Karlsson Lind Linnéa, Komen Joris, Wettermark Björn, von Euler Mia, Tomson Torbjörn
Health and Medical Care Administration Stockholm County Council Stockholm Sweden.
Department of Clinical Science and Education Södersjukhuset Karolinska Institutet Stockholm Sweden.
Epilepsia Open. 2018 Jun 13;3(3):357-363. doi: 10.1002/epi4.12228. eCollection 2018 Sep.
In November 2014, the European Medicines Agency (EMA) strengthened restrictions on the use of valproic acid in girls and women of childbearing potential. The objective of this study was to determine whether there has been a change in initiations of valproic acid treatment to females after the regulatory restrictions and to assess if such changes differed between indications (epilepsy and psychiatric disorder).
An interrupted time-series analysis was conducted using all initiations of valproic acid in Stockholm, Sweden. from January 2011 to June 2017. Female and male patients aged 0-45 years with a recorded diagnosis of epilepsy and/or a psychiatric disorder were compared.
Before the EMA warning, a decline in trend of valproic acid initiations was seen in patients with epilepsy. After the warning, a significant decrease of valproic acid initiations was seen in women with a psychiatric disorder, but not in women with epilepsy.
The regulatory warning appeared to have significantly influenced valproic acid initiations in women of childbearing age with a psychiatric disorder. No effect was seen in women with epilepsy, probably because the decline had started long before.
2014年11月，欧洲药品管理局（EMA）加强了对育龄期女性使用丙戊酸的限制。本研究的目的是确定监管限制实施后，女性丙戊酸治疗起始情况是否发生变化，并评估不同适应症（癫痫和精神障碍）之间的变化是否存在差异。
采用中断时间序列分析方法，对瑞典斯德哥尔摩2011年1月至2017年6月期间所有丙戊酸治疗起始情况进行分析。比较了年龄在0至45岁之间、有癫痫和/或精神障碍诊断记录的女性和男性患者。
在EMA发出警告之前，癫痫患者中丙戊酸起始治疗的趋势呈下降。警告发出后，患有精神障碍的女性丙戊酸起始治疗显著减少，但癫痫女性患者未出现这种情况。
监管警告似乎对患有精神障碍的育龄期女性丙戊酸起始治疗产生了显著影响。癫痫女性患者未受影响，可能是因为下降早在之前就已开始。
