Use of asthma medication during pregnancy and risk of specific congenital anomalies: A European case-malformed control study

作者：Garne Ester^*; Hansen Anne Vinkel; Morris Joan; Zaupper Louise; Addor Marie Claude; Barisic Ingeborg; Gatt Miriam; Lelong Nathalie; Klungsoyr Kari; O'Mahony Mary; Nelen Vera; Neville Amanda J; Pierini Anna; Tucker David; de Walle Hermien; Wiesel Awi; Loane Maria; Dolk Helen

来源：Journal of Allergy and Clinical Immunology, 2015, 136(6): 1496-U116.

DOI：10.1016/j.jaci.2015.05.043

• Asthma medication
• congenital anomalies
• pregnancy
• first trimester exposure
• inhaled beta(2)-agonists
• inhaled corticosteroids

Background: Pregnant women with asthma need to take medication during pregnancy.
Objective: We sought to identify whether there is an increased risk of specific congenital anomalies after exposure to antiasthma medication in the first trimester of pregnancy.
Methods: We performed a population-based case-malformed control study testing signals identified in a literature review. Odds ratios (ORs) of exposure to the main groups of asthma medication were calculated for each of the 10 signal anomalies compared with registrations with nonchromosomal, nonsignal anomalies as control registrations. In addition, exploratory analyses were done for each nonsignal anomaly. The data set included 76,249 registrations of congenital anomalies from 13 EUROmediCAT registries.
Results: Cleft palate (OR, 1.63; 95% CI, 1.05-2.52) and gastroschisis (OR, 1.89; 95% CI, 1.12-3.20) had significantly increased odds of exposure to first-trimester use of inhaled beta(2)-agonists compared with nonchromosomal control registrations. Odds of exposure to salbutamol were similar. Nonsignificant ORs of exposure to inhaled beta(2)-agonists were found for spina bifida, cleft lip, anal atresia, severe congenital heart defects in general, or tetralogy of Fallot. None of the 4 literature signals of exposure to inhaled steroids were confirmed (cleft palate, cleft lip, anal atresia, and hypospadias). Exploratory analyses found an association between renal dysplasia and exposure to the combination of long-acting beta(2)-agonists and inhaled corticosteroids (OR, 3.95; 95% CI, 1.99-7.85).
Conclusions: The study confirmed increased odds of first-trimester exposure to inhaled beta(2)-agonists for cleft palate and gastroschisis and found a potential new signal for renal dysplasia associated with combined long-acting beta(2)-agonists and inhaled corticosteroids. Use of inhaled corticosteroids during the first trimester of pregnancy seems to be safe in relation to the risk for a range of specific major congenital anomalies.

• 出版日期2015-12