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卡西瑞维单抗/依米德维单抗(REGEN-COV)用于COVID-19孕妇的疗效和安全性:文献综述及COVID-19国际药物妊娠登记处的见解

Efficacy and safety of casirivimab/imdevimab (REGEN-COV) in pregnant individuals with COVID-19: Literature review and insights from the COVID-19 International Drug Pregnancy Registry.

作者信息

Wyszynski Diego F, Yau Vincent, Keebler Daniel, Renz Cheryl, Ives Jane, Fitzgibbon Andrew, Shulman Lee P

机构信息

Clinical Research Group, Thermo Fisher Scientific Inc., London, UK.

Product Development., Genentech, Inc., South San Francisco, California, USA.

出版信息

Obstet Med. 2025 Jun 9:1753495X251343113. doi: 10.1177/1753495X251343113.

Abstract

INTRODUCTION

Casirivimab/imdevimab (CAS/IMD) comprises two monoclonal antibodies that neutralize SARS-CoV-2. Pregnant individuals were excluded from initial trials, limiting safety data.

METHODS

The COVID-19 International Drug Pregnancy Registry enrolled 53 pregnant women treated with CAS/IMD, with 34 live births.

RESULTS

No safety concerns were identified.

DISCUSSION AND CONCLUSIONS

The findings of the COVID-PR study support the safety of CAS/IMD during pregnancy, adding to the growing body of evidence on COVID-19 treatments for this population. The available literature shows that CAS/IMD is effective in preventing the progression to severe COVID-19 in pregnant individuals. The drugs are well-tolerated, and there is no compelling evidence of adverse maternal or neonatal outcomes. The results from the COVID-PR study are consistent with those of the broader literature.

摘要

引言

卡西瑞维单抗/依米德维单抗(CAS/IMD)由两种可中和严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的单克隆抗体组成。孕妇被排除在初始试验之外,这限制了安全性数据。

方法

COVID-19国际药物孕期登记处招募了53名接受CAS/IMD治疗的孕妇,其中34名顺利分娩。

结果

未发现安全问题。

讨论与结论

COVID-PR研究结果支持CAS/IMD在孕期的安全性,为该人群中关于COVID-19治疗的越来越多的证据增添了内容。现有文献表明,CAS/IMD可有效预防孕妇发展为重症COVID-19。这些药物耐受性良好,没有令人信服的证据表明会出现不良的母体或新生儿结局。COVID-PR研究结果与更广泛的文献一致。

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