Stock Sarah Je, Norman Jane E
Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, UK.
MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh BioQuarter, Edinburgh, EH16 4SA, UK.
F1000Res. 2019 Jun 20;8. doi: 10.12688/f1000research.17535.1. eCollection 2019.
Medicine use in pregnancy is extremely common, but there are significant knowledge gaps surrounding the safety, dosage and long-term effects of drugs used. Pregnant women have been purposively excluded from clinical trials of the majority of treatments for conditions that may occur concurrently with pregnancy. There is minimal information on the pharmacokinetics of many existing treatments and no systematic capture of long-term outcome data to help inform choices. Treatments commonly used in pregnancy are thus often old and untested, not optimised in dose, and prescribed off-label without adequate safety information. In addition, there has been a staggering lack of investment in drug development for obstetric conditions for decades. This is a major public health concern, and pregnancy complications are the leading cause of mortality in children under five years old globally, and health in pregnancy is a major determinant of women's long-term health and wellbeing. There is an acute need for adequate investment and legislation to boost inclusion of pregnant women in clinical studies, capture high-quality information on medication use in pregnancy in general, and encourage new medicinal product development for obstetric conditions.
孕期用药极为普遍,但在所用药物的安全性、剂量及长期影响方面存在重大知识空白。大多数针对可能与妊娠同时出现的病症的治疗方法,在临床试验中都特意将孕妇排除在外。对于许多现有治疗方法的药代动力学信息极少,也没有系统收集长期结局数据以辅助决策。因此,孕期常用的治疗方法往往陈旧且未经测试,剂量未优化,且在没有充分安全信息的情况下超说明书用药。此外,几十年来,用于产科病症的药物研发投入严重不足。这是一个重大的公共卫生问题,妊娠并发症是全球五岁以下儿童死亡的主要原因,孕期健康是女性长期健康和幸福的主要决定因素。迫切需要进行充分的投资和立法,以促进将孕妇纳入临床研究,全面收集关于孕期用药的高质量信息,并鼓励开发用于产科病症的新药。