Specific birth defects and asthma medications in pregnancy: Demonstration project

妊娠期特定出生缺陷和哮喘药物：示范项目

• 批准号: 8105480
• 负责人: ALLEN A MITCHELL
• 金额: $ 49.15万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8105480
• 关键词: Specific; birth; defects; asthma; medications

DESCRIPTION (provided by applicant): Recognition of the comparative effectiveness of medications has profound implications for both rational and cost-effective therapeutics, but without knowing the comparative risks of medications, benefit-risk estimates are necessarily incomplete. Unique among any other treated population, risks among pregnant women relate not just to the patient (the pregnant woman), but also to the fetus. Because premarketing studies don't and can't provide meaningful risk data, this task falls to the post marketing setting. Though the debacle of thalidomide in the early 1960s identified the devastating potential of medications to cause birth defects, more than four decades later there is no system in place to comprehensively assess the pregnancy safety of even relatively commonly used medications. Asthma is the most common chronic condition requiring medication treatment in pregnancy, yet we know little about the risks to the fetus of current and newly introduced asthma medications. Using an established case control surveillance study of specific drug exposures in relation to specific birth defects (the Slone Epidemiology Center Birth Defects Study, BDS), we seek to demonstrate its ability to assess, in a systematic, efficient, and valid manner, the risks and safety of various asthma medications in relation to specific birth defects. In addition to capturing information on actual use of medications (including prescription, over-the counter, and herbals) and validating birth defects through medical record review, this study will use a validated questionnaire to assess asthma control and capture information on important confounders-such as smoking and periconceptional folate consumption-that are critical to the consideration of birth defects. Further, the project will work closely with the OTIS Pregnancy Registries and the American Academy of Asthma, Allergy, and Immunology (AAAAI) to demonstrate the feasibility and value of the Asthma and Allergy Medications in Pregnancy Safety Surveillance (AAMPSS) approach, a collaborative system involving two complementary data collection methods (BDS case-control surveillance and OTIS pregnancy registries) combined into a common infrastructure that includes an Independent Advisory Committee (to be coordinated by the AAAAI). The success of this demonstration project will lead to an ongoing, comprehensive, and valid system to assess the fetal risks associated with the wide range of medications (beyond asthma), and will permit comparative effectiveness measures to finally include critically important information on the risks and safety of medications taken by pregnant women.

描述（由申请人提供）：认识到药物的相对有效性对于合理且具有成本效益的治疗具有深远的影响，但如果不了解药物的相对风险，效益-风险估计必然是不完整的。与其他接受治疗的人群不同，孕妇的风险不仅与患者（孕妇）有关，还与胎儿有关。由于上市前研究不会也无法提供有意义的风险数据，因此这项任务落到了上市后环境中。尽管沙利度胺在 20 世纪 60 年代初的惨败表明药物具有导致出生缺陷的破坏性潜力，但四十多年后，仍然没有任何系统可以全面评估即使是相对常用的药物的妊娠安全性。哮喘是妊娠期最常见的需要药物治疗的慢性疾病，但我们对当前和新引入的哮喘药物对胎儿的风险知之甚少。利用已建立的针对与特定出生缺陷相关的特定药物暴露的病例对照监测研究（斯隆流行病学中心出生缺陷研究，BDS），我们试图证明其能够以系统、高效和有效的方式评估各种哮喘药物与特定出生缺陷相关的风险和安全性。除了获取有关实际使用药物（包括处方药、非处方药和草药）的信息以及通过病历审查验证出生缺陷之外，本研究还将使用经过验证的问卷来评估哮喘控制并获取对于考虑出生缺陷至关重要的重要混杂因素（例如吸烟和围孕期叶酸摄入量）的信息。此外，该项目将与奥的斯妊娠登记处和美国哮喘、过敏和免疫学学会 (AAAAI) 密切合作，展示妊娠期哮喘和过敏药物安全监测 (AAMPSS) 方法的可行性和价值，该方法是一个协作系统，涉及两种互补的数据收集方法（BDS 病例对照监测和奥的斯妊娠登记处）， 包括独立咨询委员会（由 AAAAI 协调）的公共基础设施。该示范项目的成功将导致建立一个持续、全面和有效的系统来评估与各种药物（哮喘以外）相关的胎儿风险，并将允许比较有效性措施最终包括有关孕妇服用药物的风险和安全性的至关重要的信息。