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药物流行病学在孕期的重要性——对安全性的影响

The importance of pharmacoepidemiology in pregnancy-implications for safety.

作者信息

Benevent Justine, Montastruc Francois, Damase-Michel Christine

机构信息

a Faculté de Médecine , Université Toulouse III, CRPV Midi-Pyrénées, CHU Toulouse, UMR INSERM 1027/CIC 1436 , Toulouse , France.

出版信息

Expert Opin Drug Saf. 2017 Oct;16(10):1181-1190. doi: 10.1080/14740338.2017.1363177. Epub 2017 Aug 10.


DOI:10.1080/14740338.2017.1363177
PMID:28777918
Abstract

Prescription of medications to pregnant women is usually a challenge as the drug benefit has to be considered regarding its potential adverse effects. As medication use is common in pregnant women, by chance or necessity, it gives the opportunity to evaluate the consequences of prenatal drug exposure in real life through pharmacoepidemiologic studies. Area covered: Data sources are numerous. Some of them have been created for the particular purpose of assessing medications during pregnancy. Augmented databases enable the study of delayed effects in late childhood and provide information on potential confounders. Each data source exhibits strengths and weaknesses. Several designs can be used to assess the safety of medications during pregnancy. Innovative designs have been developed in order to bypass major limits of classical methods. Expert opinion: An efficient system could follow up each pregnant woman, who had taken a medication, and consider her as a precious information for the knowledge of drug potential adverse actions against the child, who must be followed up to identify long term-effects. The diversity of data sources and approaches of pharmacoepidemiologic studies, the implementation of international networks as well as the improvement of adverse signal detection are the keystones of such an evaluation.

摘要

给孕妇开药通常是一项挑战,因为必须在考虑药物益处的同时兼顾其潜在的不良反应。由于孕妇用药无论是出于偶然还是必要都很常见,这就为通过药物流行病学研究在现实生活中评估产前药物暴露的后果提供了机会。涵盖领域:数据来源众多。其中一些是专门为评估孕期用药而创建的。扩充后的数据库有助于研究儿童晚期的延迟效应,并提供有关潜在混杂因素的信息。每个数据来源都有其优缺点。有几种设计可用于评估孕期用药的安全性。为了克服传统方法的主要局限性,已经开发出了创新设计。专家意见:一个有效的系统可以对每位服用过药物的孕妇进行跟踪,并将她视为了解药物对儿童潜在不良作用的宝贵信息来源,必须对儿童进行跟踪以确定长期影响。药物流行病学研究的数据来源和方法的多样性、国际网络的建立以及不良信号检测的改进是此类评估的关键所在。

相似文献

[1]
The importance of pharmacoepidemiology in pregnancy-implications for safety.

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[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources-A Contribution of the ConcePTION Project.

Pharmacoepidemiol Drug Saf. 2025-7

[2]
The maternal drug exposure birth cohort (DEBC) in China.

Nat Commun. 2024-6-21

[3]
Placental efflux transporters and antiseizure or antidepressant medication use impact birth weight in MoBa cohort.

iScience. 2024-2-20

[4]
Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION.

J Pregnancy. 2024

[5]
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project.

Drug Saf. 2024-3

[6]
Safety surveillance for PrEP in pregnant and breastfeeding women.

Front Reprod Health. 2023-9-29

[7]
Pharmacoepidemiology and costs of medications dispensed during pregnancy: A retrospective population-based study.

BJOG. 2023-10

[8]
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports.

Ann Rheum Dis. 2023-2

[9]
Identifying Barriers to Enrollment in Patient Pregnancy Registries: Building Evidence Through Crowdsourcing.

JMIR Form Res. 2022-5-25

[10]
Racial/Ethnic Differences in Prenatal Supplement and Medication Use in Low-Risk Pregnant Women.

Am J Perinatol. 2022-4

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