评估孕期使用普瑞巴林的致畸影响:一项多中心病例对照研究。

Northern clinics of Istanbul Pub Date : 2024-10-03 eCollection Date: 2024-01-01 DOI:10.14744/nci.2024.57702
Mert Kaskal, Busra Kuru, Ilknur Erkoseoglu, Huseyin Yilmaz, Baris Karadas, M Zafer Goren
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引用次数: 0

摘要

目的:有关普瑞巴林使用情况的信息十分有限。我们的目的是评估在怀孕期间某段时间服用普瑞巴林的患者的妊娠结局。方法:研究纳入了 31 名在怀孕期间使用普瑞巴林治疗的患者,以及 93 名在 2013-2022 年期间到医院就诊的对照组患者。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和新生儿健康状况进行了评估:结果发现:与对照组相比,普瑞巴林组的早产率(5/27 (18.5%) vs. 5/87 (5.7%);OR 0.26,95% CI 0.07-1.01,p=0.04)和出生体重(6/27 (22.2%) vs. 5/81 (6.6%);OR 4.34,95% CI 1.20-15.65,p=0.016)更高。然而,通过对数秩检验(P=0.30),普瑞巴林组和对照组婴儿的出生日期没有发现明显差异。自然流产率没有明显差异(2/31(6.4%)对 4/93(4.3%);OR 1.52,95% CI 0.26-8.72,P=0.63)。虽然普瑞巴林的重大畸形率高于对照组(3/27(11%)vs 4/88(4.5%);OR 0.38,95% CI 0.07-1.82,p=0.21),但结果在统计学上并不显著:结论:普瑞巴林组的早产率和出生体重较低。结论:普瑞巴林组孕妇的早产率和出生体重降低率较高,同时也不应忽视普瑞巴林组孕妇的慢性疾病可能会对结果产生不良影响。
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Evaluation of the teratogenic effects of pregabalin usage during pregnancy: A multicenter case-control study.

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.

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