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临床试验与妊娠。

Clinical trials and pregnancy.

作者信息

Waitt Catriona, Astill Denise, Zavala Eleonor, Karron Ruth A, Faden Ruth R, Stratton Pamela, Temkin Sarah M, Clayton Janine A

机构信息

University of Liverpool, Liverpool, UK.

Foetal Anti-Convulsant Syndrome New Zealand, PO Box 82-175, Highland Park, Auckland, 2143 New Zealand.

出版信息

Commun Med (Lond). 2022 Oct 25;2:132. doi: 10.1038/s43856-022-00198-1. eCollection 2022.

DOI:10.1038/s43856-022-00198-1
PMID:36299562
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9593973/
Abstract

Traditionally, there has been a reluctance to involve pregnant people in clinical trials due to complex ethical issues surrounding the risk to unborn babies. However it is crucial that new interventions are safe and effective for all patients and ensuring this can be difficult to achieve in the absence of clinical trials.

摘要

传统上,由于围绕未出生婴儿风险的复杂伦理问题,人们一直不愿让孕妇参与临床试验。然而,至关重要的是,新的干预措施对所有患者都安全有效,而在没有临床试验的情况下,要确保这一点可能很难实现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/354b7f8cad1e/43856_2022_198_Figh_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/3fc9d50c903c/43856_2022_198_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/0849de18a56b/43856_2022_198_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/c65033eaa254/43856_2022_198_Figc_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/ab524a364a7f/43856_2022_198_Figd_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/565a43ba9441/43856_2022_198_Fige_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/c33856b0e16e/43856_2022_198_Figf_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/dc09a4839f6a/43856_2022_198_Figg_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/354b7f8cad1e/43856_2022_198_Figh_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/3fc9d50c903c/43856_2022_198_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/0849de18a56b/43856_2022_198_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/c65033eaa254/43856_2022_198_Figc_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/ab524a364a7f/43856_2022_198_Figd_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/565a43ba9441/43856_2022_198_Fige_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/c33856b0e16e/43856_2022_198_Figf_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/dc09a4839f6a/43856_2022_198_Figg_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/67d1/9596394/354b7f8cad1e/43856_2022_198_Figh_HTML.jpg

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本文引用的文献

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Exclusion of Reproductive-aged Women in COVID-19 Vaccination and Clinical Trials.将育龄期女性排除在 COVID-19 疫苗接种和临床试验之外。
Womens Health Issues. 2022 Nov-Dec;32(6):557-563. doi: 10.1016/j.whi.2022.06.004. Epub 2022 Jun 15.
2
Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study.妊娠期 COVID-19 疫苗的安全性:加拿大国家疫苗安全(CANVAS)网络队列研究。
Lancet Infect Dis. 2022 Nov;22(11):1553-1564. doi: 10.1016/S1473-3099(22)00426-1. Epub 2022 Aug 11.
3
Monkeypox vaccines in pregnancy: lessons must be learned from COVID-19.
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Am J Physiol Heart Circ Physiol. 2025 Mar 1;328(3):H433-H440. doi: 10.1152/ajpheart.00751.2024. Epub 2025 Jan 20.
4
Oxidative Stress Induced by Antivirals: Implications for Adverse Outcomes During Pregnancy and in Newborns.抗病毒药物诱导的氧化应激:对妊娠及新生儿不良结局的影响
Antioxidants (Basel). 2024 Dec 12;13(12):1518. doi: 10.3390/antiox13121518.
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Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya.这些数据流向何处?利用临床试验的筛查结果来估计肯尼亚基利菲成年人中乙肝病毒感染的人群患病率。
J Virus Erad. 2023 Dec 2;9(4):100355. doi: 10.1016/j.jve.2023.100355. eCollection 2023 Dec.
孕期的猴痘疫苗:必须从新冠疫情中吸取教训。
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JAMA Netw Open. 2022 Jun 1;5(6):e2219133. doi: 10.1001/jamanetworkopen.2022.19133.
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