摘要
目的基于FDA不良反应报告系统(FAERS)数据库研究非索非那定在真实世界中的药品不良反应(adverse drug reaction,ADR)信号,弥补说明书不足,为临床安全用药提供参考。方法提取FAERS数据库2015年第一季度至2019年第四季度共20个季度的不良反应报告数据,分别检索并提取出以非索非那定为首要怀疑药品的报告,采用比例失衡法中的PRR法和ROR法进行数据挖掘,得到满足信号生成条件的不良反应信号,再删去产品问题等药物无关的不良反应报告,最后将筛除到的不良反应信号进行排序和系统归类。结果获得以非索非那定为首要怀疑药品的不良事件报告共16 477例,男女比为0.47;平均年龄为56.93岁,中位年龄为63岁;报告者大部分为消费者,占96.66%;来自美国的报告占95.79%。挖掘后共得到非索非那定的有效信号91个,报告数5746个。其中ADR集中在呼吸系统、胸及纵隔疾病和精神病类。不良反应报告数最多的ADR为失眠、嗜睡、情绪异常,口干、心悸、心率升高、流泪增加和味觉倒错等未在说明书中提及的ADR。结论非索非那定不良反应信号涉及13个系统,应特别注意对呼吸系统和神经系统不良反应的监测。
Objectives To determine the signals of adverse drug reactions(ADRs)induced by fexofenadine in the real world based on the FDA adverse events reporting system,and to make up for the lack of information in instructions and provide reference for safe clinical use.Methods Firstly,all the ADR data from the first quarter of 2015 to the fourth quarter of 2019 were extracted from the database.The reports with fexofenadine was the primary suspected drug were retrieved and the original data extracted.Then,measures of disproportionality including reporting odds ratio and proportional reporting ratio were used in the data mining of positive signals.Next,unrelated adverse events were deleted before the screened ADR signals were categorized by frequency,relevance and system.Results Totally 16477 adverse events of fexofenadine were reported,with a male-to-female ratio of 0.47.The average age was 56.93 years old,and the median age was 63 years old.Most of the reporters were consumers,accounting for 96.66%.Reports from the United States accounted for 95.79%.After the screening,91 positive signals of fexofenadine were obtained from 5746 reports.ADRs were mainly found in respiratory diseases,psychiatric diseases,thoracic and mediastinal diseases.Common ADRs included insomnia,somnolence and emotional abnormality.ADRs such as dry mouth,palpitations,heart rate increase,lacrimation increase and dysgeusia were not mentioned in the instructions.Conclusion The ADR signal of fexofenadine involve 13 systems.Special attention should be paid to the monitoring of ADRs in the respiratory and nervous systems.
作者
孔金霞
白雪霏
谢昊
何慧琳
陈力
刘芯如
KONG Jin-xia;BAI Xue-fei;XIE Hao;HE Hui-lin;CHEN Li;LIU Xin-ru(West China Second University Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,Chengdu 610041;West China School of Pharmacy,Sichuan University,Chengdu 610041)
出处
《中南药学》
CAS
2020年第7期1137-1142,共6页
Central South Pharmacy
基金
四川省科技厅项目(No.2019JDR0163)。
