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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.

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

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