Naftel Jennifer, Jackson David J, Coleman Matthew, d'Ancona Grainne, Heaney Liam G, Dennison Paddy, Bossios Apostolos, Rupani Hitasha
National Institute for Health Research Southampton Biomedical Research Centre and Department of Respiratory Medicine, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
School of Immunology and Microbial Sciences, King's College London, London, UK; Guy's Severe Asthma Centre, Guy's and St Thomas' NHS Foundation Trust Hospital, London, UK.
Lancet Respir Med. 2025 Jan;13(1):80-91. doi: 10.1016/S2213-2600(24)00174-7. Epub 2024 Aug 28.
Uncontrolled asthma is associated with an increased risk of adverse perinatal outcomes. Asthma biologics reduce exacerbation frequency, are steroid sparing, and improve quality of life in people with severe asthma. However, evidence for the use and safety of asthma biologics during pregnancy is scarce, largely because pregnant women were excluded from clinical trials. To help to support clinical teams, we conducted an international modified Delphi study. 141 panellists from 32 countries who were involved in the care of people with severe asthma completed two rounds of online surveys covering key areas surrounding the use of asthma biologics in pregnancy. The results from this international Delphi study emphasise risk versus benefit discussions and shared clinical decision making, with consensus among panellists that asthma biologics can be used during conception and throughout pregnancy, initiated during pregnancy in line with prescribing criteria for non-pregnant people, and initiated or continued during breastfeeding. Collating data through international registries remains essential to inform clinical guidelines.
未控制的哮喘与不良围产期结局风险增加相关。哮喘生物制剂可降低加重频率、减少类固醇使用,并改善重度哮喘患者的生活质量。然而,关于哮喘生物制剂在孕期使用及安全性的证据匮乏,主要原因是孕妇被排除在临床试验之外。为帮助支持临床团队,我们开展了一项国际改良德尔菲研究。来自32个国家的141名参与重度哮喘患者护理的小组成员完成了两轮在线调查,内容涵盖孕期使用哮喘生物制剂的关键领域。这项国际德尔菲研究的结果强调了风险与获益的讨论以及共同的临床决策制定,小组成员达成共识,即哮喘生物制剂可在受孕期间及整个孕期使用,可在孕期按照非孕妇的处方标准开始使用,并可在哺乳期开始使用或继续使用。通过国际注册机构整理数据对于为临床指南提供信息仍然至关重要。