一项随机对照试验，比较一日两次甘精胰岛素与速效胰岛素类似物混合使用与标准中性鱼精蛋白锌胰岛素（NPH）疗法在新诊断1型糖尿病中的效果。

A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine Hagedorn (NPH) therapy in newly diagnosed type 1 diabetes.

作者信息

Hassan Krishnavathana, Rodriguez Luisa M, Johnson Susan E, Tadlock Susanne, Heptulla Rubina A

机构信息

Department of Pediatric Endocrinology and Metabolism, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.

出版信息

Pediatrics. 2008 Mar;121(3):e466-72. doi: 10.1542/peds.2007-1679. Epub 2008 Feb 25.

DOI:10.1542/peds.2007-1679

PMID:18299307

Abstract

OBJECTIVE

Insulin glargine is difficult to use for children due to the number of injections required because it is claimed to be immiscible with rapid-acting insulin analogs. For this study, we hypothesized that treating new-onset type 1 diabetes with twice-daily insulin glargine plus a rapid-acting insulin analog mixed in the same syringe would result in better glycosylated hemoglobin than twice-daily neutral protamine Hagedorn with a rapid-acting insulin analog (standard treatment).

METHODS

Forty-two patients with new-onset type 1 diabetes were started on standard treatment. Three months after diagnosis, if patients were found compliant and had a glycosylated hemoglobin level of < or = 9%, then they were randomly assigned either to receive insulin glargine twice daily mixed with a rapid-acting insulin analog or to continue on standard treatment for 3 more months. Additional lunchtime rapid-acting insulin analog injections were given for the insulin glargine group as necessary.

RESULTS

Nineteen patients in the insulin glargine group and 17 in the neutral protamine Hagedorn group completed the study. The glycosylated hemoglobin level at baseline was 6.8% +/- 1% vs 6.9% +/- 1% and at poststudy was 6.7% +/- 1.3% vs 7.6% +/- 1% in the insulin glargine versus neutral protamine Hagedorn group, respectively. Two patients in the insulin glargine group required lunch rapid-acting insulin analog in the last month of the study. Although both groups were encouraged to contact the principal investigator with all queries, more in the insulin glargine arm opted to do so.

CONCLUSIONS

Glycemic control with insulin glargine mixed with a rapid-acting insulin analog given twice daily seems significantly more effective than the standard therapy in newly diagnosed type 1 diabetes. Furthermore, it decreases pain and burden of injections for children with diabetes by allowing patients to mix glargine with rapid-acting insulin analog.

摘要

目的

由于所需注射次数较多，且据称甘精胰岛素与速效胰岛素类似物不相溶，因此儿童使用甘精胰岛素存在困难。在本研究中，我们假设对于新诊断的1型糖尿病患者，每日两次注射甘精胰岛素并在同一注射器中混合速效胰岛素类似物进行治疗，其糖化血红蛋白水平将优于每日两次注射中性鱼精蛋白锌胰岛素加速效胰岛素类似物（标准治疗）。

方法

42例新诊断的1型糖尿病患者开始接受标准治疗。诊断后3个月，如果患者依从性良好且糖化血红蛋白水平≤9%，则将他们随机分配，分别接受每日两次混合速效胰岛素类似物的甘精胰岛素治疗，或继续标准治疗3个月。甘精胰岛素组根据需要额外给予午餐时速效胰岛素类似物注射。

结果

甘精胰岛素组19例患者和中性鱼精蛋白锌胰岛素组17例患者完成了研究。甘精胰岛素组与中性鱼精蛋白锌胰岛素组的基线糖化血红蛋白水平分别为6.8%±1%和6.9%±1%，研究结束时分别为6.7%±1.3%和7.6%±1%。甘精胰岛素组有2例患者在研究的最后1个月需要午餐时注射速效胰岛素类似物。尽管鼓励两组患者就所有问题联系主要研究者，但甘精胰岛素组中有更多患者选择这样做。