Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Department of Clinical Research and Management, Center of Biostatistics, Design, Measurement and Evaluation (CBDME), West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Epilepsia. 2024 Nov;65(11):3186-3198. doi: 10.1111/epi.18125. Epub 2024 Sep 17.
To explore seizure control and offspring outcomes associated with antiseizure medication (ASM) withdrawal during the first trimester of pregnancy.
Based on a prospective multicenter study in China, pregnancies followed up between 2009 and 2023 at the neurology outpatient clinic of 50 hospitals were included in this study. Information on demographics, epileptic characteristics, treatment during pregnancy, and offspring outcomes was collected. Pregnancies were categorized into an ASM withdrawal group and an ASM continuation group. Balance tests and univariate log-binomial regression analysis were conducted to identify imbalanced factors between groups and potential risk factors for seizure deterioration during pregnancy. Multivariate log-binomial regression was then used to estimate the adjusted effects of ASM withdrawal on seizure deterioration during pregnancy and fetal outcomes. In addition, exploratory subgroup analysis was conducted to identify high-risk patients who should avoid ASM withdrawal.
Of the 695 pregnancies enrolled, 14.2% withdrew ASMs in the first trimester of pregnancy. ASM withdrawal during this period was associated with a risk of seizure deterioration during pregnancy (adjusted risk ratio [aRR] 1.405, 95% confidence interval [CI] 1.009-1.876). Subgroup analysis revealed a significant risk of seizure deterioration in pregnancies with seizures in 9 months (aRR 1.590, 95% CI 1.079-2.344). After adjusting the folic acid dose, no evidence of protective effects on fetus after ASM withdrawal was observed compared to patients with continued treatment, whereas seizure deterioration during pregnancy increased the risk of fetal death (aRR 3.577, 95% CI 1.086-11.651).
ASM withdrawal in the first trimester of pregnancy did not show a protective effect on fetal outcomes but rather resulted in increased seizure frequency during pregnancy. However, this finding requires a larger sample for validation. Furthermore, seizure deterioration during pregnancy was associated with an increased risk of fetal death.
探讨妊娠早期抗癫痫药物(ASM)停药与癫痫控制及后代结局的关系。
本研究基于中国一项前瞻性多中心研究,纳入 2009 年至 2023 年期间在 50 家医院神经内科门诊随访的妊娠。收集人口统计学、癫痫特征、妊娠期间治疗及后代结局信息。将妊娠分为 ASM 停药组和 ASM 持续用药组。采用平衡检验和单变量二项式回归分析来识别两组之间的不平衡因素及妊娠期间癫痫恶化的潜在危险因素。然后采用多变量二项式回归来估计妊娠期间 ASM 停药对癫痫恶化及胎儿结局的调整效应。此外,还进行了探索性亚组分析,以确定应避免 ASM 停药的高危患者。
695 例妊娠中,14.2%在妊娠早期停用 ASM。在此期间停药与妊娠期间癫痫恶化的风险相关(调整风险比[aRR]1.405,95%置信区间[CI]1.009-1.876)。亚组分析显示,在 9 个月时有癫痫发作的妊娠中,癫痫恶化的风险显著增加(aRR 1.590,95% CI 1.079-2.344)。调整叶酸剂量后,与继续治疗的患者相比,ASM 停药后胎儿并无保护作用,而妊娠期间癫痫恶化增加了胎儿死亡的风险(aRR 3.577,95% CI 1.086-11.651)。
妊娠早期 ASM 停药并未显示对胎儿结局有保护作用,反而增加了妊娠期间癫痫发作频率。然而,这一发现需要更大的样本量进行验证。此外,妊娠期间癫痫恶化与胎儿死亡风险增加相关。