一个基于人口的队列来评估怀孕期间的药物安全性 (普雷格瓦尔):理由,设计和基线特征
Francisco Sánchez-Sáez1,2,3, Gabriel Sanfélix-Gimeno1,2, Isabel Hurtado1,2
1Health Services Research and Pharmacoepidemiology Unit, FISABIO, Valencia, Spain.
European journal of epidemiology
|June 23, 2025
概括
普雷格瓦尔队列研究监测了孕妇的药物安全性,这对于了解子宫内药物效应至关重要. 这项大型的西班牙研究提供了关于怀孕结果和药物暴露的真实数据.
科学领域:
- 药物监督 药物监督 药物监督
- 生殖流行病学 生殖流行病学
- 公共卫生 公共卫生
背景情况:
- 孕妇经常被排除在药物临床试验之外,限制了对子宫内药物安全性的知识.
- 在怀孕期间评估药物安全性对于母亲和胎儿的健康至关重要.
- 现有注册表可能会遭受错误分类,需要可靠的数据来源.
研究的目的:
- 评估和监测给孕妇使用的药物的子宫内安全性.
- 建立一个大规模的,基于人口的队列,进行全面的怀孕和药物安全研究.
- 提供关于怀孕期间药物使用安全性的真实证据.
主要方法:
- 普雷格瓦尔队列包括瓦伦西亚地区 (西班牙) 的超过52万例怀孕,2009-2021.
- 使用瓦伦西亚综合数据库 (VID) 进行个人级数据链接,包括并发病,社会人口统计和详细的药物暴露.
- 随访从怀孕前延伸到长期的产后结果,捕捉妊娠并发症,分娩结果和先天异常.
主要成果:
- 普雷格瓦尔队列是迄今为止评估子宫内药物安全性的最大和最详尽的队列之一.
- 研究设计通过详细的处方和发行数据,尽量减少暴露错误分类.
- 有关于怀孕结果和长期随访的全面数据可用.
结论:
- 普雷格瓦尔队列为现实世界的子宫内药物安全性评估提供了独特而强大的资源.
- 这项研究将为了解怀孕期间使用的药物的安全性概况做出重大贡献.
- 调查结果将为临床实践和有关孕妇药物使用的监管决策提供信息.
相关概念视频
01:19Pharmacovigilance
1.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.0K
01:28Preclinical Development: Overview
4.9K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.9K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
184
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
184
01:25Drug Regulation
1.9K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.9K
01:11Clinical Trials: Overview
3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K
01:12Analysis of Population Pharmacokinetic Data
397
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
397