中国临床药学杂志

目的 了解在真实世界中儿童使用丙戊酸钠与左乙拉西坦发生药物不良事件（ADEs）的相关情况，为临床合理用药提供参考依据。方法 收集美国FDA不良事件呈报系统（FAERS）中儿童使用丙戊酸钠与左乙拉西坦相关的ADEs报告，运用描述性分析和报告比值比（ROR）数据挖掘算法检测这2种药物的不良反应风险信号。结果 通过比较2004年第1季度至2020年第4季度共68个季度的数据，丙戊酸钠上报的有关儿童的ADEs个案报告数量少于左乙拉西坦（814例vs2891例），严重的ADEs占比大于左乙拉西坦（60.4%vs 41.7%），差异均存在统计学意义。信号检测结果显示，丙戊酸钠不良反应风险信号多于左乙拉西坦（476个vs351个），2种药物均涉及的不良反应累及系统器官共9种，丙戊酸钠独有的不良反应累计系统器官有2种，即先天性家族性遗传性疾病和眼器官疾病，占比分别为4.88%和0.46%。左乙拉西坦独有的不良反应累计系统器官有4种，包括各种肌肉骨骼及结缔组织疾病、妊娠期产褥期及围产期状况、感染及侵染类疾病、呼吸系统胸及纵隔疾病，占比分别为2.72%、1.54%、0.59%和0.48%。结论 检测出儿童使用丙戊酸钠与左乙拉西坦均存在认知障碍的风险信号，左乙拉西坦说明书未提及，提示儿科医师需加强关注。

AIM To understand the adverse drug events(ADEs) related to the use of sodium valproate and levetiracetam in children in the real world, and to provide reference for clinical rational drug use. METHODS reports of ADEs associated with the use of sodium valproate and levetiracetam in children in the FDA adverse event reporting system(FAERS) were collected and adverse reaction risk signals for these 2 drugs were detected by using descriptive analysis and the reporting odds ratio(ROR) method. RESULTS By comparing the data from the first quarter of 2004 to the fourth quarter of 2020 for a total of 68 quarters, sodium valproate reported fewer individual case reports of ADEs in children than levetiracetam(814 vs 2 891), but the proportion of serious ADEs was statistically greater than levetiracetam(60.4% vs 41.7%). The signal detection results showed that the risk signals of adverse reactions of sodium valproate were more than those of levetiracetam(476 vs 351). There were 9 kinds of system organs involved in the adverse reactions of both drugs. There were 2 specific kinds of system organs involved in the cumulative adverse reactions of sodium valproate, including congenital familial hereditary diseases and eye organ diseases, accounting for 4.88% and 0.46%, respectively. There were 4 unique adverse reactions of levetiracetam, including musculoskeletal and connective tissue diseases, puerperal and perinatal conditions during pregnancy, infections and infestations, and respiratory thoracic and mediastinal diseases, accounting for 2.72%, 1.54%, 0.59% and 0.48%, respectively. CONCLUSION A risk signal of cognitive impairment detected with both sodium valproate and levetiracetam in children is not mentioned in the levetiracetam package insert, which prompts pediatricians to pay more attention.