孕期药物暴露与出生缺陷相关性研究的横断面调查  

A survey of studies investigating the association between medication exposure during pregnancy and birth defects

作　　者：王晶[1,2,3] 李明曦 刘春容 熊益权 齐亚娜 谭婧 孙鑫[1,2,3] WANG Jing;LI Mingxi;LIU Chunrong;XIONG Yiquan;QI Yana;TAN Jing;SUN Xin(Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan,Chengdu 610041,P.R.China;Sichuan Center of Technology Innovation for Real World Data,Chengdu 610041,P.R.China)

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]国家药品监督管理局海南真实世界数据研究与评价重点实验室,成都610041 [3]四川省真实世界数据技术创新中心,成都610041

出　　处：《中国循证医学杂志》2022年第6期692-705,共14页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:72174132、71974138、72004148);四川省青年科技创新研究团队(编号:2020JDTD0015);美国中华医学基金会项目(编号:CMB19-324)。

摘　　要：目的 对孕期药品暴露和出生缺陷相关性研究进行调查,以期为提高孕期用药安全性相关研究的质量提供参考。方法 计算机检索Pub Med数据库,搜集孕期用药与出生缺陷相关性的观察性研究,检索时限从2020年1月1日到2020年12月31日。由2位研究者独立筛选文献和提取资料后,采用R 3.6.1软件进行统计分析。结果 共纳入40篇文献。8个研究(20.0%)发表在医学四大刊及其子刊中,21个研究(42.5%)来自欧美国家,来自中国的研究有4个(10.0%)。主要研究设计为队列研究(30,75.0%)和病例-对照研究(10,25.0%)。16个研究(40.0%)未说明数据库之间的链接方式。16个研究(40.0%)未报告明确的暴露定义,17个研究(42.5%)将暴露定义为某处方药物,但无法保证孕妇确实服用了该研究药物,可能造成错分偏倚;6个研究(15.0%)未报告出生缺陷的诊断标准,18个研究(45.0%)未具体报告出生缺陷的具体类型;33个研究(82.5%)未在研究设计阶段控制混杂因素,且仅19个研究(47.5%)考虑了活产偏倚。结论 现有妊娠期药物暴露和出生缺陷相关性研究在数据来源、暴露和结局的定义及混杂因素的控制等方面均存在较多的方法学不足,亟需制订相关的技术规范来指导相关研究,为决策者和研究者提供更高质量的研究证据。Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The Pub Med database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which8(20.0%) were published in the four major medical journals and their sub-journals, 21(42.5%) were conducted in Europe and the United States, and 4 were conducted(10.0%) in China. Cohort studies(30, 75.0%) and case-control studies(10,25%) were the most commonly used study designs. Sixteen studies(40.0%) did not specify how the databases were linked.Sixteen studies(40.0%) did not report a clear definition of exposure, while 17 studies(42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies(15.0%) did not report the diagnostic criteria for birth defects and 18 studies(45.0%) did not report the types of birth defects. In addition, 33 studies(82.5%) did not control for confounding factors in the study design, while only 19 studies(47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors.Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.

关 键 词：孕妇 药品 出生缺陷 观察性研究 方法学 

分 类 号：R715.3[医药卫生—妇产科学]