基于美国食品和药品监督管理局不良事件报告系统数据库仑卡奈单抗安全性风险信号挖掘研究  

Safety risk signal mining study of Lecanemab based on the U.S.Food and Drug Administration adverse event reporting system

作　　者：张书贤 刘格良 莫状 黄泰 贺培凤[4] ZHANG Shuxian;LIU Geliang;MO Zhuang;HUANG Tai;HE Peifeng(School of Management,Shanxi Medical University,Shanxi Province,Taiyuan030002,China;Shanxi Key Laboratory of Big Data for Clinical Decision,Shanxi Medical University,Shanxi Province,Taiyuan030002,China;School of Basic Medical Sciences,Shanxi Medical University,Shanxi Province,Taiyuan030002,China;Institute of Medical Data Sciences,Shanxi Medical University,Shanxi Province,Taiyuan030002,China)

机构地区：[1]山西医科大学管理学院,山西太原030002 [2]山西医科大学临床决策大数据山西省重点实验室,山西太原030002 [3]山西医科大学基础医学院,山西太原030002 [4]山西医科大学医学数据科学研究院,山西太原030002

出　　处：《中国医药导报》2024年第33期8-12,共5页China Medical Herald

基　　金：国家社会科学基金项目(21BTQ050);山西省重点研发计划项目(202102130501003);山西省教育厅研究生教育创新计划各类项目(2023KY372)。

摘　　要：目的基于美国食品和药品监督管理局不良事件报告系统(FAERS)数据库收集仑卡奈单抗相关不良反应(ADR)报告,并计算其风险信号,为临床安全用药提供借鉴。方法从FAERS数据库中收集2023年全年仑卡奈单抗相关ADR,整理归纳后采用报告比数比法、比例报告比值法、贝叶斯可信传播神经网络法和多项伽马-泊松缩量法进行歧化分析,鉴定仑卡奈单抗安全性风险信号。结果本研究从FAERS数据库中共获取仑卡奈单抗相关ADR报告257份,年龄大多数≥65岁(75.1%),女性占比较高(54.1%)。多种算法挖掘后共获取28个首选术语(PT)阳性风险信号。报告数排名前10位的PT除疲劳和嗜睡外均在仑卡奈单抗的药品说明书中被明确标注。此外睡眠质量差、心境抑郁、定向力障碍等精神病类症状、胰腺癌和脑炎等风险信号未在仑卡奈单抗说明书和相关临床试验中提示,尚不能排除与仑卡奈单抗的关联性。结论仑卡奈单抗安全性较好。研究结果显示最相关的ADR已在说明书中提及,建议临床使用仑卡奈单抗时应持续关注精神性疾病症状、胰腺癌和脑炎等风险。Objective To safely guide clinical use,risk signals of Lecanemab-related adverse reaction(ADR)were calculated based on the collection of these ADR reported in the U.S.Food and Drug Administration adverse event reporting system(FAERS)database in this study.Methods Lecanemab-related ADR were collected from the FAERS database for the whole year of 2023.After summary,reporting odds ratio method,proportional reporting ratio method,Bayesian trusted propagation neural network method and multiitem gamma Poisson shrinker method were used for disproportionation analysis to identify the safety risk signals of Lencanizumab.Results A total of 257 reports of Lecanemab-related were obtained from the FAERS database,with the majority of patients older than 65 years(75.1%)and a higher proportion of females(54.1%).A total of 28 preferred terms(PT)positive risk signals were obtained after mining by multiple algorithms.The top 10 reported PTs except fatigue and somnolence were explicitly labeled in the instructions of Lecanemab.In addition risk signals such as poor quality sleep,depressed mood,disorientation and other psychotic symptoms,pancreatic cancer and encephalitis were not suggested in the Lecanemab insert and relevant clinical trials,and an association with Lecanemab cannot yet be excluded.Conclusion The results of the study show that the most relevant ADR are already mentioned in the instructions,and it is recommended that clinical use of Lecanemab should be accompanied by ongoing attention to the risks of psychiatric symptoms,pancreatic cancer,and encephalitis.

关 键 词：仑卡奈单抗 阿尔茨海默病 药物警戒分析 不良反应风险信号 

分 类 号：R969.3[医药卫生—药理学]