Pregnancy outcomes after first-trimester exposure to fluoroquinolones: Findings based on an integrated database from two Japanese institutions

IF 1.3 4区 医学 Q3 PEDIATRICS
Mikako Goto, Tatsuhiko Anzai, Ritsuko Yamane, Naho Yakuwa, Kunihiko Takahashi, Atsuko Murashima
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Abstract

Given the paucity of safety data on fluoroquinolone antibiotics in pregnancy, a prospective observational cohort study was conducted in pregnant women who sought help and advice on drug use at two teratology information institutes in Japan. The primary endpoint of the study was the incidence of major congenital anomalies. The study population included pregnant women exposed to (i) fluoroquinolones (fluoroquinolone group), (ii) β-lactams (infectious control group), or (iii) other agents considered to be nonteratogenic in humans (nonteratogenic control group) during the first trimester. The frequency of major congenital anomalies was compared across groups using a logistic regression model that adjusted for maternal age, smoking status, drinking status, facility consulted, and time of consultation. The fluoroquinolone group consisted of 411 women who had 383 children born alive. The infectious control and nonteratogenic control groups consisted of 1416 and 1482 women who had 1322 and 1401 children born alive, respectively. The incidence of major congenital anomalies was 1.5%, 2.0%, and 1.6% in the fluoroquinolone group, infectious control, and nonteratogenic control groups, respectively. Logistic regression showed that fluoroquinolone exposure is not a significant risk factor for major congenital anomalies. In conclusion, first-trimester exposure to fluoroquinolone antibiotics was not associated with increased maternal or fetal risks.

Abstract Image

第一孕期接触氟喹诺酮类药物后的妊娠结局:根据日本两家医疗机构的综合数据库得出的结论。
鉴于有关妊娠期使用氟喹诺酮类抗生素的安全性数据极少,我们对在日本两家畸形儿信息机构寻求用药帮助和建议的孕妇进行了一项前瞻性观察性队列研究。研究的主要终点是重大先天性畸形的发生率。研究对象包括在妊娠头三个月接触过(i)氟喹诺酮类药物(氟喹诺酮组)、(ii)β-内酰胺类药物(感染对照组)或(iii)其他被认为对人体无致畸作用的药物(无致畸作用对照组)的孕妇。采用逻辑回归模型比较了各组重大先天性畸形的发生频率,该模型对产妇年龄、吸烟状况、饮酒状况、就诊机构和就诊时间进行了调整。氟喹诺酮类药物组有 411 名产妇,其中 383 名活产儿。感染对照组和非致畸对照组分别由 1416 名和 1482 名产妇组成,她们的活产婴儿分别为 1322 名和 1401 名。氟喹诺酮组、感染对照组和非致畸对照组的重大先天畸形发生率分别为1.5%、2.0%和1.6%。逻辑回归结果显示,氟喹诺酮类药物暴露并不是重大先天性畸形的重要风险因素。总之,孕期首次接触氟喹诺酮类抗生素不会增加母体或胎儿的风险。
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来源期刊
Congenital Anomalies
Congenital Anomalies PEDIATRICS-
自引率
0.00%
发文量
49
审稿时长
>12 weeks
期刊介绍: Congenital Anomalies is the official English language journal of the Japanese Teratology Society, and publishes original articles in laboratory as well as clinical research in all areas of abnormal development and related fields, from all over the world. Although contributions by members of the teratology societies affiliated with The International Federation of Teratology Societies are given priority, contributions from non-members are welcomed.
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