在试验期间对全球怀孕妇女进行的研究

S. Chaudhry, V. Sovani
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引用次数: 0

摘要

临床研究的目的是传授能够改善人类健康或增进对人体生理学的了解的知识。尽管直到20世纪末,妊娠一直处于排除标准之下,但目前在临床试验中普遍排除孕妇是不合理的。怀孕带来了一系列的解剖、生理和生化变化,这些变化会影响重要药物的药代动力学。怀孕常常伴有慢性疾病,如糖尿病、高血压、肺结核、艾滋病毒、抑郁症,这些疾病需要长期治疗。这表明有必要专门对孕妇进行研究。目前的交流叙述了在临床试验中纳入孕妇的伦理和监管方面。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Research conducted on gestating women globally during trials
The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.
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