摘要
目的:通过对美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)进行检索,挖掘伏立康唑上市后的安全警戒信号,为临床合理用药提供参考。方法:提取FAERS数据库2004年1月至2020年9月关于伏立康唑的不良事件报告,采用比例失衡法(ROR法及PRR法)对其进行不良反应信号挖掘及分析。结果:提取FAERS数据库信息得到伏立康唑不良事件(ADE)报告8601份,采用ROR法和PRR法计算共得到伏立康唑不良反应(ADR)信号375个,筛选出的信号强度前20位的首选术语(PT)中未在说明书中出现的信号共计7个,分别为:氟化物增加、黄斑浑浊、氟中毒、出血时间缩短、肥大性骨关节病、舌坏死、高转换型骨病,多为骨代谢相关ADE。骨代谢相关ADE大多为中青年人,氟化物增加或中毒大多发生在长时间使用伏立康唑的患者(≥279天)。结论:伏立康唑不良反应信号累及器官系统达22个,除需关注已知的精神、肝脏等相关不良反应外,还需要密切关注长疗程伏立康唑治疗患者骨骼系统的不良反应;伏立康唑导致的骨病变可能与体内氟含量高存在密切关系。
Objective:To explore the safety warning signals of voriconazole after its marketing in the Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)to provide reference for clinical rational drug use.Methods:Data were obtained from FAERS database from January 2004 to September 2020.The reported odds ratio method(ROR)and proportional report ratio method(PRR)were utilized to detect and analysis the adverser reactions signals of voriconazole.Results:A total of 8601 reports of voriconazole as a major suspected drug after deduplication were extracted.A total of 375signals were detected by ROR and PRR.A total of 7 signals in the top 20 preferred terms(PT)of signal strength were found that did not appear in the specification,such as:fluoride increase,macular opacity,fluorosis,bleeding time shortened,hypertrophic osteoarthropathy,tongue necrosis,high turnover osteopathy,mostly of them were related to bone metabolism.Bone metabolismrelated ADE was mostly young and middle-aged people,and fluoride increase or fluorosis mostly occurred in patients with prolonged voriconazole use(≥279 days).Conclusion:Voriconazole ADR signals involve 22 organ systems.In addition to pay attention to known mental and hepatic ADR,close attention should be paid to its damage of other organ systems,such as skeletal system.Also found that voriconazole induced bone injury may be closely related to high level of fluoride in vivo.
作者
万青
赖鑫
彭洪薇
潘德城
胡锦芳
胡翔
WAN Qing;LAI Xin;PENG Hongwei;PAN Decheng;HU Jingfang;HU Xiang(The First Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330000,China)
出处
《药品评价》
CAS
2022年第21期1293-1297,共5页
Drug Evaluation
基金
江西省卫生计生委科技计划项目(20185191)。
关键词
伏立康唑
药物相关性副作用和不良反应
信号挖掘
比例失衡法
Voriconazole
Drug-related side effects and adverse reactions
Data mining
Non-proportional analysis
