Lessons from examining the safety of drugs for COVID-19 during pregnancy.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2026-03-18 DOI:10.1080/14740338.2026.2637649

Nunzia Esposito, Antonio Riccardo Buonomo, Isabella Di Filippo, Elisabetta Forte, Emilia Trucillo, Ivan Gentile, Nicola Schiano Moriello

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引用次数: 0

Abstract

Introduction: Pregnant women represent a vulnerable population during the COVID-19 pandemic, facing increased risks of severe disease and adverse obstetric outcomes, yet they have been largely excluded from pivotal therapeutic clinical trials, leaving a critical evidence gap for treatment decisions.

Areas covered: This review examines the available evidence on the safety and efficacy of COVID-19 therapies during pregnancy, including oral antivirals (nirmatrelvir/ritonavir, molnupiravir), intravenous remdesivir, monoclonal antibodies, corticosteroids, and immunomodulators (tocilizumab, baricitinib). A literature search was conducted using MEDLINE/PubMed for English-language articles published from March 2020 to December 2023, including studies of any design reporting maternal and neonatal outcomes.

Expert opinion: The COVID-19 pandemic exposed a critical gap in clinical research through the systematic exclusion of pregnant women from therapeutic trials. Current evidence, though largely observational, supports vaccination as the primary preventive strategy, nirmatrelvir/ritonavir for outpatients at risk of progression, and remdesivir plus corticosteroids for hospitalized patients requiring oxygen supplementation.

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检查妊娠期间抗COVID-19药物安全性的经验教训。

导语：在COVID-19大流行期间，孕妇是弱势群体，面临严重疾病和不良产科结局的风险增加，但她们在很大程度上被排除在关键的治疗性临床试验之外，这给治疗决策留下了关键的证据空白。涵盖领域：本综述审查了妊娠期间COVID-19治疗的安全性和有效性的现有证据，包括口服抗病毒药物（尼马特利韦/利托那韦、莫硝皮韦）、静脉注射瑞德西韦、单克隆抗体、皮质类固醇和免疫调节剂（托珠单抗、巴西替尼）。使用MEDLINE/PubMed进行文献检索，检索2020年3月至2023年12月发表的英语文章，包括任何设计报告孕产妇和新生儿结局的研究。专家意见：COVID-19大流行通过系统地将孕妇排除在治疗试验之外，暴露了临床研究的关键空白。目前的证据，虽然主要是观察性的，支持接种疫苗作为主要的预防策略，尼马特利韦/利托那韦用于有进展风险的门诊患者，瑞德西韦加皮质类固醇用于需要补充氧气的住院患者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.