Department of Pharmacology, AIIMS, New Delhi, India.
Department of Pharmacology, AIIMS, New Delhi, India.
Epilepsy Behav. 2019 Nov;100(Pt A):106439. doi: 10.1016/j.yebeh.2019.07.040. Epub 2019 Sep 28.
The study investigated overall adverse event (AE) burden and specifically psychiatric and behavioral side effects (PBAEs) in persons with epilepsy (PWE) on antiepileptic drugs (AEDs) monotherapy. It also assessed their correlation with neuroendocrine and oxidative stress biomarkers.
This cross-sectional observational study was conducted at a tertiary care hospital between 2016 and 2018. Persons with epilepsy above 18 years on monotherapy of levetiracetam (LEV) and conventional AEDs {carbamazepine (CBZ), phenytoin (PHT), or valproate (VPA)} for at least 6 months were enrolled. Validated questionnaires, 'Mini-International Neuropsychiatric Interview (MINI 7.02)', 'Depression, Anxiety, and Stress Scale 21 (DASS-21)', 'Buss-Perry Aggression Questionnaire (BPAQ)', 'patient-weighted Quality of life Index in Epilepsy (QOLIE-10)', 'Pittsburgh Sleep Quality Index (PSQI)', and 'Liverpool Adverse Events Profile (LAEP)' were used to assess the PBAEs, quality of life, sleep quality, and AE profile. A subgroup of PWE recruited consecutively were considered for estimation of the following neuroendocrine biomarker levels: brain-derived neurotrophic factor (BDNF), homovanillic acid (HVA), 5-hydroxyindoleacetic acid (5-HIAA), and total antioxidant capacity (TAC) which were then correlated with scores of above questionnaires.
After screening 220 PWE, 163 PWE (58 on LEV and 105 on conventional AEDs) with a mean age of 29 ± 10 years were enrolled. Mini-International Neuropsychiatric Interview revealed that LEV group had higher association with PBAEs and lower quality of sleep compared to conventional AEDs (p = 0.032 and 0.046, respectively). Other scales did not show significant difference between LEV and conventional AEDs. In the subset of PWE (n = 74, 36 on LEV and 38 on conventional AEDs), LEV group had more association with the PBAEs (p = 0.010), higher physical aggression and anger components of BPAQ (p = 0.03 and 0.02, respectively), and more AE (p = 0.049) than conventional AED group. However, there was no significant difference in neuroendocrine biomarker levels.
Levetiracetam had a higher association with PBAEs and more AE when compared to conventional AEDs. There was no differential correlation of AEDs with the following neuroendocrine markers: BDNF, HVA, 5-HIAA, and TAC. These facts necessitate exploration of other mechanisms for LEV-induced PBAEs.
本研究旨在调查接受抗癫痫药物（AED）单药治疗的癫痫患者（PWE）的总体不良事件（AE）负担，特别是精神和行为副作用（PBAE），并评估其与神经内分泌和氧化应激生物标志物的相关性。
这是一项在 2016 年至 2018 年期间在一家三级保健医院进行的横断面观察性研究。纳入了至少接受左乙拉西坦（LEV）和传统 AED（卡马西平[CBZ]、苯妥英[PHT]或丙戊酸钠[VPA]）单药治疗至少 6 个月、年龄在 18 岁以上的 PWE。使用经过验证的问卷，即“迷你国际神经精神病学访谈（MINI 7.02）”、“抑郁、焦虑和压力量表 21（DASS-21）”、“Buss-Perry 攻击性问卷（BPAQ）”、“患者加权癫痫生活质量指数（QOLIE-10）”、“匹兹堡睡眠质量指数（PSQI）”和“利物浦不良事件概况（LAEP）”来评估 PBAE、生活质量、睡眠质量和 AE 概况。连续招募了一组 PWE 来估算以下神经内分泌生物标志物水平：脑源性神经营养因子（BDNF）、高香草酸（HVA）、5-羟吲哚乙酸（5-HIAA）和总抗氧化能力（TAC），然后将这些标志物与上述问卷的评分相关联。
在筛选了 220 名 PWE 后，共纳入了 163 名 PWE（58 名服用 LEV，105 名服用传统 AED），平均年龄为 29±10 岁。MINI 神经精神病学访谈显示，LEV 组与 PBAE 的相关性更高，睡眠质量更差，与传统 AEDs 相比（p=0.032 和 0.046）。其他量表在 LEV 和传统 AED 之间没有显示出显著差异。在 PWE 亚组（n=74，36 名服用 LEV，38 名服用传统 AED）中，LEV 组与 PBAE 的相关性更高（p=0.010），BPAQ 的身体攻击性和愤怒成分更高（p=0.03 和 0.02），AE 更多（p=0.049），与传统 AED 组相比。然而，神经内分泌生物标志物水平没有差异。
与传统 AED 相比，LEV 与 PBAE 相关性更高，AE 更多。AED 与以下神经内分泌标志物：BDNF、HVA、5-HIAA 和 TAC 无差异相关。这些事实需要探索 LEV 诱导的 PBAE 的其他机制。
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