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孕期抗生素安全性综述——2025年更新

A review of antibiotic safety in pregnancy-2025 update.

作者信息

Nguyen Johny, Madonia Victoria, Bland Christopher M, Stover Kayla R, Eiland Lea S, Keating Julia, Lemmon Madeline, Bookstaver P Brandon

机构信息

University of South Carolina College of Pharmacy, Columbia, South Carolina, USA.

University of Georgia College of Pharmacy, Savannah, Georgia, USA.

出版信息

Pharmacotherapy. 2025 Apr;45(4):227-237. doi: 10.1002/phar.70010. Epub 2025 Mar 19.

Abstract

Antibiotics constitute the majority of prescriptions for women during pregnancy. Common bacterial infections, including urinary tract infections, skin and soft tissue infections, and upper and lower respiratory tract infections, are expected in pregnancy, similar to the general public. These infections carry additional risks to both the woman and fetus; thus, antibiotics are often prescribed. Antibiotics, like other drugs, are not benign and may carry additional risks to the fetus beyond commonly encountered adverse drug events seen across most patient populations. Since 2014, 19 new antibiotics have been approved by the United States Food and Drug Administration. Additionally, in 2018, the previously held pregnancy category rating expired, and all manufacturers' labeling was updated with new narrative language reflecting safety in pregnancy, lactation, and males and females of reproductive potential. This review provides a comprehensive summary of available data and an update to the 2015 publication regarding the safe use of antibiotics in pregnancy. The primary focus of this review is on newly approved antibiotics, along with any additional published evidence on previously reviewed antibiotics. Data on lactation or antiviral or antifungal use in pregnancy are not included. Clinicians should remain updated on current available evidence and vigilant to provide safe and effective antibiotic decision-making in pregnant women.

摘要

抗生素是孕期女性处方用药的主要组成部分。与普通人群一样,孕期常见的细菌感染包括尿路感染、皮肤及软组织感染以及上、下呼吸道感染。这些感染对孕妇和胎儿都会带来额外风险,因此常需开具抗生素处方。抗生素与其他药物一样并非无害,除了大多数患者群体常见的药物不良事件外,还可能给胎儿带来其他风险。自2014年以来,美国食品药品监督管理局已批准了19种新型抗生素。此外,2018年,以前的妊娠用药分级制度失效,所有药品生产商的药品标签都更新为新的叙述性文字,反映了药物在孕期、哺乳期以及有生殖潜力的男性和女性中的安全性。本综述全面总结了现有数据,并对2015年发表的关于孕期安全使用抗生素的文献进行了更新。本综述的主要重点是新批准的抗生素,以及之前已审查抗生素的任何其他已发表证据。不包括关于哺乳期或孕期使用抗病毒或抗真菌药物的数据。临床医生应及时了解当前可用的证据,并保持警惕,以便为孕妇提供安全有效的抗生素治疗决策。

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