Fondation Fondamental, Créteil, France; Department of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, EA 7280, Clermont-Ferrand, France.
Fondation Fondamental, Créteil, France; INSERM U955, Équipe de Psychiatrie Translationnelle, Université Paris-Est Créteil, DHU Pe-PSY, Pôle de Psychiatrie des Hôpitaux Universitaires H Mondor, Créteil, France.
J Affect Disord. 2020 Nov 1;276:963-969. doi: 10.1016/j.jad.2020.07.078. Epub 2020 Jul 21.
Valproate is associated with teratogenic and neurodevelopmental effects. Several agencies have restricted the conditions of its prescription in bipolar disorders (BD). We aimed to assess the evolution of valproate prescription and the clinical profile of BD women of childbearing age receiving valproate.
Based on a large national cohort, we included all BD women 16-50 years old. Sociodemographic, clinical and pharmacological data were recorded. Logistic regression analyses were used to describe variables associated with valproate prescription.
Of the 1018 included women 16-50 years old, 26.9% were treated with valproate with a mean daily dosage of 968 mg. The prevalence of BD women using valproate was 32.6% before May 2015 and 17.3% after May 2015 (p<0.001), the date of French regulatory publication of restriction of valproate prescription. The multivariate analysis revealed that the inclusion period after May 2015 (OR=0.54, CI 95% 0.37-0.78, p=0.001), the age lower than 40 years (OR=0.65, CI 95% 0.43-0.98, p=0.040) and the number of lifetime mood episodes (OR=0.98, CI 95% 0.95-0.99, p=0.040) were the variables negatively associated with the use of valproate.
Study could be underpowered to determine a clinical profile associated with valproate prescription.
The regulatory change in BD women of childbearing age had a significant impact on valproate prescription, even if the prescription rate remains high. Important efforts are needed to help clinicians and patients to improve quality of care in BD women of childbearing age.
丙戊酸盐与致畸和神经发育影响有关。一些机构已经限制了双相障碍（BD）中丙戊酸盐的使用条件。我们旨在评估丙戊酸盐处方的演变以及接受丙戊酸盐治疗的育龄期 BD 女性的临床特征。
基于一个大型全国队列，我们纳入了所有 16-50 岁的 BD 女性。记录了人口统计学、临床和药理学数据。使用逻辑回归分析描述了与丙戊酸盐处方相关的变量。
在纳入的 1018 名 16-50 岁的女性中，26.9%的人接受丙戊酸盐治疗，平均日剂量为 968mg。在 2015 年 5 月之前，使用丙戊酸盐的 BD 女性患病率为 32.6%，在 2015 年 5 月之后，这一比例为 17.3%（p<0.001），这也是法国发布限制丙戊酸盐处方的监管文件的日期。多变量分析显示，2015 年 5 月以后的纳入期（OR=0.54，95%CI 0.37-0.78，p=0.001）、年龄低于 40 岁（OR=0.65，95%CI 0.43-0.98，p=0.040）和一生中情绪发作次数（OR=0.98，95%CI 0.95-0.99，p=0.040）是与使用丙戊酸盐负相关的变量。
本研究可能不足以确定与丙戊酸盐处方相关的临床特征。
在育龄期 BD 女性中，监管变化对丙戊酸盐的处方产生了重大影响，尽管处方率仍然很高。需要做出重要努力，以帮助临床医生和患者提高育龄期 BD 女性的护理质量。
