Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study
Paroxetine and fluoxetine in pregnancy: a prospective, multicentre, controlled, observational study
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DOI：
10.1111/j.1365-2125.2008.03261.x
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发表时间：
2008-11-01
影响因子：
3.4
通讯作者：
Ornoy, Asher
中科院分区：
文献类型：
--
作者：
Diav-Citrin, Orna;Shechtman, Svetlana;Ornoy, Asher
目的：最近的研究表明，孕妇在妊娠早期使用选择性血清素再摄取抑制剂（SSRIs）与心血管异常之间可能存在关联。本研究的目的是评估帕罗西汀和氟西汀的致畸风险。方法本研究是一项多中心、前瞻性、对照研究，评估妊娠早期暴露于帕罗西汀、氟西汀或非致畸物后主要先天性异常的发生率。结果随访帕罗西汀组410例，氟西汀组314例，对照1467例。排除遗传和细胞遗传学异常后，SSRI组的主要异常发生率高于对照组[帕罗西汀18/348(5.2%)，氟西汀12/253（4.7%）和对照组34/1359(2.5%)]。主要风险为心血管异常[帕罗西汀7/348(2.0%)，粗优势比（OR） 3.47, 95%可信区间（CI） 1.13, 10.58；氟西汀7/253(2.8%)，粗OR， 4.81 95% CI 1.56, 14.71；对照8/1359(0.6%)]。在logistic回归分析中，只有吸烟>= 10支天（-1）和氟西汀暴露是心血管异常的显著变量。帕罗西汀和氟西汀调整后的or分别为2.66 （95% CI 0.80, 8.90）和4.47 （95% CI 1.31, 15.27）。结论本研究提示妊娠早期氟西汀暴露可能与心血管异常有关。
AIMSRecent studies have suggested a possible association between maternal use of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy and cardiovascular anomalies. The aim of the present study was to evaluate the teratogenic risk of paroxetine and fluoxetine.METHODSThis multicentre, prospective, controlled study evaluated the rate of major congenital anomalies after first-trimester gestational exposure to paroxetine, fluoxetine or nonteratogens.RESULTSWe followed up 410 paroxetine, 314 fluoxetine first-trimester exposed pregnancies and 1467 controls. After exclusion of genetic and cytogenetic anomalies, there was a higher rate of major anomalies in the SSRI groups compared with the controls [paroxetine 18/348 (5.2%), fluoxetine 12/253 (4.7%) and controls 34/1359 (2.5%)]. The main risk applied to cardiovascular anomalies [paroxetine 7/348 (2.0%), crude odds ratio (OR) 3.47, 95% confidence interval (CI) 1.13, 10.58; fluoxetine 7/253 (2.8%), crude OR, 4.81 95% CI 1.56, 14.71; and controls 8/1359 (0.6%)]. On logistic regression analysis only cigarette smoking of >= 10 cigarettes day(-1) and fluoxetine exposure were significant variables for cardiovascular anomalies. The adjusted ORs for paroxetine and fluoxetine were 2.66 (95% CI 0.80, 8.90) and 4.47 (95% CI 1.31, 15.27), respectively.CONCLUSIONThis study suggests a possible association between cardiovascular anomalies and first-trimester exposure to fluoxetine.