Dalfrà Maria Grazia, Soldato Angela, Moghetti Paolo, Lombardi Simonetta, Vinci Carmela, De Cata Angela Pia, Romanelli Tiziana, Bonomo Matteo, Sciacca Laura, Tata Federica, Ragazzi Eugenio, Filippi Alessio, Burlina Silvia, Lapolla Annunziata
a DPT Medicina, Università di Padova , Padova , Italy .
b DPT Medicina, Università di Verona , Verona , Italy .
J Matern Fetal Neonatal Med. 2016;29(7):1061-5. doi: 10.3109/14767058.2015.1033619. Epub 2015 Apr 21.
The aim of this study was to study the efficacy and safety of long-acting insulin analog insulin lispro protamine suspension (ILPS) in diabetic pregnant women.
In a multicenter observational retrospective study, we evaluated pregnancy outcome in 119 women affected by type 1 diabetes and 814 with gestational diabetes (GDM) treated during pregnancy with ILPS, compared with a control group treated with neutral protamine hagedorn (NPH) insulin.
Among type 1 diabetic patients, fasting blood glucose at the end of pregnancy was significantly lower in ILPS-treated than in NPH-treated patients. HbA1c levels across pregnancy did not differ between groups. Caesarean section and preterm delivery rates were significantly lower in the ILPS-women. Fetal outcomes were similar in the ILPS and NPH groups. Among GDM women, fasting blood glucose at the end of pregnancy was significantly lower in ILPS-treated than in NPH-treated patients. Duration of gestation was significantly longer, caesarian section and preterm delivery rates were lower in the ILPS-treated group. In addition, there were significantly fewer babies with an excessive ponderal index or neonatal hypoglycemic episodes in the ILPS group than in the NPH group.
Association of ILPS with rapid-acting analogs in pregnancy is safe in terms of maternal and fetal outcomes.
本研究旨在探讨长效胰岛素类似物赖脯胰岛素鱼精蛋白混悬液(ILPS)在糖尿病孕妇中的疗效和安全性。
在一项多中心观察性回顾性研究中,我们评估了119例1型糖尿病孕妇和814例妊娠期糖尿病(GDM)孕妇在孕期接受ILPS治疗的妊娠结局,并与接受中性鱼精蛋白锌胰岛素(NPH)治疗的对照组进行比较。
在1型糖尿病患者中,妊娠末期接受ILPS治疗的患者空腹血糖显著低于接受NPH治疗的患者。两组患者孕期的糖化血红蛋白(HbA1c)水平无差异。接受ILPS治疗的孕妇剖宫产和早产率显著较低。ILPS组和NPH组的胎儿结局相似。在GDM孕妇中,妊娠末期接受ILPS治疗的患者空腹血糖显著低于接受NPH治疗的患者。ILPS治疗组的妊娠期显著延长,剖宫产和早产率较低。此外,ILPS组出生体重指数过高或发生新生儿低血糖事件的婴儿明显少于NPH组。
就母婴结局而言,ILPS与速效类似物联合用于孕期是安全的。