Fluconazole is a bis-triazole agent used in the treatment of superficial and systemic fungal infections, with vaginal candidiasis being one of the commonest indications to fluconazole treatment. There is increasing concern regarding the teratogenic potential of fluconazole. The aim of this meta-analysis is to pool the literature data in order to evaluate the possible association between fluconazole exposure during pregnancy and birth defects. A total of nine studies were included in the meta-analysis. Results were expressed as odds ratios (OR) with 95 % confidence intervals (CI) and statistical heterogeneity between the studies was evaluated with Higgins index (I²) and Q-test (Q). A p-value < 0.05 referred to the effect was considered statistically significant. The maternal exposure to fluconazole during the first trimester of pregnancy is correlated with increased prevalence of heart defects in the offspring for both low dose (OR 1.95, 95 % CI 1.18–3.21; P = 0.01) and any dose (OR 1.79, 95 % CI 1.18–2.71; P = 0.01). No association was found between gestational exposure to fluconazole and increased risk of spontaneous abortion or stillbirth. Fluconazole should be regarded as a human teratogen and should be cautiously prescribed to pregnant women and to women of childbearing potential.

氟康唑是一种双三唑药物，用于治疗浅表性和全身性真菌感染，阴道念珠菌病是氟康唑治疗的最常见适应症之一。人们越来越关注氟康唑的致畸潜力。本荟萃分析的目的是汇集文献数据，以评估怀孕期间氟康唑暴露与出生缺陷之间可能存在的关联。共有九项研究被纳入荟萃分析。结果以比值比 (OR) 和 95% 置信区间 (CI) 表示，研究之间的统计异质性用希金斯指数 (I ²) 和 Q 检验 (Q)。与效应相关的 p 值 < 0.05 被认为具有统计学意义。对于低剂量 (OR 1.95, 95 % CI 1.18–3.21; P = 0.01) 和任何剂量 (OR 1.79, 95 % CI 1.18–2.71；P = 0.01）。未发现妊娠期氟康唑暴露与自然流产或死产风险增加之间存在关联。氟康唑应被视为一种人类致畸剂，应谨慎用于孕妇和育龄妇女。