Epilepsy Initiative Group, Clinical Neurosciences, Royal Free London NHS Foundation Trust, London, UK.
UCL Queen Square Institute of Neurology, London, UK.
Acta Neurol Scand. 2020 Jun;141(6):483-490. doi: 10.1111/ane.13231. Epub 2020 Mar 10.
Annual completion of a Valproate Risk Acknowledgement Form (RAF) is mandated in the United Kingdom due to neurodevelopmental risks of in utero valproate exposure. The number of women of childbearing potential taking valproate, the uptake of the RAF within this population and their clinical outcomes is not known or monitored. This study surveyed responses of clinicians administering the RAF to women of childbearing potential taking valproate medications.
Study design-national online survey distributed to clinical specialists throughout the United Kingdom via their national organizations. Participants-clinicians qualified to counsel and administer the valproate RAF (as defined by the Medicines and Healthcare products Regulatory Agency). Main outcome measures-quantitative and qualitative responses regarding identification, uptake, effects and reactions to the RAF. Trial registration-registered at the Clinical Governance and Audit Committee at Royal Free London NHS Foundation Trust Hospital.
215 respondents covering more than 4775 patient encounters were captured. Most patients continued on valproate, 90% with epilepsy as the indication. Respondents reported that seizure control deteriorated when switched to levetiracetam (33%) and lamotrigine (43%), compared to 7% when continuing valproate (P < .001).
33%-43% of clinicians reported seizure control deterioration in women changed to alternatives to valproate. Informed consent requires women considering a change are given this information. Systematic capture of data automated through online RAFs and linked to patient outcomes is needed. There remains little data on valproate given for indications other than epilepsy.
由于胎儿暴露于丙戊酸的神经发育风险，在英国，每年完成丙戊酸盐风险知情同意书（RAF）是强制性的。目前尚不清楚或监测有生育能力的妇女服用丙戊酸盐的人数、该人群中 RAF 的接受情况及其临床结局。本研究调查了为服用丙戊酸盐药物的有生育能力的妇女管理 RAF 的临床医生的反应。
研究设计-通过其国家组织向英国各地的临床专家分发全国性在线调查。参与者-有资格咨询和管理丙戊酸盐 RAF 的临床医生（由药品和保健品管理局定义）。主要观察指标-关于 RAF 的识别、接受情况、效果和反应的定量和定性反应。试验注册-在伦敦皇家自由国家卫生服务基金会信托医院的临床治理和审计委员会注册。
共捕获了 215 名回答者，涉及超过 4775 次患者就诊。大多数患者继续服用丙戊酸盐，90%的患者癫痫是适应证。与继续服用丙戊酸盐（7%）相比，转换为左乙拉西坦（33%）和拉莫三嗪（43%）时，受访者报告癫痫发作控制恶化（P<.001）。
33%-43%的临床医生报告说，改用丙戊酸盐替代药物的女性癫痫发作控制恶化。在考虑更改的女性中，需要给予知情同意。需要通过在线 RAF 自动捕获数据并与患者结局相关联，以实现系统数据采集。关于丙戊酸盐用于除癫痫以外的适应证的数据仍然很少。
