基于美国FDA不良事件报告系统数据库的儿童患者应用孟鲁司特风险信号挖掘  

Study on the risk signal mining related to montelukast in pediatric patients based on the US FDA Adverse Event Reporting System Database

作　　者：刘彦会 阮文懿 陈慧颖 梅康康 蔡和平 Liu Yanhui;Ruan Wenyi;Chen Huiying;Mei Kangkang;Cai Heping(Department of Clinical Pharmacy,Anhui Provincial Children′s Hospital,Hefei 230000,China)

机构地区：[1]安徽省儿童医院临床药学部,合肥230000

出　　处：《药物不良反应杂志》2023年第8期469-474,共6页Adverse Drug Reactions Journal

摘　　要：目的挖掘儿童患者应用孟鲁司特的不良事件(AE)风险信号,为临床安全使用该药提供参考。方法收集美国食品药品管理局(FDA)不良事件报告系统数据库2004年第1季度至2022年第3季度以孟鲁司特为首要怀疑药物的儿童患者AE报告,采用国际医学用语词典23.0版首选术语(PT)和系统器官分类(SOC)对AE进行标准化和分类。提取患儿一般情况和AE结局等资料进行描述性统计分析。采用比例报告比值比(PRR)法挖掘患儿应用孟鲁司特钠的AE风险信号,将报告数≥3、PRR≥2且χ^(2)>4的AE定义为阳性信号,进行描述性分析。结果纳入分析的AE报告共5179例,涉及1295个PT,采用PRR法获得233个阳性PT。AE报告数居前10位的PT为攻击性行为、焦虑、自杀意念、异常行为、抑郁、愤怒、噩梦、失眠、大声哭泣和夜惊,除大声哭泣外,均为说明书已记载的不良反应。信号强度居前10位的PT为感觉超负荷、心率异常、离别焦虑障碍、孤独恐怖症、灰尘过敏、Miller‑Fisher综合征、嗜酸性肉芽肿合并多血管炎、儿童人格障碍、夜惊和血小板黏附性下降,其中心率异常、Miller‑Fisher综合征和血小板黏附性下降为药品说明书中未记载的不良反应。233个阳性PT中共59个在药品说明书中未记载,涉及10个SOC,居前5位者依次为社会环境,精神疾病,损伤、中毒和手术并发症,一般病症和给药部位情况,呼吸、胸腔和纵隔疾病。结论美国FDA不良事件报告系统数据库中儿童患者应用孟鲁司特后的主要AE为攻击性行为、焦虑、抑郁、失眠、夜惊等,均为药品说明书已记载的不良反应;药品说明书中未记载的不良反应包括心率异常、Miller‑Fisher综合征和血小板黏附性下降等。Objective To explore the risk signals of montelukast‑related adverse events(AEs)in pediatric patients and provide reference for the safe use.Methods AE reports of children with montelukast as the primary suspect drug from the first quarter of 2004 to the third quarter of 2022 were collected by searching the US FDA Adverse Event Reporting System database(FAERS).AEs were standardized and classified according to the preferred terms(PT)and system organ class(SOC)of Medical Dictionary for Regulatory Activities 23.0.Proportional reporting odds ratio(PRR)method was used to mine the AE risk signals of montelukast.An AE with reports≥3,PRR≥2,andχ^(2)>4 was defined as a positive signal,which were analyzed using descriptive method.Results A total of 5179 AE reports were included in the analysis,involving 1295 PTs,and 233 positive PTs were obtained by PRR method.The top 10 PTs in AE reports were aggressive behavior,anxiety,suicidal ideation,abnormal behavior,depression,anger,nightmares,insomnia,crying loudly and night terrors.Except crying loudly,all of them were adverse reactions recorded in the label.The top 10 PTs in signal intensity were sensory overload,arrhythmia,separation anxiety disorder,loneliness phobia,dust allergy,Mille‑Fisher syndrome,eosinophilic granuloma complicated with polyangitis,personality disorder in children,night terrors and decreased platelet adhesion.Among them,abnormal heart rate,Mille‑Fisher syndrome and decreased platelet adhesion were not recorded in the label.A total of 59 of the 233 positive PTs were not recorded in the label,involving 10 SOCs.The top 5 SOCs were social environment,mental illness,injury,poisoning and surgical complications,general conditions and administration site,and respiratory,thoracic and mediastinal diseases.Conclusion The main AEs of pediatric patients receiving montelukast treatment in the US FAERS are aggressive behavior,anxiety,depression,insomnia,night terrors,etc.,all of which are adverse reactions recorded in the label;adverse reactions not recorded in

关 键 词：抗哮喘药 白三烯受体拮抗剂 儿童 数据挖掘 不良事件报告系统数据库 孟鲁司特 

分 类 号：R97[医药卫生—药品]