Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials
Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials
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DOI：
10.1093/cid/ciaa444
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发表时间：
2020-08-01
影响因子：
11.8
通讯作者：
Waldorf, Kristina M. Adams
中科院分区：
文献类型：
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作者：
LaCourse, Sylvia M.;John-Stewart, Grace;Waldorf, Kristina M. Adams
研究人员正在临床试验设计中采用前所未有的创新，以快速、严格地评估 2019 年冠状病毒病 (COVID-19) 的潜在有前途的疗法；这与将孕妇和哺乳期妇女排除在这些试验之外的近乎普遍的倒退做法形成鲜明对比。少数允许纳入的试验侧重于暴露后预防或较轻疾病的门诊治疗，限制了患有严重 COVID-19 的孕妇的选择，只能同情使用瑞德西韦，或超说明书用药羟氯喹或其他疗法。尽管有孕妇使用这些药物的经验，但仍实施了这些限制。在本观点中，我们呼吁关注现在让孕妇参与 COVID-19 治疗试验的必要性和紧迫性，以便针对这一独特但并不罕见的人群中治疗的风险和益处制定数据驱动的建议。
Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.