Ji Jing, He Zhangya, Yang Zhao, Mi Yang, Guo Na, Zhao Hong, Gao Jiayi, Ma Zhengfeei, Luo Xiaoqin, Han Zhen
Department of Obstetrics and Gynecology, Northwest Women's and Children's Hospital, Xi'an, China.
Department of Nutrition and Food Safety, School of Public Health, Xi'an Jiaotong University, Xi'an, China.
BMJ Open Diabetes Res Care. 2020 Apr;8(1). doi: 10.1136/bmjdrc-2019-001155.
To compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin used in pregnant women with diabetes.
A randomized study was conducted in diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes). All patients were randomly divided into two groups: IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR-IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR-NPH plan). Patients were enrolled during 12-28 gestation weeks and followed up until delivery.
Basal characteristics, such as age, enrollment gestational weeks, average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT) were similar between two groups. After 1 week of treatment, the FPG of IDet group were significantly lower than NPH group (p<0.05) and the time required to reach the targeted blood glucose level was significantly shorter (p<0.001). After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level. Maternal and neonatal outcomes were comparable between the two therapeutic approaches; however, the incidence of hypoglycemia in IDet group was remarkably lower than that of NPH group (p<0.05). The adverse drug reactions were rare and similar between the two groups.
For the treatment of gestational diabetes, both RRR-IDet plan and RRR-NPH plan were reported to control blood glucose effectively. Compared with NPH, IDet could control blood glucose and reached the targets faster and more effectively, thus reducing the number of insulin injections and the incidence of hypoglycemia in pregnant women without increasing adverse birth outcomes. Therefore, for pregnant women with gestational diabetes, who require insulin therapy, IDet would be an ideal basal insulin being worthy of promotion in clinical settings.
比较地特胰岛素（IDet）与中性鱼精蛋白锌胰岛素（NPH）用于糖尿病孕妇的疗效和安全性。
对糖尿病孕妇（n = 240）（包括132例孕前糖尿病患者和108例妊娠期糖尿病患者）进行了一项随机研究。所有患者随机分为两组：IDet组（n = 120），采用IDet加三餐前短效胰岛素诺和灵R治疗（RRR-IDet方案）；NPH组，采用NPH加三餐前诺和灵R治疗（RRR-NPH方案）。患者在妊娠12 - 28周期间入组，并随访至分娩。
两组患者的基础特征，如年龄、入组孕周、平均糖化血红蛋白（HbA1c）、空腹血糖（FPG）和口服葡萄糖耐量试验（OGTT）相似。治疗1周后，IDet组的FPG显著低于NPH组（p < 0.05），达到目标血糖水平所需时间显著缩短（p < 0.001）。治疗3个月后，两组的HbA1c水平均恢复正常，但HbA1c水平无显著差异。两种治疗方法的母婴结局具有可比性；然而，IDet组的低血糖发生率显著低于NPH组（p < 0.05）。两组的药物不良反应均少见且相似。
对于妊娠期糖尿病的治疗，RRR-IDet方案和RRR-NPH方案均能有效控制血糖。与NPH相比，IDet能更快速、有效地控制血糖并达到目标，从而减少孕妇胰岛素注射次数和低血糖发生率，且不增加不良分娩结局。因此，对于需要胰岛素治疗的妊娠期糖尿病孕妇，IDet是一种理想的基础胰岛素，值得在临床推广应用。
