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Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design

机译:妊娠早期选择性5-羟色胺再摄取抑制剂和文拉法辛与出生缺陷风险:基于人群的队列研究和兄弟姐妹设计

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摘要

>Objective To assess whether use of specific selective serotonin reuptake inhibitors (SSRIs) or venlafaxine in early pregnancy is associated with an increased risk of birth defects, with emphasis on cardiovascular birth defects even when accounting for lifestyle or other familial confounding.>Design Multicountry population based cohort study, including sibling controlled design.>Setting Nordic population (Denmark, Finland, Iceland, Norway, and Sweden) identified from nationwide health registers at different periods in 1996-2010.>Population The full study cohort included women giving birth to 2.3 million live singletons. The sibling cohort included 2288 singleton live births. The sibling controlled analyses included sibling pairs who were discordant for exposure to SSRIs or venlafaxine and birth defects.>Main outcome measure Prevalence of birth defects, including subtypes of cardiac defects. Odds ratio of birth defects from logistic and conditional logistic regression.>Results Among 36 772 infants exposed to any SSRI in early pregnancy, 3.7% (n=1357) had a birth defect compared with 3.1% of 2 266 875 unexposed infants, yielding a covariate adjusted odds ratio of 1.13 (95% confidence interval 1.06 to 1.20). In the sibling controlled analysis the adjusted odds ratio decreased to 1.06 (0.91 to 1.24). The odds ratios for any cardiac birth defect with use of any SSRI or venlafaxine were 1.15 (95% confidence interval 1.05 to 1.26) in the covariate adjusted analysis and 0.92 (0.72 to 1.17) in the sibling controlled analysis. For atrial and ventricular septal defects the covariate adjusted odds ratio was 1.17 (1.05 to 1.31). Exposure to any SSRI or venlafaxine increased the prevalence of right ventricular outflow tract obstruction defects, with a covariate adjusted odds ratio of 1.48 (1.15 to 1.89). In the sibling controlled analysis the adjusted odds ratio decreased to 0.56 (0.21 to 1.49) for any exposure to SSRIs or venlafaxine and right ventricular outflow tract obstruction defects.>Conclusions In this large Nordic study no substantial increase was found in prevalence of overall cardiac birth defects among infants exposed to SSRIs or venlafaxine in utero. Although the prevalence of septal defects and right ventricular outflow tract defects was higher in exposed infants, the lack of an association in the sibling controlled analyses points against a teratogenic effect of these drugs.
机译:>目的:评估妊娠早期使用特定的选择性血清素再摄取抑制剂(SSRI)或文拉法辛是否会增加出生缺陷的风险,重点是心血管出生缺陷,即使考虑到生活方式或其他家族性疾病也是如此>设计基于多国人群的队列研究,包括同级对照设计。>设置北欧人(丹麦,芬兰,冰岛,挪威和瑞典)从全国各地的健康登记册中识别出来>人口的整个研究对象包括生育230万单身女性的妇女。同胞队列包括2288个单胎活产。兄弟姐妹对照分析包括对SSRIs或文拉法辛暴露和出生缺陷不满意的兄弟对。>主要结局指标出生缺陷的患病率,包括心脏缺陷的亚型。通过逻辑和条件逻辑回归分析得出的出生缺陷的几率。>结果在妊娠早期接受任何SSRI的36 772婴儿中,有3.7%(n = 1357)有出生缺陷,而2 266的这一比例为3.1% 875名未暴露婴儿,其协变量调整后的优势比为1.13(95%置信区间1.06至1.20)。在同级对照分析中,调整后的优势比降低至1.06(0.91至1.24)。在协变量调整分析中,使用任何SSRI或文拉法辛的任何心脏出生缺陷的比值比为1.15(95%置信区间1.05至1.26),在兄弟姐妹对照分析中为0.92(0.72至1.17)。对于房间隔和室间隔缺损,协变量调整后的优势比为1.17(1.05至1.31)。暴露于任何SSRI或文拉法辛都会增加右心室流出道梗阻缺损的发生率,协变量调整后的优势比为1.48(1.15至1.89)。在同级对照分析中,任何暴露于SSRI或文拉法辛和右室流出道阻塞性缺陷的患病率,调整后的优势比均降低至0.56(0.21至1.49)。>结论子宫内暴露于SSRIs或文拉法辛的婴儿中总体心脏出生缺陷的患病率。尽管在暴露的婴儿中,间隔缺损和右心室流出道缺损的患病率较高,但在兄弟姐妹对照分析中缺乏关联表明这些药物具有致畸作用。

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