| Background:Progressingly decrease of B-cell function is the base of the occurrence and development of diabetes,while the sustained blood glucose is the main reason to cause and increase B-cell failure. Good glycemic control can significantly reduce and delay complications of diabetes,so it is important to apply short term of intensive insulin therapy on type 1 or 2 diabetic to correct high blood glucose as soon as possible. We compared and analyzed efficacy and safety of the lispro and Novolin R used in intensive insulin treatment of type 1 or type 2 diabetic patients.Objective:After 12 weeks'intensive insulin treatment on patints with type 1 and type 2 diabetes,compare the clinical efficacy and safety of lispro and Novolin R,and evaluate the safety of lispro product.Methods:After screening 50 cases of patients with type 1 or type 2 diabetes, we hold this randomized,opened and parallel cotrolled clinical study,which inclues three period:screening period of 1-2 weeks,intaking period of 2 weeks and treatment period of 12 weeks having seven follow-ups. During the intaking period, we corrected glycemia with qwer ih 30 minutes before each meal plus 1 injection of NPH ih 22:00 every night. The patients whose condition still met the selected subjects after two weeks'screening period would received the lispro or human insulin R intensive treatment,and two drugs are used before every meal (3/day) in subcutaneous injection(lispro;5min before every meal;novolin R 30 min) with the application of intermediate-acting insulin before going to bed for 12 weeks.The insulin dosage was provided and adjusted according to the actual situation of patients.All the patients volunteered for the experiment and signed informed consent before the experiment.Compared HbAlc, FBQP1BG, P2BG and BMI of the same group before and after the treatment, and compared the mentioned index and the incidence of hypoglycemia between two groups after the experiment.SPSS16.0 software was used for statistical analysis. before-after analysis of the same group were compared by paired t-test; inter-group analysis were compare by two-sample t-test;continuous variables are reported as mean±standard deviation(x±s), a p value less than 0.05 is considered significant.Results:A total of 50 patiets were enrolled,30 patients for lispro group and 20 patients for novolin R group.47 cases (28 cases of lispro groupand 19 of cases nonolin R group) completed of the experiment. treatment of 12 weeks,HbAlc in lispro group and novolin R group decreased by 1.74% and 1.75% (both p<0.001).P1hBG decreased by 4.90 mmol/L (lispro group, P<0.001) and 4.75 mmol/L (novolin R group, P<0.001).P2hBG decreased by 4.97mmol/L (lispro group, P<0.001) and 4.46mmol/L (novolin R group,p<0.001).All index previously mentioned in two groups had no significant difference between the two group.The incidence of hypoglycemia was 23.3% (lispro group 7/30)和35.0% (novolin R group 7/20), and the chi-square value was 5.223, (P=0.022), suggesting that the incidence occurred in lispro group was significantly lower than novolin R group's. Body mass index in the lispro group significantly increased(P<0.05), but didn't increase significantly in the novolin R group(P=0.872), while the comparison between the two groups, this increase was no significant difference.Conclusion:HbA1c,P1hBG and P2hBG of the lispro group and novolin R group were significantly improved, the comparison of these indicators between these two groups had no significant differences. This suggests that these two kinds of insulin in the intensive insulin treatment were both effective significantly, but the comparison between them had no significant difference. BMI of lispro group increased significantly, but had no significance in the novolin R group, and the comparison between the two groups had no significant difference.The incidence of hypoglycemia in the lispro group was lower than in the novolin R group,suggesting that in the intensive insulin treatment lispro was safet than novolin R. |
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