甘精胰岛素与门冬胰岛素对比中性鱼精蛋白锌胰岛素和普通胰岛素治疗1型糖尿病患儿的随机临床试验

A Randomized Clinical Trial of Insulin Glargine and Aspart, Compared to NPH and Regular Insulin in Children with Type 1 Diabetes Mellitus.

作者信息

Rostami Parastoo, Setoodeh Aria, Rabbani Ali, Nakhaei-Moghadam Maryam, Najmi-Varzaneh Farnaz, Rezaei Nima

机构信息

Department of Pediatrics;

Department of Pediatrics; ; Growth and Development Research Center;

出版信息

Iran J Pediatr. 2014 Apr;24(2):173-8.

PMID:25535536

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4268837/

Abstract

OBJECTIVE

Appropriate treatment of patients with Type 1 diabetes mellitus (T1DM) is necessary to avoid further complications. This study was performed to compare the efficacy of insulin Glargine and Aspart with NPH insulin and regular insulin regimen in a group of children with T1DM.

METHODS

Forty patients with T1DM were enrolled in this study. During run-in, all subjects were treated with conventional therapy consisting of twice-daily NPH and thrice-daily regular. Following randomization, 20 subjects received Glargine and Aspart and 20 subjects received NPH and Regular insulin.

FINDINGS

Mean HbA1c was 8.8% and 8.6% at first and 8.4% and 8.2% at the end of study for subjects randomized initially to Glargine and Aspart and for those randomized to NPH and Regular, respectively (P>0.05). Mean fasting blood glucose (FBS) of the subjects randomized initially to Glargine and Aspart was 217±101 mg/dL, with no significant difference to 196±75 mg/dL for those randomized to NPH and Regular (P=0.48). This was also true at the end of the study. The difference in total cholesterol and triglyceride between the two groups in the beginning of study and at the end did not show any significance.

CONCLUSION

The current study showed no significant difference in glycemic control [Glycated hemoglobin (HbA1c) and FBS] and lipid profile (total cholesterol and triglyceride) between two regimes.

摘要

目的

对1型糖尿病（T1DM）患者进行恰当治疗对于避免进一步并发症很有必要。本研究旨在比较甘精胰岛素和门冬胰岛素与中性鱼精蛋白锌胰岛素（NPH）和常规胰岛素方案在一组T1DM儿童中的疗效。

方法

40例T1DM患者纳入本研究。在导入期，所有受试者均接受由每日两次NPH和每日三次常规胰岛素组成的传统治疗。随机分组后，20名受试者接受甘精胰岛素和门冬胰岛素治疗，20名受试者接受NPH和常规胰岛素治疗。

结果

最初随机分组接受甘精胰岛素和门冬胰岛素治疗的受试者在研究开始时平均糖化血红蛋白（HbA1c）为8.8%，结束时为8.4%；最初随机分组接受NPH和常规胰岛素治疗的受试者在研究开始时平均HbA1c为8.6%，结束时为8.2%（P>0.05）。最初随机分组接受甘精胰岛素和门冬胰岛素治疗的受试者平均空腹血糖（FBS）为217±101mg/dL，与随机分组接受NPH和常规胰岛素治疗的受试者的196±75mg/dL相比无显著差异（P=0.48）。研究结束时情况同样如此。两组在研究开始时和结束时总胆固醇和甘油三酯的差异均无统计学意义。