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妊娠期使用法匹拉韦的结局:病例系列。

The outcomes of favipiravir exposure in pregnancy: a case series.

机构信息

Department of Medical Pharmacology, University of Health Sciences Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.

Department of Medical Pharmacology, Istanbul Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey.

出版信息

Arch Gynecol Obstet. 2023 May;307(5):1385-1395. doi: 10.1007/s00404-022-06615-z. Epub 2022 May 27.

Abstract

PURPOSE

As in vitro and in vivo studies reported antiviral efficacy against RNA viruses, favipiravir, a pyrazinecarboxamide derivative, has become one of the treatment options for COVID-19 in some countries including Turkey. Preclinical studies demonstrated the risk for teratogenicity and embryotoxicity. Hence, the drug is contraindicated during pregnancy. Although limited in numbers, case-based evaluations indicate that favipiravir might not be a major teratogen in human pregnancies. This study aimed to present and analyze the outcomes of favipiravir exposure during pregnancy.

METHODS

In this case series, the outcomes of nine pregnancies that were referred to the Teratology Information Service of Dokuz Eylul University Faculty of Medicine, Department of Medical Pharmacology between 01 April 2020 and 30 November 2021 were retrospectively evaluated.

RESULTS

One spontaneous abortion, two elective terminations, one preterm live delivery and five term live deliveries were detected. The premature newborn was reported dead on the 5th day of neonatal intensive care unit admission. Physiological jaundice and transient respiratory distress were recorded in two term infants. One term infant was antenatally diagnosed with renal pelviectasis, but the findings resolved postnatally without requiring intervention.

CONCLUSION

The data indicate that favipiravir is not likely to be a major teratogen. Yet, it is not possible to draw a definite conclusion due to methodological limitations. Favipiravir exposures during pregnancy should be followed up closely and the outcomes should be reported consistently.

摘要

目的

由于体外和体内研究报告了抗 RNA 病毒的抗病毒疗效,吡嗪羧酰胺衍生物法匹拉韦已成为包括土耳其在内的一些国家治疗 COVID-19 的选择之一。临床前研究表明有致畸性和胚胎毒性风险。因此,该药在怀孕期间禁用。尽管数量有限,但基于病例的评估表明,法匹拉韦在人类妊娠中可能不是主要的致畸剂。本研究旨在报告和分析妊娠期暴露于法匹拉韦的结果。

方法

在本病例系列研究中,回顾性评估了 2020 年 4 月 1 日至 2021 年 11 月 30 日期间,九例妊娠病例转诊至多乌埃佐尔大学医学院医学药理学毒理学信息服务中心的结果。

结果

发现一例自然流产,两例选择性终止妊娠,一例早产活产和五例足月活产。早产新生儿在新生儿重症监护病房入院后第 5 天死亡。两名足月婴儿记录到生理性黄疸和短暂性呼吸窘迫。一名足月婴儿产前诊断为肾盂扩张,但产后无需干预即恢复正常。

结论

数据表明法匹拉韦不太可能是主要的致畸剂。然而,由于方法学限制,尚无法得出明确结论。应密切监测妊娠期暴露于法匹拉韦的情况,并一致报告结果。

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