Health and Biomedical Innovation, UniSA: Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, Australia.
Centre for Translational Physiology & Department of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.
J Dev Orig Health Dis. 2022 Feb;13(1):9-19. doi: 10.1017/S2040174420001403. Epub 2021 Jan 25.
Medical care is predicated on 'do no harm', yet the urgency to find drugs and vaccines to treat or prevent COVID-19 has led to an extraordinary effort to develop and test new therapies. Whilst this is an essential cornerstone of a united global response to the COVID-19 pandemic, the absolute requirements for meticulous efficacy and safety data remain. This is especially pertinent to the needs of pregnant women; a group traditionally poorly represented in drug trials, yet a group at heightened risk of unintended adverse materno-fetal consequences due to the unique physiology of pregnancy and the life course implications of fetal or neonatal drug exposure. However, due to the complexities of drug trial participation when pregnant (be they vaccines or therapeutics for acute disease), many clinical drug trials will exclude them. Clinicians must determine the best course of drug treatment with a dearth of evidence from either clinical or preclinical studies, where at least in the short term they may be more focused on the outcome of the mother than of her offspring.
医疗保健的前提是“不造成伤害”，然而，为了寻找治疗或预防 COVID-19 的药物和疫苗，人们已经竭尽全力开发和测试新的疗法。虽然这是全球应对 COVID-19 大流行的必要基石，但对细致的疗效和安全性数据的绝对要求仍然存在。这对于孕妇的需求尤为重要；这是一个在药物试验中代表性不足的群体，但由于怀孕的独特生理和胎儿或新生儿药物暴露对生命过程的影响，她们处于更高的意外母婴不良后果风险之中。然而，由于怀孕期间参与药物试验的复杂性（无论是针对急性疾病的疫苗还是治疗药物），许多临床药物试验都会将其排除在外。临床医生必须在缺乏临床或临床前研究证据的情况下确定最佳药物治疗方案，至少在短期内，他们可能更关注母亲的结局，而不是她的后代。
