Risk of congenital malformations for asthmatic pregnant women using a long-acting β2-agonist and inhaled corticosteroid combination versus higher-dose inhaled corticosteroid monotherapy
Risk of congenital malformations for asthmatic pregnant women using a long-acting β2-agonist and inhaled corticosteroid combination versus higher-dose inhaled corticosteroid monotherapy
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DOI：
10.1016/j.jaci.2014.07.051
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发表时间：
2015-01-01
影响因子：
14.2
通讯作者：
Blais, Lucie
中科院分区：
文献类型：
--
作者：
Eltonsy, Sherif;Forget, Amelie;Blais, Lucie
背景资料：当低剂量吸入性皮质类固醇（ICS）不足时，目前管理妊娠期间持续性哮喘的建议包括添加长效β（2）-激动剂（LABA）或增加ICS剂量。然而，没有数据可以帮助临床医生评估孕期最安全的治疗方案。目的：我们试图比较在妊娠早期暴露于LABA加ICS联合治疗的哮喘女性和暴露于较高剂量ICS单药治疗的哮喘女性发生主要先天性畸形的风险。方法：建立了一个1990年1月至2009年3月期间分娩的妊娠早期暴露于ICS的哮喘孕妇队列。主要结局是出生时或出生后第一年内记录的严重畸形。如下建立了两个亚队列：（1）LABA+低剂量ICS联合用药者或中剂量ICS使用者，和（2）LABA+中剂量ICS联合用药者或高剂量ICS使用者。广义估计方程被用来比较各组之间的主要畸形的风险。结果：在一个子队列中，有643名妇女谁使用LABA加低剂量ICS和305谁使用中等剂量ICS;其他子队列包括198用户的LABA加中等剂量ICS和156用户的高剂量ICS。主要畸形的患病率分别为6.9%和7.2%。主要畸形的调整优势比为1.1（95% CI，0.6-1.9）与中等剂量ICS相比，LABA+低剂量ICS和1.2（95%CI，0.5-2.7），当使用LABA加中等剂量ICS时，与使用高剂量ICS相比。LABA + ICS联合治疗和较高剂量的ICS单药治疗的严重畸形风险相似，表明妊娠期间可以考虑两种治疗选择。
Background: Current recommendations for managing persistent asthma during pregnancy when low-dose inhaled corticosteroids (ICSs) are insufficient include adding a long-acting beta(2)-agonist (LABA) or increasing the ICS dose. However, there are no data to help clinicians evaluate the safest regimen during pregnancy.Objective: We sought to compare the risk of major congenital malformations in asthmatic women exposed to a LABA plus ICS combination and those exposed to ICS monotherapy at higher doses during the first trimester.Methods: A cohort of asthmatic pregnant women exposed to ICSs during the first trimester who delivered between January 1990 and March 2009 was established. The primary outcome was major malformation recorded at birth or during the first year of life. Two subcohorts were established as follows: (1) users of a LABA plus low-dose ICS combination or users of a medium-dose ICS and (2) users of a LABA plus medium-dose ICS combination or users of a high-dose ICS. Generalized estimating equations were used to compare the risk of major malformations between the groups.Results: In one subcohort there were 643 women who used a LABA plus low-dose ICS and 305 who used a medium-dose ICS; the other subcohort included 198 users of a LABA plus medium-dose ICS and 156 users of a high-dose ICS. The prevalence of major malformations was 6.9% and 7.2%, respectively. The adjusted odds ratio for major malformations was 1.1 (95% CI, 0.6-1.9) when a LABA plus low-dose ICS was used compared with a medium-dose ICS and 1.2 (95% CI, 0.5-2.7) when a LABA plus medium-dose ICS was used compared with a high-dose ICS.Conclusion: The risk of major malformations was similar with a LABA plus ICS combination and ICS monotherapy at higher doses, suggesting that both therapeutic options can be considered during pregnancy.