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Fluconazole: teratogenic, even with as little as just one 150 mg dose

机译:氟康唑:致畸,即使只有150 mg剂量

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A large-scale cohort study based on reimbursement data in the United States compared malformations in infants after exposure during the first trimester of pregnancy, either to oral fluconazole (at least one dose of 150 mg; about 40 000 women) or to a topical antifungal (about 80 000 women). Musculoskeletal malformations and transposition of the great arteries appeared more frequently after exposure to fluconazole, even with a single 150 mg dose. Fluconazole is an azole antifungal, used in particular at low oral doses for some patients with vaginal candidiasis (1). In pregnant women, there is an established teratogenic risk associated with high-dose oral fluconazole (prolonged treatment with at least 400 mg per day). For low doses of fluconazole (single or possibly repeated doses of 150 mg) used in vaginal candidiasis, only a few small-scale epidemiological studies were available until 2020, which did not allow a risk of malformation to be ruled out (2-7). At the end of April 2020, a cohort study assessed the risk of malformations after exposure to oral fluconazole, at cumulative doses of 150 mg to 600 mg, during the first trimester of pregnancy. The authors studied, in particular, malformations observed during previous studies: musculoskeletal malformations, conotruncal malformations and oral clefts (8). Here are the main results.
机译:一项基于美国报销数据的大规模队列研究比较了婴儿在怀孕前三个月接触氟康唑(至少一剂150毫克;约4万名女性)或局部抗真菌药物(约8万名女性)后的畸形情况。即使单次服用150毫克氟康唑,暴露于氟康唑后,肌肉骨骼畸形和大动脉转位的发生率也更高。氟康唑是一种唑类抗真菌药,特别是在低剂量口服时用于一些阴道念珠菌病患者(1)。在孕妇中,大剂量口服氟康唑(每天至少400毫克的长期治疗)存在已确定的致畸风险。对于用于阴道念珠菌病的低剂量氟康唑(单剂量或可能重复剂量150 mg),直到2020年,只有少数小规模流行病学研究可用,这不允许排除畸形风险(2-7)。2020年4月底,一项队列研究评估了孕早期口服氟康唑(累积剂量150毫克至600毫克)后的畸形风险。作者特别研究了先前研究中观察到的畸形:肌肉骨骼畸形、圆锥管畸形和口裂(8)。以下是主要结果。

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    《Prescrire international》 |2021年第223期|共2页
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  • 正文语种 eng
  • 中图分类 药学;
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