基于美国FAERS数据库的利培酮不良事件信号挖掘与分析  

Mining and analysis of risperidone adverse event signals based on FAERS database

作　　者：黄玲[1] 王凤玲 陈力[1] 王新茗 陈力[2] HUANG Ling;WANG Fengling;CHEN Li;WANG Xinming;CHEN Li(Dept.of Pharmacy,the First Affiliated Hospital of Chengdu Medical College,Chengdu 610500,China;Dept.of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,China)

机构地区：[1]成都医学院第一附属医院药学部,成都610500 [2]四川大学华西第二医院药学部,成都610041

出　　处：《中国药房》2023年第3期350-354,共5页China Pharmacy

基　　金：四川省科技计划项目(No.2019JDR0163);四川省医学(青年创新)科研课题(No.Q21072)。

摘　　要：目的 为利培酮的临床安全使用提供参考。方法 采用报告比值比法与英国药品和保健品管理局综合标准法,对美国FDA不良事件报告系统(FAERS)数据库中2017年第1季度至2021年第3季度共19个季度的利培酮相关药品不良事件(ADE)报告进行数据挖掘与分析。结果 获得以利培酮为首要怀疑药物的ADE报告共计101 181份,涉及患者33 179例。所统计的报告中,男女比约为6.21∶1;以<18岁的患者居多(占15.01%);上报ADE者主要为消费者(占69.74%),上报国家主要为美国(占79.72%);使用口服剂型的患者最多(占83.71%)。共产生ADE信号409个,包括男性乳腺发育、假性男性乳房发育症、体质量异常增加、高催乳素血症和Wellens综合征等;涉及26个系统器官分类,主要为生殖系统及乳腺疾病,各类损伤、中毒及操作并发症,精神病类,代谢及营养类疾病,各类神经系统疾病等。结论 利培酮常见ADE信号及其累及系统器官与说明书基本一致,但也要警惕其说明书中未记载的ADE,如Wellens综合征、纤维增生性心内膜炎、门静脉海绵样变性、兔子综合征等。OBJECTIVE To provide reference for safe use of risperidone in clinic. METHODS Data mining and analysis of risperidone-related adverse drug event(ADE) reports from the first quarter of 2017 to the third quarter of 2021 in the United States FAERS database were carried out using reported odds ratio and composite criteria methods from Medicines and Healthcare Products Regulatory Agency. RESULTS There were 101 181 ADE reports with risperidone as the primary suspect drug,involving a total of 33 179 patients. Among those reports,the male-to-female ratio was about 6.21 to 1;most of them were <18 years old(15.01%);ADE was mainly reported by consumers(69.74%) and mainly reported by the United States(79.72%);oral dosage form was the most used,accounting for 83.71%. A total of 409 ADE signals were obtained,including male breast development,pseudogynecomastia,abnormal increase in body mass,hyperprolactinemia and Wellens syndrome,etc. Twenty-six systems and organs were involved,mainly including reproductive system and breast diseases,various injuries,poisoning and operational complications,mental diseases,metabolic and nutritional diseases,and various nervous system diseases,etc. CONCLUSIONS The common ADE signals of risperidone and the system involved are consistent with the instructions,but we should also be alert to the ADE not recorded in the instruction,such as Wellens syndrome,fibroproliferative endocarditis,cavernous degeneration of portal vein,rabbit syndrome,etc.

关 键 词：利培酮 药品不良事件 信号 数据挖掘 药品不良反应 

分 类 号：R969.3[医药卫生—药理学] R971[医药卫生—药学]