PDF(Pubmed)
Abstract：
Epilepsy is a chronic neurological disease characterized by the presence of spontaneous seizures, with a higher incidence in the pediatric population. Anti-seizure medication (ASM) may produce adverse drug reactions (ADRs) with an elevated frequency and a high severity. Thus, the objective of the present study was to analyze, through intensive pharmacovigilance over 112 months, the ADRs produced by valproic acid (VPA), oxcarbazepine (OXC), phenytoin (PHT), and levetiracetam (LEV), among others, administered to monotherapy or polytherapy for Mexican hospitalized pediatric epilepsy patients. A total of 1034 patients were interviewed; 315 met the inclusion criteria, 211 patients presented ADRs, and 104 did not. A total of 548 ASM-ADRs were identified, and VPA, LEV, and PHT were the main culprit drugs. The most frequent ADRs were drowsiness, irritability, and thrombocytopenia, and the main systems affected were hematologic, nervous, and dermatologic. LEV and OXC caused more nonsevere ADRs, and PHT caused more severe ADRs. The risk analysis showed an association between belonging to the younger groups and polytherapy with ADR presence and between polytherapy and malnutrition with severe ADRs. In addition, most of the severe ADRs were preventable, and most of the nonsevere ADRs were nonpreventable.
摘要：
癫痫是一种以自发性癫痫发作为特征的慢性神经系统疾病，在儿科人群中发病率较高。抗癫痫药物（ASM）可能会产生频率升高且严重程度高的药物不良反应（ADR）。因此，本研究的目的是分析，经过112个月的强化药物警戒,丙戊酸（VPA）产生的ADR，奥卡西平（OXC），苯妥英(PHT),和左乙拉西坦（LEV），其中,对墨西哥住院小儿癫痫患者进行单药治疗或综合治疗。共采访了1034例患者；315例符合纳入标准，211例患者出现不良反应，104没有。总共确定了548个ASM-ADR，VPA,LEV,PHT是主要的罪魁祸首药物。最常见的不良反应是嗜睡，烦躁，和血小板减少症,受影响的主要系统是血液系统，紧张,和皮肤病学。LEV和OXC引起更多非严重ADR，和PHT引起更严重的ADR。风险分析显示，属于年轻群体与ADR存在的综合疗法之间以及综合疗法与严重ADR的营养不良之间存在关联。此外,大多数严重的不良反应是可以预防的，大多数非重度ADRs是无法预防的.
