Pharmacoethics and pregnancy: Overcoming the therapeutic orphan stigma.
Pharmacoethics and pregnancy: Overcoming the therapeutic orphan stigma.
复制标题
药物伦理学和怀孕：克服治疗孤儿耻辱。
DOI：
10.1111/bcp.15173
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发表时间：
2023
影响因子：
3.4
通讯作者：
Ahmadzia,HomaK
中科院分区：
文献类型：
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作者：
Kazma,JamilM;VanDenAnker,John;Ahmadzia,HomaK
缺乏证据支持与妊娠期药物使用相关的临床决策和咨询。尽管立法机构和倡导团体做出了多项努力，但将孕妇纳入评估疗效和安全性的临床药物试验的情况仍然很少。多种合并症可能会使妊娠变得复杂，需要药物干预；这些干预措施主要针对孕妇，但有时也会对胎儿产生副作用。美国食品和药物管理局发布了多份关于将孕妇纳入临床试验的指导文件，以帮助制药公司设计方案以确保安全并遵守道德标准。儿科药理学研究的进展为研究人员设计纳入特殊人群患者的临床试验的最佳实践提供了经验教训。在这篇综述中，我们介绍了临床试验中孕妇的状况，强调了道德耻辱和未来可能的指示。
There is paucity of evidence to support clinical decision making and counselling related to medication use in pregnancy. Despite multiple efforts from legislative bodies and advocacy groups, the inclusion of pregnant women in clinical drug trials assessing efficacy and safety remains scarce. Pregnancy can be complicated by multiple comorbidities that require pharmacological intervention; these interventions primarily target the pregnant woman but also sometimes have secondary effects for the foetus. The US Food and Drug Administration has issued multiple guidance documents on incorporating pregnant women in clinical trials to aid pharmaceutical companies in designing a protocol to ensure safety and adherence to ethical standards. Advances in paediatric pharmacology studies provide lessons for researchers on the best practice of designing clinical trials with inclusion of patients from special populations. In this review, we present the status of pregnant women in clinical trials, highlighting the ethical stigma and possible future directives.