Benevent Justine, Araujo Mélanie, Beau Anna-Belle, Sicard Diane, Sommet Agnès, Hurault-Delarue Caroline, Lacroix Isabelle, Damase-Michel Christine
Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique, Toulouse University Hospital (CHU de Toulouse), 37 Allées Jules Guesde, 31000, Toulouse, France.
Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital), Toulouse, France.
Infection. 2023 Feb;51(1):137-146. doi: 10.1007/s15010-022-01861-4. Epub 2022 Jun 11.
Fosfomycin trometamol has been recommended as first-line bactericidal antibiotic for urinary tract infections in pregnant women since 2015 in France. However, studies assessing fosfomycin safety in pregnancy are sparse. This study aimed to assess the risk of major Congenital Anomaly (CA) after fosfomycin exposure during the first trimester of pregnancy.
We performed a comparative study in EFEMERIS, the French database including expecting mothers covered by the French Health Insurance System of Haute-Garonne from July 1st, 2004 to December 31th, 2018. EFEMERIS contains prescribed and dispensed reimbursed medications during pregnancy and pregnancy outcomes. Logistic regressions have been conducted to compare three groups: (1) pregnancies exposed at least once to fosfomycin; (2) pregnancies exposed at least once to nitrofurantoin; and (3) pregnancies exposed neither to fosfomycin nor to nitrofurantoin, another antibiotic prescribed for urinary infections, before and during pregnancy.
A total of 2724 (2.0%) pregnant women received at least one fosfomycin prescription during the first trimester, 650 (0.5%) received nitrofurantoin during the first trimester, and 133,502 (97.5%) pregnant women were not exposed to fosfomycin nor to nitrofurantoin. First trimester pregnancy exposure to fosfomycin was not associated with an increased risk of major CA, compared to first trimester exposure to nitrofurantoin (2.0% versus 2.5%; OR = 0.80 [0.44-1.47]), or to pregnancies unexposed to fosfomycin and nitrofurantoin (2.0% versus 2.1%; OR = 0.97 [0.73-1.30]).
This is the first large comparative study assessing fosfomycin safety in pregnancy. It does not exhibit an increased risk of major CA after fosfomycin exposure during the first trimester of pregnancy.
自2015年起，磷霉素氨丁三醇在法国被推荐为孕妇尿路感染的一线杀菌抗生素。然而，评估磷霉素在孕期安全性的研究较少。本研究旨在评估妊娠早期暴露于磷霉素后出现重大先天性异常（CA）的风险。
我们在EFEMERIS中进行了一项比较研究，该法国数据库涵盖了2004年7月1日至2018年12月31日期间法国上加龙省医疗保险系统覆盖的准妈妈。EFEMERIS包含孕期开具和配发的报销药物以及妊娠结局。进行了逻辑回归以比较三组：（1）至少一次暴露于磷霉素的妊娠；（2）至少一次暴露于呋喃妥因的妊娠；（3）在妊娠前及妊娠期间既未暴露于磷霉素也未暴露于呋喃妥因（另一种用于治疗尿路感染的抗生素）的妊娠。
共有2724名（2.0%）孕妇在妊娠早期接受了至少一次磷霉素处方，650名（0.5%）孕妇在妊娠早期接受了呋喃妥因，133502名（97.5%）孕妇既未暴露于磷霉素也未暴露于呋喃妥因。与妊娠早期暴露于呋喃妥因（2.0%对2.5%；OR = 0.80 [0.44 - 1.47]）或未暴露于磷霉素和呋喃妥因的妊娠（2.0%对2.1%；OR = 0.97 [0.73 - 1.30]）相比，妊娠早期暴露于磷霉素与重大CA风险增加无关。
这是第一项评估磷霉素在孕期安全性的大型比较研究。它未显示妊娠早期暴露于磷霉素后重大CA风险增加。
