Association of Quinolone Exposure in the First-Trimester of Pregnancy and the Risk of Major Congenital Malformations: A Health Administrative Database Study in Japan.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-09-01 DOI:10.1002/pds.70190

Kei Morishita, Taku Obara, Tomofumi Ishikawa, Ryo Obara, Takamasa Sakai, Noriyuki Iwama, Genki Shinoda, Aoi Noda, Masatsugu Orui, Mami Ishikuro, Hiroshi Kawame, Nariyasu Mano, Shinichi Kuriyama

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引用次数: 0

Abstract

Purpose: To evaluate the risk of major congenital malformations (MCMs) associated with quinolone exposure during the first trimester of pregnancy using a large administrative database in Japan.

Methods: A large claims database was used from January 2005 to November 2019. The dates of pregnancy onset and delivery were estimated using the developed algorithm. MCMs were defined according to the International Classification of Diseases, 10th revision codes. The risk of MCM associated with first-trimester quinolone prescriptions was evaluated in women with infectious diseases diagnosed during the first trimester of pregnancy. We evaluated the overall risk of MCMs in infants, and odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by comparing women with first-trimester prescriptions of quinolones with those without antibiotic prescriptions, adjusting for covariates with propensity score overlap weights.

Results: The prevalence of first-trimester infectious diseases was 51.6% (47 121/91390). Among 47 121 women diagnosed with infectious diseases, 1 320 were prescribed quinolones during their first trimester of pregnancy. The overall prevalence of MCMs was 6.0% (2282/37766) in women unexposed to antibiotics and 5.9% (78/1320) in those exposed to quinolones. The first-trimester prescription of quinolone was not significantly associated with the overall MCM prevalence when overlap-weighted ORs (wOR) were calculated using propensity score overlap weights for covariates (wOR 0.904, 95% CIs 0.684-1.196).

Conclusions: Prescription of quinolones in the first-trimester of pregnancy was not associated with an increased risk of MCMs in infants. Our findings may support clinical decision-making when considering quinolone use during the first-trimester of pregnancy.

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妊娠前三个月喹诺酮暴露与重大先天性畸形风险的关系：日本卫生管理数据库研究

目的：利用日本的一个大型管理数据库，评估与妊娠前三个月喹诺酮暴露相关的重大先天性畸形（mcm）的风险。方法：使用2005年1月至2019年11月的大型理赔数据库。使用开发的算法估计怀孕开始和分娩日期。mcm是根据《国际疾病分类》第10次修订代码定义的。在怀孕前三个月诊断患有传染病的妇女中，评估了与妊娠早期喹诺酮处方相关的MCM风险。我们评估了婴儿mcm的总体风险，并通过比较妊娠早期服用喹诺酮类药物的妇女与未服用抗生素的妇女，调整倾向评分重叠权重的协变量，估计了优势比（ORs）和95%置信区间（CIs）。结果：妊娠早期感染性疾病患病率为51.6%（47 121/91390）。在47 121名被诊断患有传染病的妇女中，有1 320人在怀孕前三个月服用了喹诺酮类药物。未暴露于抗生素的妇女mcm的总体患病率为6.0%(2282/37766)，而暴露于喹诺酮类药物的妇女mcm的总体患病率为5.9%（78/1320）。当使用协变量的倾向评分重叠权重计算重叠加权or （wOR）时，妊娠早期喹诺酮处方与MCM总体患病率无显著相关性（wOR 0.904, 95% ci 0.684-1.196）。结论：妊娠早期开具喹诺酮类药物与婴儿mcm风险增加无关。我们的发现可能支持临床决策时，考虑在妊娠早期使用喹诺酮类药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.