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孕期使用普瑞巴林的致畸作用评估:一项多中心病例对照研究。

Evaluation of the teratogenic effects of pregabalin usage during pregnancy: A multicenter case-control study.

作者信息

Kaskal Mert, Kuru Busra, Erkoseoglu Ilknur, Yilmaz Huseyin, Karadas Baris, Goren M Zafer

机构信息

Department of Medical Pharmacology, Marmara University Faculty of Medicine, Istanbul, Turkiye.

Department of Medical Pharmacology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkiye.

出版信息

North Clin Istanb. 2024 Oct 3;11(5):460-465. doi: 10.14744/nci.2024.57702. eCollection 2024.

DOI:10.14744/nci.2024.57702
PMID:39431036
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11487309/
Abstract

OBJECTIVE

Information regarding pregabalin use is limited. We aimed to assess the outcome of the patients who have taken pregabalin at a certain time during their pregnancies.

METHODS

31 patients used pregabalin treatment during pregnancy and 93 control patients were included in the study who applied to hospital between the years 2013-2022. In this multicenter case-controlled study, the outcome of the pregnancies and the health condition of the newborn in the pregabalin and control groups were evaluated.

RESULTS

Preterm delivery rates (5/27 (18.5%) vs. 5/87 (5.7%); OR 0.26, 95% CI 0.07-1.01, p=0.04) and lower birth weight (6/27 (22.2%) vs. 5/81 (6.6%); OR 4.34, 95% CI 1.20-15.65, p=0.016) were found higher in the pregabalin group compared to the control group. However, significant difference was not found between the birth dates of babies in pregabalin and control groups with the log-rank test (p=0.30). Spontaneous abortion rates were not significantly different (2/31 (6.4%) vs. 4/93 (4.3%); OR 1.52, 95% CI 0.26-8.72, p=0.63). Although major malformation rates in pregabalin were higher than those in controls (3/27 (11%) vs. 4/88 (4.5%); OR 0.38, 95% CI 0.07-1.82, p=0.21) the outcomes were statistically insignificant.

CONCLUSION

Preterm delivery rates and lower birth weight were higher in pregabalin group. Also, it should not be ignored that chronic diseases of the pregnant women in pregabalin group may affect the outcomes poorly.

摘要

目的

有关普瑞巴林使用的信息有限。我们旨在评估在孕期某一阶段服用过普瑞巴林的患者的结局。

方法

31例患者在孕期使用普瑞巴林进行治疗,93例对照患者纳入本研究,这些对照患者于2013年至2022年间到医院就诊。在这项多中心病例对照研究中,对普瑞巴林组和对照组的妊娠结局及新生儿健康状况进行了评估。

结果

与对照组相比,普瑞巴林组的早产率(5/27(18.5%)对5/87(5.7%);比值比0.26,95%置信区间0.07 - 1.01,p = 0.04)和低出生体重发生率(6/27(22.2%)对5/81(6.6%);比值比4.34,95%置信区间1.20 - 15.65,p = 0.016)更高。然而,通过对数秩检验发现普瑞巴林组和对照组婴儿的出生日期之间无显著差异(p = 0.30)。自然流产率无显著差异(2/31(6.4%)对4/93(4.3%);比值比1.52,95%置信区间0.26 - 8.72,p = 0.63)。尽管普瑞巴林组的严重畸形率高于对照组(3/27(11%)对4/88(4.5%);比值比0.38,95%置信区间0.07 - 1.82,p = 0.21),但结果在统计学上无显著意义。

结论

普瑞巴林组的早产率和低出生体重发生率更高。此外,不应忽视普瑞巴林组孕妇的慢性疾病可能对结局产生不良影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7df/11487309/c931874308e9/NCI-11-460-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7df/11487309/c931874308e9/NCI-11-460-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7df/11487309/c931874308e9/NCI-11-460-g001.jpg

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本文引用的文献

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Prenatal exposure to pregabalin, birth outcomes and neurodevelopment - a population-based cohort study in four Nordic countries.产前暴露于普瑞巴林、出生结局和神经发育 - 四个北欧国家的基于人群的队列研究。
Drug Saf. 2023 Jul;46(7):661-675. doi: 10.1007/s40264-023-01307-2. Epub 2023 Apr 26.
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The Effects of Prenatal Exposure to Pregabalin on the Development of Ventral Midbrain Dopaminergic Neurons.产前暴露于普瑞巴林对腹侧中脑多巴胺能神经元发育的影响。
Cells. 2022 Mar 1;11(5):852. doi: 10.3390/cells11050852.
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Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study.
与妊娠期间最常使用的抗癫痫药物相关的产前暴露的早期神经发育结局风险:一项法国全国基于人群的队列研究。
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Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth.宫内暴露于抗癫痫药物与妊娠持续时间及出生时大小的关系。
PLoS One. 2019 Aug 5;14(8):e0214180. doi: 10.1371/journal.pone.0214180. eCollection 2019.
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Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials.普瑞巴林治疗神经性疼痛的疗效和安全性:一项随机临床试验的快速评价和荟萃分析。
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Adverse pregnancy outcomes in women exposed to gabapentin and pregabalin: data from a population-based study.暴露于加巴喷丁和普瑞巴林的女性的不良妊娠结局:一项基于人群研究的数据。
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