基于FAERS的小剂量甲氨蝶呤药品不良事件信号挖掘研究

目的分析真实世界中小剂量甲氨蝶呤(MTX)的药品不良事件(ADE)信号,为其合理用药提供参考。方法收集2018年第1季度至2019年第4季度美国食品和药物管理局(FDA)不良事件报告系统(FAERS)数据,采用比例报告比值(PRR)法和报告比值比(ROR)法对ADE进行分析和信号挖掘。结果获得以小剂量MTX为首要怀疑药物的ADR报告45 496例,其中女性占73.03%,年龄18~65岁者占53.94%,常用给药途径为口服、皮下注射及肌肉注射;报告主要来源于加拿大、美国和德国;以全身性疾病及给药部位各种反应、各种肌肉骨骼及结缔组织疾病、胃肠系统疾病、各类损伤、中毒及手术并发症等不良事件报告较多。结论临床小剂量使用MTX时,应重点监测全身性疾病及给药部位各种反应、各种肌肉骨骼及结缔组织疾病,防止并发症的发生。

Data-Mining of Adverse Drug Event Signals Induced by Low-Dose Methotrexate Based on FAERS

Objective To analyze the adverse drug event(ADE)signals induced by low-dose methotrexate in the real world,and to provide a reference for rational drug use.Methods Eight quarterly data from the first quarter of 2018 to the fourth quarter of 2019 were downloaded from FDA Adverse Event Reporting System(FAERS).Data-mining of ADE signals was performed by using proportional reporting ratio(PRR)algorithm and reporting odd ratio(ROR)method.Results A total of 45496 ADE cases induced by low-dose methotrexate as the primary suspected drug were reported.Among them,73.03%of patients were female,and 53.94%of patients were aged 18-65 years old.Oral administration,subcutaneous injection and intramuscular injection were the most common administration routes.The reports were mainly from Canada,the United States and Germany.Adverse drug events in general disorders and administration site conditions,musculoskeletal and connective tissue disorders,gastrointestinal disorders,injury,poisoning and procedural complications were frequently reported.Conclusion Emphasis should be put on general disorders and administration site conditions,musculoskeletal and connective tissue disorders in clinical practice of low-dose methotrexate to prevent the occurrence of complications.