Ankarfeldt Mikkel Zöllner, Petersen Janne, Andersen Jon Trærup, Fernandes Maria Fernanda Scantamburlo, Li Hu, Motsko Stephen Paul, Fast Thomas, Jimenez-Solem Espen
Copenhagen Phase IV Unit (Phase4CPH), Department of Clinical Pharmacology and Center for Clinical Research and Prevention, Copenhagen University Hospital Bispebjerg and Frederiksberg, Hovedvejen opgang 5, Nordre Fasanvej 57, 2000, Frederiksberg, Copenhagen, Denmark.
Section for Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Drugs Real World Outcomes. 2023 Mar;10(1):69-81. doi: 10.1007/s40801-022-00334-2. Epub 2022 Nov 10.
Depression or depressive symptoms are common among pregnant women. The use of antidepressants during pregnancy has grown steadily. The risk of offspring being born small for gestational age or prematurely when exposed to duloxetine during pregnancy is not established.
We aimed to investigate the association between duloxetine exposure during pregnancy and offspring being born small for gestational age or prematurely.
We conducted an observational study including live births in Sweden and Denmark (2004-2016). Duloxetine exposure during early (0-140 days) or late (141 to delivery) pregnancy compared with duloxetine-non-exposed, selective serotonin reuptake inhibitor-exposed, venlafaxine-exposed, and duloxetine discontinuers.
In total, 2,083,467 pregnancies were identified, where 1589 and 450 were duloxetine exposed in early and late pregnancy, respectively. For small for gestational age, no increased risk was seen for duloxetine across comparators. In the early and late exposure windows, propensity score-matched odds ratios for small for gestational age ranged between 0.64 (95% confidence interval 0.44-0.95) and 1.48 (95% confidence interval 0.85-2.57). For preterm birth, the findings differed across comparators and exposure-time windows, but trended towards an increased risk for duloxetine-exposed when compared with duloxetine-non-exposed, selective serotonin reuptake inhibitor-exposed, and duloxetine discontinuers in both early exposure and late exposure. The odds ratios ranged between 1.17 and 2.04, of which some did not reach statistical significance. No clear association was observed when compared with venlafaxine exposed, 0.91 (95% confidence interval 0.73-1.14) for early exposure and 1.26 (95% confidence interval 0.86-1.86) for late exposure. Most preterm births (79.2%) occurred in weeks 33-36 of gestation.
Duloxetine exposure during pregnancy is unlikely to increase the risk of small for gestational age. Although not consequently statistically significant across comparisons, a trend towards an increased risk of preterm birth was observed for duloxetine exposed. Therefore, an increased risk of preterm birth cannot be excluded, especially for women exposed to duloxetine throughout pregnancy.
抑郁症或抑郁症状在孕妇中很常见。孕期使用抗抑郁药的情况一直在稳步增加。孕期暴露于度洛西汀的后代出现小于胎龄儿或早产的风险尚未明确。
我们旨在研究孕期暴露于度洛西汀与后代小于胎龄儿或早产之间的关联。
我们进行了一项观察性研究，纳入了瑞典和丹麦（2004 - 2016年）的活产病例。将孕早期（0 - 140天）或孕晚期（141天至分娩）暴露于度洛西汀的情况与未暴露于度洛西汀、暴露于选择性5-羟色胺再摄取抑制剂、暴露于文拉法辛以及停用度洛西汀的情况进行比较。
总共识别出2,083,467例妊娠，其中孕早期和孕晚期分别有1589例和450例暴露于度洛西汀。对于小于胎龄儿，与各比较组相比，度洛西汀未显示出风险增加。在孕早期和孕晚期暴露窗口，小于胎龄儿的倾向评分匹配优势比在0.64（95%置信区间0.44 - 0.95）至1.48（95%置信区间0.85 - 2.57）之间。对于早产，各比较组和暴露时间窗口的结果有所不同，但与未暴露于度洛西汀、暴露于选择性5-羟色胺再摄取抑制剂以及停用度洛西汀的情况相比，孕早期和孕晚期暴露于度洛西汀的情况均有早产风险增加的趋势。优势比在1.17至2.04之间，其中一些未达到统计学显著性。与暴露于文拉法辛的情况相比，未观察到明确关联，孕早期为0.91（95%置信区间0.73 - 1.14），孕晚期为1.26（95%置信区间0.86 - 1.86）。大多数早产（79.2%）发生在妊娠第33 - 36周。
孕期暴露于度洛西汀不太可能增加小于胎龄儿的风险。尽管在各项比较中未达到统计学显著性，但观察到暴露于度洛西汀有早产风险增加的趋势。因此，不能排除早产风险增加，尤其是对于整个孕期暴露于度洛西汀的女性。
Zotero 插件
