Department of Endocrinology, Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Diabetes Care. 2021 Sep;44(9):2069-2077. doi: 10.2337/dc21-0472. Epub 2021 Jul 30.
To compare the risk of severe adverse pregnancy complications in women with preexisting diabetes.
Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins.
Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI -0.01, 0.04]; adjusted risk difference -0.003 [95% CI -0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (-0.032 [95% CI -0.064, 0.000]) and after (-0.036 [95% CI -0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference -0.181 [95% CI -0.300, -0.062]) and the second trimester (6.1% vs. 6.3% [43 vs. 45 mmol/mol]; -0.139 [95% CI -0.232, -0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference -0.030 [95% CI -0.058, -0.002]), preeclampsia (6.4% vs. 10.0%; -0.036 [95% CI -0.064, -0.007]), and stillbirth (0.4% vs. 1.8%; -0.013 [95% CI -0.024, -0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment.
Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.
比较患有糖尿病的女性发生严重妊娠并发症的风险。
这是一项多中心、前瞻性队列研究，旨在评估使用地特胰岛素（德谷胰岛素）治疗与使用其他基础胰岛素治疗的患者，新生儿无主要先天畸形或围产期或新生儿死亡的比例（主要终点）。
在纳入的 1457 名女性中，727 名接受了德谷胰岛素治疗，730 名接受了其他基础胰岛素治疗。新生儿无主要先天畸形或围产期或新生儿死亡的比例在德谷胰岛素组（97.0%）和其他基础胰岛素组（95.5%）之间相似（粗风险差异 0.015[95%CI-0.01，0.04]；调整风险差异-0.003[95%CI-0.03，0.03]）。主要畸形（严重畸形加轻微畸形）的粗患病率为 9.4%对 12.6%，在调整混杂因素之前（-0.032[95%CI-0.064，0.000]）和之后（-0.036[95%CI-0.081，0.009]），风险差异相似。初步数据显示，在孕早期（6.5%比 6.7%[48 比 50mmol/mol]；估计平均差异-0.181[95%CI-0.300，-0.062]）和孕中期（6.1%比 6.3%[43 比 45mmol/mol]；-0.139[95%CI-0.232，-0.046]），母亲的血红蛋白 A1c 水平较低，且严重低血糖（6.0%比 9.0%；风险差异-0.030[95%CI-0.058，-0.002]）、子痫前期（6.4%比 10.0%；-0.036[95%CI-0.064，-0.007]）和死胎（0.4%比 1.8%；-0.013[95%CI-0.024，-0.002]）的发生率较低，与其他基础胰岛素相比。然而，调整后差异无统计学意义。
地特胰岛素与其他基础胰岛素相比，发生重大先天畸形、围产儿或新生儿死亡、低血糖、子痫前期和死胎的风险相似。
