Beaujon University Hospital Paris VII University, Clichy, France; Geneva University Hospital, Geneva, Switzerland.
Aliment Pharmacol Ther. 2014 Aug;40(4):363-73. doi: 10.1111/apt.12833. Epub 2014 Jun 30.
The safety of anti-tumour necrosis factor (TNF) agents during pregnancy is a major concern for child-bearing women and physicians.
To assess the impact of anti-TNF therapy on adverse pregnancy and foetal outcomes in women with inflammatory bowel disease (IBD).
Pregnancies occurring during anti-TNF treatment or less than 3 months after its cessation in IBD patients followed in GETAID centres were recorded from January 2009 to December 2010. Ninety-nine pregnancies in women without anti-TNF treatment were identified from the CESAME registry. We compared pregnancy and neonatal outcomes by a case-control study.
In the 124 IBD patients followed, 133 pregnancies were reported. At the conception time, 23% of patients had active disease. Eighty-eight per cent (n = 117) of the 133 pregnancies followed until delivery resulted in 118 liveborns (one twin pregnancy). Complications were observed in 47 (35%) women and 24 (20%) newborns. In multivariate analysis, factors associated with pregnancy complications were: current smoking (P = 0.004), a B2 (stenotic) phenotype in CD women (P = 0.004), occurrence of a flare during pregnancy (P = 0.006) and a past history of complicated pregnancy (P = 0.007). Current smoking was the only factor associated with severe (i.e. potentially lethal) pregnancy complications (P = 0.02). Having IBD for more than 10 years prior to conception was associated with newborn complications (P = 0.007). No difference was found with the control group for any of the pregnancy and neonatal outcomes.
In our series, the safety profile of anti-TNF therapy during pregnancy and the neonatal period appears similar to control group of IBD women not treated with anti-TNF therapy.
抗肿瘤坏死因子（TNF）药物在怀孕期间的安全性是生育期妇女和医生关注的主要问题。
评估抗 TNF 治疗对炎症性肠病（IBD）患者妊娠和胎儿结局的影响。
从 2009 年 1 月至 2010 年 12 月，记录了在 GETAID 中心接受治疗的 IBD 患者在接受抗 TNF 治疗期间或停药后 3 个月内发生的妊娠情况。从 CESAME 登记处确定了 99 例未接受抗 TNF 治疗的女性的妊娠情况。我们通过病例对照研究比较了妊娠和新生儿结局。
在随访的 124 例 IBD 患者中，报告了 133 例妊娠。在受孕时，23%的患者处于疾病活动期。133 例妊娠中，有 117 例（88%）随访至分娩，最终有 118 例活产（1 例双胞胎妊娠）。47 例（35%）孕妇和 24 例（20%）新生儿出现并发症。多变量分析显示，与妊娠并发症相关的因素有：当前吸烟（P=0.004）、CD 女性 B2（狭窄）表型（P=0.004）、妊娠期间发生疾病活动（P=0.006）和既往复杂妊娠史（P=0.007）。当前吸烟是唯一与严重（即可能致命）妊娠并发症相关的因素（P=0.02）。受孕前 IBD 病史超过 10 年与新生儿并发症相关（P=0.007）。与未接受抗 TNF 治疗的 IBD 女性对照组相比，在任何妊娠和新生儿结局方面均未发现差异。
在我们的研究中，抗 TNF 治疗在妊娠和新生儿期的安全性似乎与未接受抗 TNF 治疗的 IBD 女性对照组相似。
