Doder Zoran, Vanechanos Demi, Oster Manfred, Landgraf Wolfgang, Lin Stephen
Global Pharmacovigilance & Epidemiology, Sanofi, Bridgewater, New Jersey, US.
Medical Affairs, Diabetes Division, Sanofi-Aventis, Frankfurt, Germany.
Eur Endocrinol. 2015 Apr;11(1):17-20. doi: 10.17925/EE.2015.11.01.17. Epub 2015 Apr 11.
Pregnancies complicated by gestational diabetes or pre-existing type 1 or type 2 diabetes mellitus are associated with a higher rate of adverse outcomes compared with pregnancies in the background population. These outcomes include miscarriage, pre-term delivery, pre-eclampsia, perinatal mortality and congenital malformations. Insulin glulisine (Apidra, Sanofi) is a rapid-acting insulin analogue indicated for the treatment of adults, adolescents and children 6 years or older with diabetes mellitus where treatment with insulin is required. Here, all post-marketing and clinical trials safety data with insulin glulisine in pregnancy available to Sanofi up to June 2014 are summarised together with the findings of a comprehensive literature search. Cumulatively, a total of 303 pregnancy exposures to insulin glulisine were received. Of these 303 pregnancy exposures, there were 116 live births, 12 spontaneous abortions, two late foetal intra-uterine deaths (>28 weeks), three elective abortions and 170 cases without a known pregnancy outcome. There were six cases of congenital malformations; of these, there were five live births; in the other case a live birth was not confirmed. The congenital malformations reported to date do not reveal a pattern of defects. In conclusion, the evidence to date does not suggest a causal association between insulin glulisine and an increased risk of pregnancy complications or congenital malformations.
与普通人群中的妊娠相比，患有妊娠期糖尿病或孕前1型或2型糖尿病的妊娠出现不良结局的发生率更高。这些结局包括流产、早产、子痫前期、围产期死亡率和先天性畸形。赖脯胰岛素（Apidra，赛诺菲）是一种速效胰岛素类似物，适用于需要胰岛素治疗的6岁及以上糖尿病成人、青少年和儿童。本文汇总了赛诺菲截至2014年6月可获得的所有赖脯胰岛素在孕期的上市后和临床试验安全性数据，并结合全面文献检索结果进行分析。累计共有303例妊娠暴露于赖脯胰岛素。在这303例妊娠暴露中，有116例活产、12例自然流产、2例晚期胎儿宫内死亡（>28周）、3例选择性流产以及170例妊娠结局未知的病例。有6例先天性畸形；其中，有5例活产；另一例活产情况未得到证实。迄今为止报告的先天性畸形未显示出缺陷模式。总之，迄今为止的证据并不表明赖脯胰岛素与妊娠并发症风险增加或先天性畸形之间存在因果关系。
