Thelengana A, Shukla Garima, Srivastava Achal, Singh Mamta Bhushan, Gupta Anupama, Rajan Roopa, Vibha Deepti, Pandit Awadh Kishor, Prasad Kameshwar
Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Epilepsy Res. 2019 Feb;150:58-65. doi: 10.1016/j.eplepsyres.2019.01.004. Epub 2019 Jan 8.
There is limited literature on cognitive, behaviour and sleep-related adverse effects of levetiracetam and oxcarbazepine among adult epilepsy patients, except for what is available from the initial efficacy trials. This study was initiated with the aim to evaluate the incidence and prevalence of various cognitive, behaviour and sleep-related adverse effects of levetiracetam versus oxcarbazepine among people with epilepsy.
The study was conducted in two parts: part A was a cross-sectional study, and part B was a longitudinal study. Trail making test A & B, digit symbol substitution test, Stroop colour and word test, controlled oral word association test and PGI memory scale, Neuropsychiatric Inventory, sleep log and ESS-I were used for assessment of cognitive, behaviour and sleep-related adverse effects.
In the cross-sectional as well as prospective study, no significant difference was observed in the cognitive performance of patients in levetiracetam and oxcarbazepine group in any of the cognitive assessment. Among 120 patients enrolled in the cross-sectional study, significantly higher number of patients in the levetiracetam group compared to the oxcarbazepine group,had agitation/aggression (20% vs10%, p = 0.047) and irritability (26.7% vs 3.3%, p = 0.007).Among 132 patients enrolled in the prospective study, significantly higher increase in the domain score of agitation/aggression (14.5% vs 1.6%, p = 0.028) and irritability (17.7% vs 1.6%, p = 0.018) was observed in the levetiracetam group compared to oxcarbazepine group. A significantly higher proportion of patients in the oxcarbazepine group had hypersomnolence (11.3% vs 1.6%, p = 0.026), as compared to the levetiracetam group.
On cross-sectional as well as on longitudinal assessment, nearly one-fifth of patients on levetiracetam have behaviour related adverse effects, with dose modification required for half among these. Nearly 11% of patients on oxcarbazepine reported sleep-related adverse effects (higher total sleep duration per 24 h).
除了最初的疗效试验中所提供的信息外，关于左乙拉西坦和奥卡西平在成年癫痫患者中引起的认知、行为及睡眠相关不良反应的文献有限。本研究旨在评估癫痫患者中左乙拉西坦与奥卡西平在各种认知、行为及睡眠相关不良反应方面的发生率和患病率。
本研究分两部分进行：A部分为横断面研究，B部分为纵向研究。采用连线测验A和B、数字符号替换测验、斯特鲁普颜色和文字测验、受控口语联想测验、PGI记忆量表、神经精神科问卷、睡眠日志和ESS-I来评估认知、行为及睡眠相关不良反应。
在横断面研究以及前瞻性研究中，在任何认知评估中，左乙拉西坦组和奥卡西平组患者的认知表现均未观察到显著差异。在横断面研究纳入的120例患者中，左乙拉西坦组出现激动/攻击行为（20%对10%，p = 0.047）和易怒（26.7%对3.3%，p = 0.007）的患者数量显著高于奥卡西平组。在前瞻性研究纳入的132例患者中，与奥卡西平组相比，左乙拉西坦组在激动/攻击行为（14.5%对1.6%，p = 0.028）和易怒（17.7%对1.6%，p = 0.018）方面的领域得分显著升高。与左乙拉西坦组相比，奥卡西平组出现嗜睡的患者比例显著更高（11.3%对1.6%，p = 0.026）。
在横断面和纵向评估中，近五分之一服用左乙拉西坦的患者有行为相关不良反应，其中一半需要调整剂量。近11%服用奥卡西平的患者报告有睡眠相关不良反应（每24小时总睡眠时间更长）。
