Pharmacoepidemiology Research Unit, Division of Clinical Pharmacy Institute for Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, Jerusalem, Israel.
Pharm Res. 2018 Mar 26;35(5):109. doi: 10.1007/s11095-018-2383-8.
Quinolones, and the fluoroquinolones subgroup, are a class of antibiotics commonly used for the treatment of a wide variety of infections. However, their safety profile in pregnant women is controversial. The association between fluoroquinolones and arthropathy was primarily described in immature animals, and only rarely in humans, yet it has led to the restricted use of quinolones during pregnancy. We aimed to assess their safety during pregnancy.
A systematic review and meta-analysis assessing the safety of quinolone exposure during any time of pregnancy, and during first trimester alone, was performed. The systematic review was performed using MEDLINE and EMBASE, and followed the PRISMA guidelines. Pooled effect sizes with corresponding 95% confidence intervals (CI) were calculated using random effects models, comparing fetal outcomes of quinolone exposed and non-exposed pregnancies. Only cohort and case control studies were included in the meta-analysis.
Twelve studies met the inclusion criteria. Exposure to quinolones during first trimester was not associated with an increased risk for birth defects (pooled odds ratio (OR) = 0.89, 95% CI 0.72-1.09, I = 0%), stillbirth (OR = 1.32, 95% CI 0.33-5.34, I = 16%), preterm birth (OR = 1.10, 95% CI 0.83-1.48, I = 41%) and low birth weight (OR = 1.29, 95% CI 0.54-3.12, I = 67%).
The use of quinolones during the first-trimester of pregnancy was not associated with an increased risk of birth defects, stillbirths, preterm births or low birth weight.
PROSPERO CRD42017060573.
喹诺酮类药物和氟喹诺酮类药物亚组是一类常用于治疗多种感染的抗生素。然而，其在孕妇中的安全性仍存在争议。氟喹诺酮类药物与关节病的关联主要在未成熟动物中描述，在人类中很少见，但这导致了怀孕期间限制使用喹诺酮类药物。我们旨在评估其在怀孕期间的安全性。
我们进行了一项系统评价和荟萃分析，评估了在任何孕期以及仅在孕早期使用喹诺酮类药物的安全性。该系统评价使用 MEDLINE 和 EMBASE 进行，并遵循 PRISMA 指南。使用随机效应模型计算具有相应 95%置信区间（CI）的汇总效应大小，比较暴露于喹诺酮类药物的妊娠和未暴露于喹诺酮类药物的妊娠的胎儿结局。仅纳入队列研究和病例对照研究进行荟萃分析。
符合纳入标准的有 12 项研究。在孕早期暴露于喹诺酮类药物与出生缺陷风险增加无关（汇总比值比（OR）=0.89，95%CI 0.72-1.09，I²=0%）、死胎（OR=1.32，95%CI 0.33-5.34，I²=16%）、早产（OR=1.10，95%CI 0.83-1.48，I²=41%）和低出生体重（OR=1.29，95%CI 0.54-3.12，I²=67%）。
在孕早期使用喹诺酮类药物与出生缺陷、死胎、早产或低出生体重的风险增加无关。
PROSPERO CRD42017060573。
