PDF(Pubmed)
Abstract：
OBJECTIVE: 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).
METHODS: 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.
METHODS: 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).
METHODS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
METHODS: 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).
METHODS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：使用加泰罗尼亚的电子健康记录（EHRs）（初级保健研究发展系统，SIDIAP).
方法：药物利用队列研究，涵盖2011年1月至2020年6月。该研究包括通过算法确定的加泰罗尼亚妇女的怀孕事件。
方法：数据来自SIDIAP，一个全面的EHR存储库，包括来自各种数据源的信息：记录的处方（医院和初级保健），由初级保健医生确定的诊断和社会人口统计学特征，和ASSIR的性健康和生殖健康数据（由妇科医生和助产士使用）。
方法：在2011年1月至2020年6月期间发生了至少一次妊娠发作的12-50岁女性，并且在怀孕期间至少服用了丙戊酸钠。
方法：主要结果包括丙戊酸盐暴露，通过妊娠和妊娠期间的患病率和累积发生率来衡量。监管措施的影响(风险缓解措施、RMM)进行了评估，和处方随时间的变化使用中断时间序列分析进行分析。次要结果包括健康问题，妊娠结局,吸烟习惯和社会经济特征。
结果：总共确认了99605例妊娠，至少有3.03‰（95％CI2.69‰至3.39‰）在某个时间点暴露于丙戊酸盐（302次怀孕，276名妇女）。中位妊娠时间为38.30周（IQR12.6-40.1），妊娠年龄中位数为32.37岁（IQR27.20-36.56）。癫痫是最常见的健康问题。妊娠期间丙戊酸盐处方的患病率和累积发生率下降，妊娠后增加。2014年实施的RMM导致该队列怀孕期间每月丙戊酸盐处方减少。
结论：该研究强调了由于RMM导致的妊娠期间丙戊酸盐处方的减少，并强调了在未来研究中需要标准化方法，以确保妊娠患者的安全性并优化科学证据。
方法：药物利用队列研究，涵盖2011年1月至2020年6月。该研究包括通过算法确定的加泰罗尼亚妇女的怀孕事件。
方法：数据来自SIDIAP，一个全面的EHR存储库，包括来自各种数据源的信息：记录的处方（医院和初级保健），由初级保健医生确定的诊断和社会人口统计学特征，和ASSIR的性健康和生殖健康数据（由妇科医生和助产士使用）。
方法：在2011年1月至2020年6月期间发生了至少一次妊娠发作的12-50岁女性，并且在怀孕期间至少服用了丙戊酸钠。
方法：主要结果包括丙戊酸盐暴露，通过妊娠和妊娠期间的患病率和累积发生率来衡量。监管措施的影响(风险缓解措施、RMM)进行了评估，和处方随时间的变化使用中断时间序列分析进行分析。次要结果包括健康问题，妊娠结局,吸烟习惯和社会经济特征。
结果：总共确认了99605例妊娠，至少有3.03‰（95％CI2.69‰至3.39‰）在某个时间点暴露于丙戊酸盐（302次怀孕，276名妇女）。中位妊娠时间为38.30周（IQR12.6-40.1），妊娠年龄中位数为32.37岁（IQR27.20-36.56）。癫痫是最常见的健康问题。妊娠期间丙戊酸盐处方的患病率和累积发生率下降，妊娠后增加。2014年实施的RMM导致该队列怀孕期间每月丙戊酸盐处方减少。
结论：该研究强调了由于RMM导致的妊娠期间丙戊酸盐处方的减少，并强调了在未来研究中需要标准化方法，以确保妊娠患者的安全性并优化科学证据。
