Meyer Antoine, Drouin Jérôme, Weill Alain, Carbonnel Franck, Dray-Spira Rosemary
EPIPHARE, Épidémiologie des produits de santé, ANSM-CNAM, Denis, France.
Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Le Kremlin Bicêtre, France.
Aliment Pharmacol Ther. 2021 Aug;54(3):302-311. doi: 10.1111/apt.16448. Epub 2021 Jun 23.
Data about thiopurines or anti-TNF use during pregnancy in women with inflammatory bowel diseases (IBD) are reassuring. However, many studies are based upon small sample sizes.
To assess IBD medication safety during pregnancy.
Using the French national health database, which covers more than 99% of the French population, around 65 000 000 people, we identified pregnancies ending with a birth in IBD patients in France between 2010 and 2018. Pregnancy outcomes (vital status at birth, birth term, and weight for gestational age) were compared according to treatment exposure during pregnancy using propensity score-weighted marginal logistic regression models.
27 729 pregnancies were included: 3554 were exposed to thiopurines monotherapy, 3525 to anti-TNF monotherapy, 839 to combination therapy, and 19 811 unexposed. Pregnancies exposed to thiopurines monotherapy compared to unexposed pregnancies more frequently resulted in stillbirths (1.0% vs 0.5%, aOR 2.04; 95%CI: 1.18-3.55), preterm birth (12.3% vs 7.1%, aOR 1.76; 95%CI: 1.55-2.00), large for gestational age (10.6% vs 8.4%, aOR 1.32; 95%CI: 1.13-1.53) and less frequently in small for gestational age (9.6% vs 11.1%, aOR 0.79; 95%CI: 0.67-0.92). By contrast, pregnancies exposed to anti-TNF monotherapy were not different from unexposed pregnancies as regards to these outcomes. Compared to unexposed pregnancies, those exposed to combination therapy more frequently resulted in preterm births (aOR 1.55; 95%CI: 1.15-2.11) and larger for gestational age (aOR 1.61; 95%CI: 1.13-2.29) but did not differ as regards to stillbirths.
Pregnancies exposed to thiopurines more frequently resulted in stillbirths, preterm births and large for gestational age compared to pregnancies exposed to anti-TNF or unexposed pregnancies. By contrast, pregnancies exposed to anti-TNF monotherapy were not associated with these outcomes.
关于炎症性肠病（IBD）女性孕期使用硫唑嘌呤或抗TNF药物的数据令人安心。然而，许多研究基于小样本量。
评估孕期IBD药物的安全性。
利用覆盖超过99%法国人口（约6500万人）的法国国家健康数据库，我们确定了2010年至2018年期间法国IBD患者中以分娩结束的妊娠。使用倾向评分加权边际逻辑回归模型，根据孕期治疗暴露情况比较妊娠结局（出生时生命状态、出生孕周和出生体重）。
纳入27729例妊娠：3554例暴露于硫唑嘌呤单药治疗，3525例暴露于抗TNF单药治疗，839例暴露于联合治疗，19811例未暴露。与未暴露妊娠相比，暴露于硫唑嘌呤单药治疗的妊娠更常导致死产（1.0%对0.5%，调整后比值比[aOR]2.04；95%置信区间[CI]：1.18 - 3.55）、早产（12.3%对7.1%，aOR 1.76；95%CI：1.55 - 2.00）、大于胎龄儿（10.6%对8.4%，aOR 1.32；95%CI：1.13 - 1.53），而小于胎龄儿较少见（9.6%对11.1%，aOR 0.79；95%CI：0.67 - 0.92）。相比之下，暴露于抗TNF单药治疗的妊娠在这些结局方面与未暴露妊娠无差异。与未暴露妊娠相比，暴露于联合治疗的妊娠更常导致早产（aOR 1.55；95%CI：1.15 - 2.11）和大于胎龄儿（aOR 1.61；95%CI：1.13 - 2.29），但在死产方面无差异。
与暴露于抗TNF或未暴露的妊娠相比，暴露于硫唑嘌呤的妊娠更常导致死产、早产和大于胎龄儿。相比之下，暴露于抗TNF单药治疗的妊娠与这些结局无关。
