基于FAERS数据库儿童应用孟鲁司特的不良事件信号挖掘与分析  

Adverse Drug Event Signals Mining and Analysis for Montelukast Used in Children Based on the FAERS Database

作　　者：杨泽平 劳楚瑜 陈景秀 陈杰[1] YANG Zeping;LAO Chuyu;CHEN Jingxiu;CHEN Jie(Department of Pharmacy,The First Afiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510080,China)

机构地区：[1]中山大学附属第一医院药学部,广东广州510080

出　　处：《今日药学》2025年第2期108-113,共6页Pharmacy Today

基　　金：广东省基础与应用基础研究基金企业联合基金(2021A1515220165);广东省药理学会触发器研究基金项目(GLYL2021008);吴阶平医学基金会临床科研专项资助基金(320.6750.2022-20-12)。

摘　　要：目的分析探究孟鲁司特在儿童患者中潜在的不良事件,为临床合理安全用药提供参考。方法收集建库起至2024年第1季度美国食品和药物管理局不良事件报告系统(FAERS)数据库中的儿童使用孟鲁司特相关药品不良事件(ADE)报告,采用《国际医学用语词典》(MedDRA)26.1的系统器官分类(SOC)和首选术语(PT)对挖掘出的不良反应事件(ADE)报告进行归纳、分析,利用报告比值比法(ROR)及英国药品和保健品管理局的综合标准法(MHRA)筛选有效信号。结果从FAERS数据库中筛选出以孟鲁司特为首要怀疑药物的儿童使用报告共6076份,6~14岁发生不良反应的比例最高,占比50.46%,且男性患儿发生不良反应的比例(59.68%)高于女性患儿(38.03%),共挖掘出231个PT信号,涉及20种SOC,其中精神病类和各类神经系统疾病合计累计例次报告占比88.78%,发生频次较高的攻击、焦虑、异常行为、抑郁等均为孟鲁司特说明书收录的ADE,也挖掘出部分说明书未收录的ADE,如感觉超负荷,夜间恐惧、分离焦虑障碍等。结论由于不良事件风险增加和需要监测,不建议使用孟鲁司特作为首选治疗的替代药物,超适应证用药更应谨慎,保留其用于对替代疗法应答不足或不耐受的患者,且使用前需考虑获益是否超过发生不良反应的风险。迫切需要进一步开展流行病学研究,以量化管理风险。OBJECTIVE To investigate the potential adverse events of montelukast in pediatric patients,and provide references for rational and safe clinical use of montelukast.METHODS Adverse drug event(ADE)reports related to the use of montelukast in children in the U.S.Food and Drug Administration's Adverse Event Reporting System from the time of database construction to the 1st quarter of 2024 were collected,and summarized using the System Organ Class(SOC)and Preferred Term(PT)of the International Medical Dictionary for Regulatory Activities(26.1),summarized,analyzed,and valid signals were screened using the Reporting Odds Ratio method and the Medicines and Healthcare Products Regulatory Agency method.RESULTS A total of 6076 reports of children's use of montelukast as the primary suspected drug were screened from the FAERS database,with the highest proportion of adverse reactions occurring in the age group of 6-14 years(50.46%),and the proportion of adverse reactions occurring in male children(59.68%)was higher than that of female children(38.03%),and a total of 231 PT signals were mined for 20 types of SOCs,among them Psychiatric disorders and Nervous system disorders together accounted for 88.78%of the cumulative case reports,ADEs with higher frequency such as aggression,anxiety,abnormal behavior,depression,etc.were included in the instruction manual of montelukast,and some ADEs not included in the instruction manual were excavated,such as sensory overload,nocturnal fear,and separation anxiety disorder.CONCLUSION Due to the increased risk of adverse events and the need for monitoring,the use of montelukast as an alternative agent to preferred therapy is not recommended.Off-label drug use of montelukast should be more cautious,and reserve use for patients who are not treated effectively with or cannot tolerate other allergy medicines.It is necessary to consider whether the benefits outweigh the risks of adverse reactions.Further epidemiological studies are urgently needed to quantify the risk for management.

关 键 词：孟鲁司特 儿童 药品不良事件 FAERS数据库 

分 类 号：R95[医药卫生—药学]