Department of Mental Health and Addiction, Health Care Trust-IRCCS San Gerardo Monza, Monza, Italy.
School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
JAMA Netw Open. 2024 Nov 4;7(11):e2443648. doi: 10.1001/jamanetworkopen.2024.43648.
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders, and it afflicts about 7% of young people. As a consequence, many young women might be pregnant while taking medication for ADHD, but data about safety have not yet been strictly examined.
To examine adverse effects in offspring of mothers receiving treatment with atomoxetine and methylphenidate during pregnancy.
Electronic databases (PubMed, Embase, and PsycINFO) were searched for articles published through December 31, 2023, with the following search terms: (atomoxetine OR methylphenidate) AND (pregnancy).
Observational studies (eg, cohort studies, case-control studies, case-crossover studies, cross-sectional studies, and registry-based studies) that reported offspring outcomes in pregnancy with atomoxetine and/or methylphenidate and in mothers with ADHD but unexposed to ADHD treatment during pregnancy or from the general population were included. Ten studies of 656 records satisfied criteria.
Two independent reviewers performed data extraction according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Meta-analyses were conducted based on reported odds ratios (ORs) and corresponding 95% CIs using a linear random effects model. Each study was inversely weighted by the reported variance of the estimators. Risk of publication bias and analysis of heterogeneity through univariate and multivariate metaregressions were also rated. Data were analyzed from January to March 2024.
Study outcomes included miscarriages and congenital anomalies.
Ten studies involving 16 621 481 pregnant women, 30 830 of them affected by ADHD, were included. Congenital anomalies or miscarriages were not more frequent in offspring of mothers receiving treatment with methylphenidate or atomoxetine during pregnancy compared with unexposed offspring (OR, 1.14; 95% CI, 0.83-1.55; P = .41; I2 = 8% for congenital anomalies; OR, 1.01; 95% CI, 0.70-1.47; P = .96; I2 = 0% for miscarriages) or compared with the general population (OR, 1.19; 95% CI, 0.93-1.53; P = .16; I2 = 74% for congenital anomalies; OR, 1.05, 95% CI, 0.81-1.37; P = .70; I2 = 0% for miscarriage).
Evidence from this meta-analysis, which involves a substantial sample of pregnant women with and without ADHD, suggests the maintenance of methylphenidate or atomoxetine during pregnancy is safe, given that congenital anomalies and miscarriages did not appear to significantly increase. Further studies are recommended to support and confirm these findings.
注意力缺陷/多动障碍（ADHD）是最常见的神经行为障碍之一，影响着约 7%的年轻人。因此，许多年轻女性在接受 ADHD 药物治疗时可能已经怀孕，但有关安全性的数据尚未经过严格审查。
检查接受阿托西汀和哌甲酯治疗的母亲在怀孕期间对后代的不良影响。
电子数据库（PubMed、Embase 和 PsycINFO）搜索了截至 2023 年 12 月 31 日发表的文章，使用的搜索词包括：（阿托西汀或哌甲酯）和（怀孕）。
纳入了报告阿托西汀和/或哌甲酯治疗母亲在怀孕期间和 ADHD 未暴露于 ADHD 治疗的母亲或一般人群中所生孩子结局的观察性研究（如队列研究、病例对照研究、病例交叉研究、横断面研究和基于登记的研究）。符合标准的有 656 条记录的 10 项研究。
两名独立审查员根据系统评价和荟萃分析的首选报告项目指南进行数据提取。根据报告的比值比（OR）和相应的 95%置信区间（CI），使用线性随机效应模型进行荟萃分析。每个研究的权重都根据估计值的报告方差进行了反向加权。还对发表偏倚风险和通过单变量和多变量荟萃回归进行的异质性分析进行了评估。数据于 2024 年 1 月至 3 月进行分析。
研究结果包括流产和先天性异常。
纳入了 16621481 名孕妇的 10 项研究，其中 30830 名孕妇患有 ADHD。与未暴露于药物的后代相比，接受甲基苯丙胺或阿托西汀治疗的母亲在怀孕期间所生孩子的先天性异常或流产并不更常见（OR，1.14；95%CI，0.83-1.55；P=0.41；I2=8%用于先天性异常；OR，1.01；95%CI，0.70-1.47；P=0.96；I2=0%用于流产）或与一般人群相比（OR，1.19；95%CI，0.93-1.53；P=0.16；I2=74%用于先天性异常；OR，1.05，95%CI，0.81-1.37；P=0.70；I2=0%用于流产）。
这项荟萃分析涉及大量患有和不患有 ADHD 的孕妇，证据表明，在怀孕期间维持使用哌甲酯或阿托西汀是安全的，因为先天性异常和流产似乎没有明显增加。建议进行进一步的研究来支持和证实这些发现。
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