孕期药物暴露与不良妊娠结局:流行病学分析与安全性评估  

Drug use during pregnancy and adverse pregnancy outcomes:Epidemiological analysis and safety assessment

作　　者：刘雯雨 肖晚晴 邱琇 Liu Wenyu#;Xiao Wanqing#;Qiu Xiu*(Guangzhou Women and Children's Medical Center,Guangzhou Medical University,Guangzhou 510623,Guangdong,China)

机构地区：[1]广州医科大学附属妇女儿童医疗中心,广东广州510623

出　　处：《生物医学转化》2025年第1期10-19,共10页Biomedical Transformation

基　　金：国家自然科学基金面上项目(82173525);国家自然科学基金青年基金项目(42207496);广东省基础与应用基础研究基金省市联合基金重点项目(2022B1515120080);广州市卫生健康科技重大项目(2023A031001);广州市科学技术局基础与应用基础研究项目(2024A03J1104)。

摘　　要：孕期药物使用普遍存在,但孕期药物使用安全性证据仍不足。多数新药缺乏妊娠安全数据,中药/中成药使用率激增但机制不明,药物联合使用率高而相关风险不清。本文总结了现有药物调查方法的优势与偏倚;阐述了孕激素、抗生素、解热镇痛药、精神类药物、中药/中成药等在孕期使用的流行病学特征与地域差异以及药物联用情况;讨论了单药及药物联用对多种不良结局的影响;阐明了药物联用对妊娠结局作用的潜在机制;并探讨国际妊娠用药分级体系的冲突与局限性。厘清孕期单药与多药使用对出生结局的影响及潜在机制,对本土化妊娠用药风险评估框架建设、多药协同暴露防控策略制定及临床精准用药决策具有重要意义。Drug use during pregnancy is highly prevalent,but evidence on the safety of such use remains limited.Most newly approved drugs lack sufficient safety data for pregnancy,and the use of traditional Chinese medicines/Chinese patent medicines has surged despite unclear mechanisms.Additionally,the high prevalence of polypharmacy during pregnancy is accompanied by unclear associated risks.This review systematically summarizes the advantages and limitations of current methods for investigating drug use.It provides a comprehensive overview of the epidemiological characteristics,regional variations,and polypharmacy patterns in the use of progestogens,antibiotics,antipyretics and analgesics,psychotropic drugs,and traditional Chinese medicines/Chinese patent medicines during pregnancy.Moreover,it discusses the effects of single-drug and polypharmacy exposure on adverse birth outcomes,elucidates the potential mechanisms underlying the effect of polypharmacy on pregnancy outcomes,and explores the conflicts and limitations of international pregnancy drug classification systems.Understanding the effects and mechanisms of single-drug and polypharmacy exposure on birth outcomes is crucial for establishing a localized risk assessment framework for drug use during pregnancy,developing strategies for the prevention and control of polypharmacy exposure,and supporting evidence-based clinical decision-making for precision drug use during pregnancy.

关 键 词：药物暴露 妊娠结局 药物监管 孕期 

分 类 号：R114[医药卫生—卫生毒理学]