Mbizvo Gashirai K, Dixon Pete, Hutton Jane L, Marson Anthony G
1Institute for Ageing and Chronic Disease, University of Liverpool , Liverpool , UK.
Int J Neurosci. 2014 Sep;124(9):627-34. doi: 10.3109/00207454.2013.866951. Epub 2013 Dec 18.
The adverse effects profile of levetiracetam in epilepsy is still being fully described. We recently published a Cochrane Review evaluating the effectiveness of levetiracetam, added on to usual care, in treating drug-resistant focal epilepsy. The five most common adverse effects were reported and analysed with no scope for reporting any less common adverse effects than those. Here, we report and analyse the remaining adverse effects (including the five most common). These were (in decreasing order of frequency) somnolence; headache; asthenia; accidental injury; dizziness; infection; pharyngitis; pain; rhinitis; abdominal pain; flu syndrome; vomiting; diarrhoea; convulsion; nausea; increased cough; anorexia; upper respiratory tract infection; hostility; personality disorder; urinary tract infection; nervousness; depression; aggression; back pain; agitation; emotional liability; psychomotor hyperactivity; pyrexia; rash; ECG abnormalities; decreased appetite; nasal congestion; irritability; abnormal behaviour; epistaxis; insomnia; altered mood; anxiety; bloody urine; diplopia; dissociation; memory impairment; pruritis; increased appetite; acne; and stomach discomfort. Only somnolence and infection were significantly associated with levetiracetam. When adverse effects pertaining to infection were combined, these affected 19.7% and 15.1% of participants on levetiracetam and placebo (relative risk 1.16, CI 0.89-1.50, Chi(2) heterogeneity p = 0.13). Somnolence and infection further retained significance in adults while no single adverse effect was significant in children. This review updates the adverse effects profile data on levetiracetam use by empirically reporting its common and uncommon adverse effects and analysing their relative importance statistically using data from a group of trials that possess low Risk of Bias and high Quality of Evidence GRADE scores.
左乙拉西坦在癫痫治疗中的不良反应情况仍在全面描述之中。我们最近发表了一篇Cochrane系统评价，评估了在常规治疗基础上加用左乙拉西坦治疗耐药性局灶性癫痫的有效性。报告并分析了五种最常见的不良反应，未涉及报告比这些更罕见的不良反应。在此，我们报告并分析其余的不良反应（包括五种最常见的）。这些不良反应（按发生频率从高到低排列）为：嗜睡；头痛；乏力；意外伤害；头晕；感染；咽炎；疼痛；鼻炎；腹痛；流感样综合征；呕吐；腹泻；惊厥；恶心；咳嗽加重；食欲减退；上呼吸道感染；敌意；人格障碍；尿路感染；紧张；抑郁；攻击行为；背痛；激越；情绪不稳定；精神运动性多动；发热；皮疹；心电图异常；食欲下降；鼻塞；易怒；异常行为；鼻出血；失眠；情绪改变；焦虑；血尿；复视；分离；记忆障碍；瘙痒；食欲增加；痤疮；以及胃部不适。只有嗜睡和感染与左乙拉西坦有显著关联。当合并与感染相关的不良反应时，接受左乙拉西坦和安慰剂治疗的参与者中，分别有19.7%和15.1%受到影响（相对风险1.16，可信区间0.89 - 1.50，卡方异质性p = 0.13）。嗜睡和感染在成人中仍具有显著性，而在儿童中没有单一不良反应具有显著性。本综述通过实证报告左乙拉西坦使用的常见和罕见不良反应，并使用一组具有低偏倚风险和高证据质量GRADE评分的试验数据进行统计学分析，更新了左乙拉西坦使用的不良反应情况数据。
