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.
摘要：
鉴于妊娠期氟喹诺酮类抗生素的安全性数据较少，我们对在日本两个畸形学信息研究所寻求药物使用帮助和建议的孕妇进行了前瞻性观察性队列研究.研究的主要终点是主要先天性异常的发生率。研究人群包括暴露于（i）氟喹诺酮类药物（氟喹诺酮类药物组）的孕妇，(ii)β-内酰胺类（感染对照组），或（iii）在妊娠早期被认为是人类非致畸药物（非致畸对照组）。使用逻辑回归模型对主要先天性异常的频率进行了比较，该模型针对产妇年龄进行了调整，吸烟状况,饮酒状况,咨询了设施，和咨询时间。氟喹诺酮组由411名妇女组成，她们有383个活着出生的孩子。感染对照组和非致畸对照组由1416和1482名妇女组成，这些妇女有1322和1401个活产的孩子，分别。主要先天性畸形的发生率为1.5%,2.0%,和1.6%的氟喹诺酮组，传染病控制,和非致畸对照组，分别。Logistic回归分析显示，氟喹诺酮暴露不是主要先天性畸形的重要危险因素。总之,妊娠早期暴露于氟喹诺酮类抗生素与孕妇或胎儿风险增加无关.
