与新型抗癫痫药物相关的眼部疾病：FDA 不良事件报告系统的真实世界药物不良反应比例分析。
Eye disorders associated with newer antiepileptic drugs: A real-world disproportionality analysis of FDA adverse event reporting system.
机构信息
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu 610041, Sichuan, China.
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu 610041, Sichuan, China.
出版信息
Seizure. 2022 Mar;96:66-73. doi: 10.1016/j.seizure.2022.01.011. Epub 2022 Jan 22.
BACKGROUND
Newer antiepileptic drugs such as levetiracetam, lacosamide, topiramate, gabapentin, oxcarbazepine, lamotrigine, and zonisamide are prescribed by physicians for the treatment of epilepsy. These drugs are also associated with a series of eye disorders. However, very few studies have systemically compared eye disorders associated with newer AEDs in a large sample of patients diagnosed with epilepsy.
OBJECTIVE
This study aimed to evaluate the association between eye disorders and several newer AEDs, and also to examine the differences in the frequency of adverse events across individual AEDs through data mining of the self-reporting US Food and Drug Administration Adverse Event Report System (FAERS) database.
METHODS
The definition relied upon system organ class and preferred terms according to the Medical Dictionary for Regulatory Activities. Disproportionality analysis was used to detect the risk signals from the FAERS database. The proportional reporting ratio, and χ2 (chi-square) values were calculated to assess the association between AEs and AED use.
RESULTS
FAERS reports for 158,095 cases from January 1 of 2015 to September 30 of 2020 were included. AEDs were associated with a series of eye-related AEs that were defined by 106 preferred terms and could be classified into 10 aspects.
CONCLUSION
There is variation in the types and severity of eye-related AEs across individual AEDs. Typically, topiramate and lamotrigine are more likely to cause serious eye-related AEs. In contrast, lacosamide rarely results in any severe eye-related AEs, and only diplopia and metamorphopsia are significant. levetiracetam tends to produce ocular neuromuscular disorder-related AEs. Macula-related AEs are associated with gabapentin. zonisamide appears to be closely associated with choroidal effusion and angle-closure glaucoma. oxcarbazepine is primarily associated with several cornea-related AEs.
背景
新型抗癫痫药物，如左乙拉西坦、拉科酰胺、托吡酯、加巴喷丁、奥卡西平、拉莫三嗪和唑尼沙胺，被医生用于治疗癫痫。这些药物也与一系列眼部疾病有关。然而，很少有研究在大型癫痫患者样本中系统比较与新型抗癫痫药物相关的眼部疾病。
目的
本研究旨在评估几种新型抗癫痫药物与眼部疾病的关联，并通过挖掘美国食品和药物管理局不良事件报告系统（FAERS）数据库中的自我报告数据，检查个别抗癫痫药物之间不良事件频率的差异。
方法
该定义依赖于根据监管活动医学词典的系统器官类别和首选术语。使用不相称性分析从 FAERS 数据库中检测风险信号。计算比例报告比和 χ2（卡方）值，以评估 AE 与 AED 使用之间的关联。
结果
纳入了 2015 年 1 月 1 日至 2020 年 9 月 30 日期间 FAERS 报告的 158095 例病例。AED 与一系列眼部相关 AE 相关，这些 AE 由 106 个首选术语定义，可以分为 10 个方面。
结论
个别 AED 之间眼部相关 AE 的类型和严重程度存在差异。通常，托吡酯和拉莫三嗪更有可能引起严重的眼部相关 AE，而拉科酰胺很少导致任何严重的眼部相关 AE，只有复视和视物变形是显著的。左乙拉西坦倾向于引起眼部神经肌肉障碍相关 AE。与黄斑相关的 AE 与加巴喷丁有关。佐尼沙胺似乎与脉络膜渗出和闭角型青光眼密切相关。奥卡西平主要与几种角膜相关 AE 相关。
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