days,blood glucose spectrum was monitored,and insulin dose was adjusted according to blood glucose.Patients with obesity took metformin additionally but not took other insulin secretion-promoting oral hypoglycemic drugs.After treatment for 12 weeks,a cross-over study was performed,namely the dose regimens were exchanged each other in two groups,with equal insulin amounts and same oral metformin treatment.At 12 and 24 weeks,the following indicators were observed and compared： fasting blood glucose（FBG）,plasma glucose 2 h after breakfast（2h-PBG,early）,blood glucose 2 h after dinner（2h-PBG,evening）,glycosylated hemoglobin（HbA1C）,the incidence of perceived hypoglycemia,the total amount of insulin and other indicator changes.Results：The controls of the overall blood glucose were not significantly different in two groups,that is,levels of HbA1C were similar in two groups.However,the control of postprandial blood glucose and the incidence of hypoglycemia were significantly more effective in LM 50 group than in Humulin 70/30 group.Conclusion：LM 50 is effective in treatment of type 2 diabetes,especially in controlling postprandial blood glucose,and the incidence of hypoglycemia is lower as compared to Humulin 70/30.