新生儿使用猪肺磷脂风险信号挖掘与分析：基于FAERS真实世界研究

Signal mining and analysis of risk signals for neonatal use of poractant alfa: a real-world study based on FAERSShanshan Li Longhui Shen(Women and Children

关键词:  新生儿  猪肺磷脂  药品不良事件  风险信号

Key words:  Neonatal  poractant alfa  adverse drug events  risk signals

摘要:

目的 基于美国FDA不良事件报告系统(FAERS)数据库挖掘与分析新生儿使用猪肺磷脂的不良事件(AE)信号,为新生儿安全使用该药提供参考。 方法 使用OpenVigil 2.1-MedDRA数据平台,收集FAERS数据库中2004年第1季度至2024年第1季度以猪肺磷脂为首要怀疑药物的相关AE报告,采用比例失衡法中的比例报告比值(PRR)法和报告比值比(ROR)法进行数据挖掘,应用《国际医学用语词典》26.1版中药物不良反应术语集的首选术语(PT)和首选系统器官分类(SOC)对挖掘到的风险信号进行分类和描述。结果 共收集到新生儿使用猪肺磷脂的药物不良事件(ADE)报告622例,涉及223个PT。上报数较多的国家是美国、波兰、中国；通过PRR法和ROR法计算及筛选后共获得43个ADE阳性信号,其中ADE信号频数位于前3位的PT分别为新生儿乏氧、新生儿肺出血、新生儿心动过缓,ADE信号强度(PRR法)位于前3位的PT分别为新生儿乏氧、呼气末二氧化碳减少和新生儿心脏呼吸骤停。与猪肺磷脂说明书对比,有36个ADE信号尚未被说明书收录,如未明确定义的疾病、新生儿死亡、婴儿呼吸暂停等；涉及10个新的SOC,分别为感染及侵染类疾病,全身性疾病及给药部位各种反应,各种手术及医疗操作,皮肤及皮下组织类疾病,各类损伤、中毒及操作并发症,各类神经系统疾病,妊娠期、产褥期及围产期状况,代谢及营养类疾病,胃肠系统疾病,血液及淋巴系统疾病。 结论 基于FAERS数据库AE信号的挖掘显示,新生儿临床使用猪肺磷脂时,除了关注说明书中记载的不良反应外,还应关注未明确定义的疾病、新生儿死亡、婴儿呼吸暂停、呼气末二氧化碳减少和新生儿心脏呼吸骤停等不良事件,保障新生儿用药安全。

Abstract:

ABSTRACT: OBJECTIVE Mining and Analysing Adverse Event (AE) Signals for Neonatal Use of Poractant Alfa Based on the US FDA Adverse Event Reporting System (FAERS) Database. METHODS AE reports related to Poractant Alfa were collected from the FAERS database from Q1 2004 to Q1 2024 using the OpenVigil 2.1 data platform. The Proportional Reporting Ratio (PRR) method and Reporting Ratio Ratio (ROR) method of the Proportional Imbalance Method were used for data mining. The mined risk signals were classified and described using the preferred terminology (PT) and preferred system organ classification (SOC) of the Adverse Drug Reaction Terminology Set in the International Dictionary of Medical Terminology (version 26.1). RESULTS A total of 622 adverse drug event (ADE) reports involving 223 ADE signals were collected in which Poractant Alfa were the main suspected drugs. The countries with a higher number of reported cases are the United States, Poland, and China. A total of 43 ADE positive signals were obtained after calculation and screening for exclusion by PRR and ROR methods. Among them, the ADE signals with signal frequency in the top 3 were neonatal hypoxia, pulmonary haemorrhage neonatal, and bradycardia neonatal. The top 3 PTs in terms of ADE signal intensity (PRR method) were neonatal hypoxia, end-tidal co2 decreased and cardio-respiratory arrest neonatal. In comparison with the Poractant Alfa specification, 36 ADE signals were not yet included in the specification, such as ill-defined disorder, death neonatal, and infantile apnoea. There are 10 new SOCs, including infections and infestations, general disorders and administration site conditions, surgical and medical procedures, skin and subcutaneous tissue disorders, injury, poisoning and procedural complications, nervous system disorders, pregnancy, puerperium and perinatal conditions, gastrointestinal disorders, vascular disorders. CONCLUSION When clinical application of Poractant Alfa in neonates is concerned about ill-defined disorder, death neonatal, and infantile apnoea, in addition to the adverse reactions documented in the specification, to ensure the safety of neonatal medication.