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Oral fluconazole use in the first trimester and risk of congenital malformations: population based cohort study.

孕早期口服氟康唑使用与先天性畸形风险: 基于人群的队列研究。

  • 影响因子:0
  • DOI:10.1136/bmj.m1494
  • 作者列表:"Zhu Y","Bateman BT","Gray KJ","Hernandez-Diaz S","Mogun H","Straub L","Huybrechts KF
  • 发表时间:2020-05-20
Abstract

OBJECTIVE:To examine the risk of congenital malformations associated with exposure to oral fluconazole at commonly used doses in the first trimester of pregnancy for the treatment of vulvovaginal candidiasis. DESIGN:Population based cohort study. SETTING:A cohort of pregnancies publicly insured in the United States, with data from the nationwide Medicaid Analytic eXtract 2000-14. PARTICIPANTS:Pregnancies of women enrolled in Medicaid from three or more months before the last menstrual period to one month after delivery, and infants enrolled for three or more months after birth. INTERVENTIONS:Use of fluconazole and topical azoles was established by requiring one or more prescriptions during the first trimester of pregnancy. MAIN OUTCOME MEASURES:Risk of musculoskeletal malformations, conotruncal malformations, and oral clefts (primary outcomes), associated with exposure to oral fluconazole, diagnosed during the first 90 days after delivery, were examined. RESULTS:The study cohort of 1 969 954 pregnancies included 37 650 (1.9%) pregnancies exposed to oral fluconazole and 82 090 (4.2%) pregnancies exposed to topical azoles during the first trimester. The risk of musculoskeletal malformations was 52.1 (95% confidence interval 44.8 to 59.3) per 10 000 pregnancies exposed to fluconazole versus 37.3 (33.1 to 41.4) per 10 000 pregnancies exposed to topical azoles. The risks of conotruncal malformations were 9.6 (6.4 to 12.7) versus 8.3 (6.3 to 10.3) per 10 000 pregnancies exposed to fluconazole and topical azoles, respectively; risks of oral clefts were 9.3 (6.2 to 12.4) versus 10.6 (8.4 to 12.8) per 10 000 pregnancies, respectively. The adjusted relative risk after fine stratification of the propensity score was 1.30 (1.09 to 1.56) for musculoskeletal malformations, 1.04 (0.70 to 1.55) for conotruncal malformations, and 0.91 (0.61 to 1.35) for oral clefts overall. Based on cumulative doses of fluconazole, the adjusted relative risks for musculoskeletal malformations, conotruncal malformations, and oral clefts overall were 1.29 (1.05 to 1.58), 1.12 (0.71 to 1.77), and 0.88 (0.55 to 1.40) for 150 mg of fluconazole; 1.24 (0.93 to 1.66), 0.61 (0.26 to 1.39), and 1.08 (0.58 to 2.04) for more than 150 mg up to 450 mg of fluconazole; and 1.98 (1.23 to 3.17), 2.30 (0.93 to 5.65), and 0.94 (0.23 to 3.82) for more than 450 mg of fluconazole, respectively. CONCLUSIONS:Oral fluconazole use in the first trimester was not associated with oral clefts or conotruncal malformations, but an association with musculoskeletal malformations was found, corresponding to a small adjusted risk difference of about 12 incidents per 10 000 exposed pregnancies overall.

摘要

目的: 研究妊娠早期口服氟康唑治疗外阴阴道念珠菌病相关先天畸形的风险。 设计: 基于人群的队列研究。 设置: 美国公开保险的妊娠队列,数据来自全国医疗补助分析提取物 2000-14。 参与者: 从最后一次月经前三个月或更长时间到分娩后一个月,以及出生后三个月或更长时间的婴儿参加医疗补助的妇女的怀孕。 干预措施: 通过在妊娠早期需要一个或多个处方来确定氟康唑和局部唑类药物的使用。 主要结局指标: 检查了分娩后前 90 天诊断的与口服氟康唑暴露相关的肌肉骨骼畸形、圆锥干畸形和口腔裂隙的风险 (主要结局)。 结果: 研究队列 1 969 954 例妊娠包括 37 650 例 (1。9%) 暴露于口服氟康唑的妊娠和 82 090 (4.2%) 妊娠暴露于孕早期局部唑类。暴露于氟康唑的每 10 000 例妊娠中肌肉骨骼畸形的风险为 52.1 (95% 置信区间 44.8 至 59.3),而暴露于局部唑类的每 10 000 例妊娠中,肌肉骨骼畸形的风险为 37.3 (33.1 至 41.4)。每 10 000 名孕妇暴露于氟康唑和局部唑类药物后,圆锥干畸形的风险分别为 9.6 (6.4-12.7) 和 8.3 (6.3-10.3); 每 10 000 例妊娠中口腔裂隙的风险分别为 9.3 (6.2-12.4) 和 10.6 (8.4-12.8)。倾向评分精细分层后的校正相对风险为: 肌肉骨骼畸形 1.30 (1.09 ~ 1.56),圆锥干畸形 1.04 (0.70 ~ 1.55),0.91 (0.61 ~ 1.35) 对于整体口腔裂缝。基于氟康唑的累积剂量,肌肉骨骼畸形、圆锥干畸形和口腔裂缝的调整相对风险总体为 1.29 (1.05 至 1.58) 、 1.12 (0.71 至 1.77),和 0.88 (0.55 至 1.40) 用于 150 mg氟康唑; 1.24 (0.93 至 1.66),0.61 (0.26 至 1.39),1.08 (0.58 至 2.04) 超过 150 mg至 450 mg氟康唑; 1.98 (1.23 至 3.17),2.30 (0.93 至 5.65),0.94 mg以上的氟康唑分别为 0.23 (3.82 ~ 450)。 结论: 孕早期口服氟康唑与口腔裂隙或圆锥干畸形无关,但与肌肉骨骼畸形有关。对应于总体每 10 000 次暴露妊娠约 12 次事件的小调整风险差异。

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翻译标题与摘要 下载文献
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肌肉骨骼畸形方向

肌肉骨骼系统的先天性结构异常和畸形。

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