Department of Clinical Pharmacology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Department of Pharmacology, Therapeutics and Toxicology, Universitat Autonòma de Barcelona, Barcelona, Spain.
BMJ Open. 2024 Aug 12;14(8):e085167. doi: 10.1136/bmjopen-2024-085167.
To characterise the exposure to valproate within a cohort of pregnant women using electronic health records (EHRs) from Catalonia (System for the Development of Research in Primary Care, SIDIAP).
Drug-utilisation cohort study covering the period from January 2011 to June 2020. The study included pregnancy episodes of women from Catalonia identified by the algorithm.
Data were sourced from SIDIAP, a comprehensive EHR repository that includes information from various data sources: recorded prescriptions (both hospital and primary care), diagnoses and sociodemographic characteristics identified by primary care physicians, and sexual and reproductive health data from ASSIR (used by gynaecologists and midwives).
Women aged 12-50 with at least one pregnancy episode occurred during January 2011-June 2020 and at least a prescription of valproate during pregnancy.
Primary outcomes included valproate exposure, measured through prevalence and cumulative incidence in pregnancy episodes and by trimester. The impact of regulatory measures (risk mitigation measures, RMMs) was assessed, and prescriptions over time were analysed using interrupted time series analysis. Secondary outcomes included health issues, pregnancy outcomes, smoking habits and socioeconomic characteristics.
A total of 99 605 pregnancies were identified, with at least 3.03‰ (95% CI 2.69‰ to 3.39‰) exposed to valproate at some point (302 pregnancies, 276 women). The median pregnancy duration was 38.30 weeks (IQR 12.6-40.1), and the median age at pregnancy was 32.37 years (IQR 27.20-36.56). Epilepsy was the most frequent health issue. The prevalence and cumulative incidence of valproate prescriptions decreased during pregnancy and increased postpregnancy. The RMMs implemented in 2014 led to a reduction in monthly valproate prescriptions during pregnancy in this cohort.
The study highlights the decline in valproate prescriptions during pregnancy due to RMMs and underscores the need for standardised methodologies in future studies to ensure the safety of pregnant patients and optimise scientific evidence.
利用加泰罗尼亚电子健康记录系统（SIDIAP），对一个孕妇队列中使用丙戊酸盐的情况进行特征描述。
这是一项药物利用队列研究，涵盖了 2011 年 1 月至 2020 年 6 月期间的妊娠事件。该研究包括通过算法确定的加泰罗尼亚孕妇的妊娠事件。
数据来源于 SIDIAP，这是一个综合电子健康记录库，包含来自多个数据源的信息：记录处方（包括医院和初级保健）、初级保健医生诊断以及社会人口统计学特征，以及 ASSIR（妇科医生和助产士使用）的生殖健康数据。
年龄在 12-50 岁之间，至少有一次妊娠事件发生在 2011 年 1 月至 2020 年 6 月期间，并且至少有一次丙戊酸盐的处方。
主要结局包括丙戊酸盐的暴露情况，通过妊娠事件和妊娠期间的每个孕期进行患病率和累积发病率来衡量。评估了监管措施（降低风险措施，RMM）的影响，并通过中断时间序列分析分析了随时间的处方情况。次要结局包括健康问题、妊娠结局、吸烟习惯和社会经济特征。
共确定了 99605 次妊娠，其中至少有 3.03‰（95%置信区间 2.69‰至 3.39‰）在某个时候暴露于丙戊酸盐（302 例，276 例妇女）。妊娠持续时间中位数为 38.30 周（IQR 12.6-40.1），妊娠年龄中位数为 32.37 岁（IQR 27.20-36.56）。癫痫是最常见的健康问题。丙戊酸盐处方的患病率和累积发病率在妊娠期间下降，产后增加。2014 年实施的 RMMs 导致该队列中妊娠期间每月丙戊酸盐处方数量减少。
该研究强调了 RMMs 导致的妊娠期间丙戊酸盐处方数量的下降，并强调了在未来研究中使用标准化方法的必要性，以确保孕妇的安全并优化科学证据。
