索非布韦神经精神不良反应的信号挖掘  

Signal Mining of Neuropsychic Adverse Drug Reactions by Sofosbuvir

作　　者：王宇[1] 饶友义[1] 宁红[1] 寇国先[2] 杨勇[3] WANG Yu;RAO Youyi;NING Hong;KOU Guoxian;YANG Yong(Department of Pharmacy, Mianyang Central Hospital, Sichuan Province, Mianyang 621000, China;Department of Infection, Mianyang Central Hospital, Mianyang 621000 , China;Department of Pharmacy, the People's Hospital of Sichuan Province, Chengdu 610041, China)

机构地区：[1]四川省绵阳市中心医院药剂科,绵阳621000 [2]四川省绵阳市中心医院感染科,绵阳621000 [3]四川省人民医院药学部,成都610041

出　　处：《医药导报》2019年第5期663-667,共5页Herald of Medicine

摘　　要：目的对索非布韦不良反应进行信号挖掘,为临床安全用药提供参考。方法采用报告比值比法(ROR法)对美国不良事件报告系统(AERS) 2014—2015年第二季度索非布韦引起的神经精神不良反应报告进行信号挖掘,分析信号在患者的性别、年龄和剂量中的分布。结果共挖掘出52个相关不良反应信号,其中49个尚未被说明书收录。ROR值相对较大的不良反应信号为精神障碍(13.49)、宿醉(11.36)、易怒(12.40)、杀人冲动(13.93)、暴力倾向(13.37)等,所有不良反应信号均较弱。上述信号在性别中分布差异无统计学意义(P=0.227),在年龄(P=0.000)及用药剂量(P=0.001)中差异有统计学意义。结论对索非布韦不良反应信号挖掘可初步为评价其安全性提供参考。Objective To provide reference for clinical rational drug use via signal mining of the side effects of sofosbuvir. Methods The warning signals of sofosbuvir-induced neuropsychic adverse drug reaction (ADR) were mined by proportional reporting ratio(ROR)method from Adverse Event Reporting System in the United States from 2014 to the second quarter of 2015 were mined by proportional repoting ratio (ROR) method. The distribution characteristic of signals, such as gender, age and dosage, were analyzed. Results A total of 52 relevant ADR signals were detected, and 49 were not recorded in the drug label. The ROR of ADR signals which were higher than others were mental disorders (13.49), hangover (11.36), irritability (12.40), homicidal ideation (13.93), violence-related symptom (13.37). The strengths of signals were all weak. There was no significant difference in the distribution of gender ( P = 0.227), however, there were significant differences in the in the distribution of patient age ( P <0.001) and sofosbuvir dosage ( P =0.001). Conclusion Mining and analysis of ADR signals induced by sofosbuvir can provide preliminary references to evaluate the safety.

关 键 词：索非布韦 不良反应 神经精神系统 信号挖掘分析 

分 类 号：R978.7[医药卫生—药品] R969.3[医药卫生—药学]