1型糖尿病妊娠的胎儿及围产期结局：一项在322名受试者中比较门冬胰岛素与普通胰岛素的随机研究。

Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects.

作者信息

Hod Moshe, Damm Peter, Kaaja Risto, Visser Gerard H A, Dunne Fidelma, Demidova Irina, Hansen Anne-Sofie Pade, Mersebach Henriette

机构信息

Perinatal Division, Helen Schneider Hospital for Women, Rabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Petah-Tiqva, Israel.

出版信息

Am J Obstet Gynecol. 2008 Feb;198(2):186.e1-7. doi: 10.1016/j.ajog.2007.08.005. Epub 2007 Oct 1.

DOI:10.1016/j.ajog.2007.08.005

PMID:17905178

Abstract

OBJECTIVE

The objective of the study was a comparison of insulin aspart (IAsp) with human insulin (HI) in basal-bolus therapy with neutral protamine Hagedorn for fetal and perinatal outcomes of type 1 diabetes in pregnancy.

STUDY DESIGN

This was a randomized, parallel, open-label, controlled, multicenter, multinational study. Subjects were pregnant (gestational age; <10 weeks) or planning pregnancy at enrollment. Three hundred twenty-two women with type 1 diabetes received IAsp (n = 157) or HI (n = 165).

RESULTS

For IAsp and HI, respectively, there were 137 and 131 live births and 14 and 21 fetal losses. Perinatal mortality was 14 and 22 per 1000 births; number of congenital malformations were 6 and 9; mean (SEM) birthweight corrected for gestational age was 3438 g (71.5) and 3555 g (72.9; P = .091). Mean gestational age was 37.6 vs 37.4 weeks. Preterm delivery occurred in 20.3% (IAsp) and 30.6% (HI) of pregnancies (P = .053).

CONCLUSION

The fetal outcome using IAsp was comparable with HI with a tendency toward fewer fetal losses and preterm deliveries.

摘要

目的

本研究的目的是比较门冬胰岛素（IAsp）与重组人胰岛素（HI）在基础-餐时疗法联合中效低精蛋白胰岛素治疗中对妊娠1型糖尿病胎儿及围产期结局的影响。

研究设计

这是一项随机、平行、开放标签、对照、多中心、跨国研究。受试者在入组时已怀孕（孕周<10周）或计划怀孕。322例1型糖尿病女性接受了IAsp（n = 157）或HI（n = 165）治疗。

结果

IAsp组和HI组分别有137例和131例活产，14例和21例胎儿丢失。围产儿死亡率分别为每1000例出生中有14例和22例；先天性畸形数分别为6例和9例；校正孕周后的平均（SEM）出生体重分别为3438 g（71.5）和3555 g（72.9；P = 0.091）。平均孕周分别为37.6周和37.4周。20.3%（IAsp组）和30.6%（HI组）的妊娠发生早产（P = 0.053）。