1 University Hospital Policlinico-Vittorio Emanuele, Catania, Italy.
2 Catania University, Italy.
Ann Pharmacother. 2018 Jul;52(7):645-649. doi: 10.1177/1060028018759637. Epub 2018 Feb 14.
Few studies on adult and pediatric patients have shown pyridoxine efficacy as additional therapy for those receiving levetiracetam (LEV) to prevent and mitigate behavioral adverse effects (BAEs).
The aim of our study was to analyze the safety and efficacy of pyridoxine supplementation in the prevention of LEV adverse effects, including suicidal ideation.
This randomized, case-control trial included patients receiving LEV as monotherapy treatment. Patients were subdivided into 2 groups, according to whether they were treated with LEV only (group 1) or LEV with supplemental pyridoxine (group 2).
In both cohorts, the most frequent BAEs were irritability/aggression followed by depression and confusion. Those patients (92%) who initiated pyridoxine after 1 month of LEV treatment did not need to change or suspend LEV ( P < 0.001), and BAE improved after 9.06 ± 3.05 days of pyridoxine supplementation. None of the patients complained of symptoms of pyridoxine toxicity, and no new adverse effects of LEV off-label were reported.
In our study, we found pyridoxine to be safe and effective in controlling LEV-induced BAEs in children.
少数关于成人和儿科患者的研究表明，吡哆醇作为左乙拉西坦（LEV）的附加治疗，可预防和减轻行为不良反应（BAEs）。
我们的研究旨在分析吡哆醇补充治疗预防 LEV 不良反应（包括自杀意念）的安全性和有效性。
这是一项随机、病例对照试验，纳入了接受 LEV 单药治疗的患者。患者根据是否接受 LEV 单药治疗（第 1 组）或 LEV 联合补充吡哆醇治疗（第 2 组）分为两组。
在两个队列中，最常见的 BAEs 是易怒/攻击性，其次是抑郁和混乱。那些在 LEV 治疗 1 个月后开始使用吡哆醇的患者（92%）无需改变或停用 LEV（P<0.001），并且在补充吡哆醇 9.06±3.05 天后，BAE 得到改善。没有患者出现吡哆醇毒性症状，也没有报告 LEV 超适应证的新不良反应。
在我们的研究中，我们发现吡哆醇在控制儿童 LEV 诱导的 BAEs 方面是安全有效的。
