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与抗癫痫药物相关的运动障碍:对美国食品药品监督管理局不良事件报告系统的真实世界不成比例性分析

Movement disorders associated with antiseizure medications: A real-world disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System.

作者信息

Zhou Jianxing, Wei Zipeng, Chen Shengyang, Xie Helin, Huang Wei, Liu Maobai, Wu Xuemei

机构信息

School of Pharmacy, Fujian Medical University, Fuzhou, Fujian, China.

Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.

出版信息

Br J Clin Pharmacol. 2023 Nov;89(11):3389-3400. doi: 10.1111/bcp.15836. Epub 2023 Jul 18.

DOI:10.1111/bcp.15836
PMID:37353394
Abstract

AIMS

Patients with epilepsy often require long-term use of antiseizure medications (ASMs) to control their seizures. However, movement disorders (MDs) related to ASMs can significantly impact their quality of life. This study aims to analyse MDs related to ASMs in the Food and Drug Administration Adverse Event Reporting System database to provide recommendations for safe medication.

METHODS

All adverse drug reactions associated with 26 marketed ASMs in Food and Drug Administration Adverse Event Reporting System were extracted for analysis. Disproportionality analyses were used to assess the association between ASMs and MDs, and signal colour scale maps were created to identify potential ASM-MD safety signals.

RESULTS

A total of 1921 cases experienced MDs while taking ASMs were included. A higher prevalence of MDs was observed in females compared to males. The association between specific MDs with ASMs was revealed, including known and unknown MDs such as tremors, Parkinson and paralysis. Lamotrigine and carbamazepine exhibited multiple significant MDs, while levetiracetam and pregabalin were linked to the earlier onset of MDs. Generally, higher doses were linked to a higher incidence of MDs.

CONCLUSION

MDs were the most obvious adverse drug reactions in the nervous system triggered by using ASMs. Fourteen drugs exhibited positive signals for MDs, including some not previously reported. Conversely, 12 ASMs were deemed to have a lower possibility of inducing MDs. The incidence of MDs can be mitigated by selecting appropriate ASMs for epileptic patients. These findings enhance our understanding of the relationship between ASMs and MDs.

摘要

目的

癫痫患者通常需要长期使用抗癫痫药物(ASMs)来控制癫痫发作。然而,与ASMs相关的运动障碍(MDs)会显著影响他们的生活质量。本研究旨在分析美国食品药品监督管理局不良事件报告系统数据库中与ASMs相关的MDs,为安全用药提供建议。

方法

提取美国食品药品监督管理局不良事件报告系统中与26种已上市ASMs相关的所有药物不良反应进行分析。采用不成比例分析评估ASMs与MDs之间的关联,并创建信号色标图以识别潜在的ASM-MD安全信号。

结果

共纳入1921例服用ASMs时出现MDs的病例。女性MDs的患病率高于男性。揭示了特定MDs与ASMs之间的关联,包括已知和未知的MDs,如震颤、帕金森病和麻痹。拉莫三嗪和卡马西平表现出多种显著的MDs,而左乙拉西坦和普瑞巴林与MDs的较早发作有关。一般来说,较高剂量与MDs的较高发生率相关。

结论

MDs是使用ASMs引发的神经系统中最明显的药物不良反应。14种药物表现出MDs的阳性信号,包括一些以前未报道的。相反,12种ASMs被认为诱发MDs的可能性较低。通过为癫痫患者选择合适的ASMs可以减轻MDs的发生率。这些发现增强了我们对ASMs与MDs之间关系的理解。

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