基于FDA不良事件报告系统数据库的英克司兰相关不良反应信号比值失衡分析  

Disproportionality analysis of adverse reaction signals related to Inclisiran based on FDA Adverse Event Reporting System database

作　　者：贾晓丽 王宏彦 刘瑞玲 徐晓艳[1] 陈其玲[1] JIA Xiaoli;WANG Hongyan;LIU Ruiling;XU Xiaoyan;CHEN Qiling(Department of Pharmac,Liaocheng people's Hospital Brain hospital,Shandong Liaocheng 252000,China)

机构地区：[1]聊城市人民医院脑科医院药剂科,山东聊城252000

出　　处：《临床药物治疗杂志》2024年第11期79-83,共5页Clinical Medication Journal

摘　　要：目的 基于FDA不良事件报告系统(FAERS)数据库获取英克司兰相关药品不良反应(ADE)信号,为临床使用提供参考。方法 通过OpenVigil 2.1数据平台分析工具,提取2021年1月至2023年12月与克司兰相关的不良事件报告记录。使用报告比值比法(ROR)、比例报告比值法(PRR)和报告频次筛选英克司兰安全警戒信号,并对风险信号首选术语(PT)进行统计分析和系统分类。结果 共收集到2856例英克司兰相关ADE报告,其中女性占比较男性高(51.09%比37.18%),年龄主要集中在60~80岁(34.56%),以美国上报例数最多(2499例,87.50%)。涉及1004类ADE报道,筛选出136个有效信号,涉及15个系统器官分类,主要包括全身性疾病和给药部位各种反应、各种肌肉骨骼及结缔组织疾病、各类检查等。不良反应报告例数排名前3位的PT为注射部位痛、关节痛、肢体疼痛;信号强度排名前3位的PT为脂蛋白升高、脂蛋白(a)升高、低密度脂蛋白升高。发现多项说明书未提及信号,如:肌痛、肢体疼痛、腹泻、疲劳、呼吸困难等。对源自中国的20例报告进行分析,发现血糖升高、肝功异常报告频次较多。结论 除说明书中不良反应外,应关注英克司兰在各种肌肉骨骼及结缔组织疾病、各类检查、胃肠系统疾病等方面的不良反应。中国人群还应关注肝功异常、血糖升高等相关不良反应。Objective The objective of this study is to assess the risk of adverse drug reaction(ADR)associated with Inclisiran from the US Food and Drug Administration Adverse Event Reporting System(FAERS),so as to provide clinical guidance.Methods The OpenVigil 2.1 website was utilized to extract records of reported adverse events associated with Inclisiran from Q12021 to Q42023.The reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method,and frequency were employed to identify safety warning signals of Inclisiran.Preferred terms(PTs)for risk signals were statistically analyzed and systematically classified.Results A total of 2856 cases of Inclisiran-related adverse drug events(ADEs)were collected.The proportion of females was higher than that of males(51.09%vs 37.18%),and the age range of patients was predominantly between 60 and 80 years old(34.56%%).Among the 1004 ADEs reported,136 effective signals were identified,involving 15 System Organ Classes(SOCs).The primary categories included general disorders and administration site conditions,musculoskeletal and connective tissue disorders,and investigations.The top three PTs by number of reports were injection site pain,arthralgia,and pain in extremity.The PTs with the highest signal strength were lipoprotein increased,Lipoprotein(a)increased,low density lipoprotein increased.This signal mining analysis revealed several signals not mentioned in the instructions such as myalgia,pain in extremity,diarrhoea,fatigue,dyspnoea etc.Analysis of 20 reports from China found that elevated blood glucose and abnormal liver function were frequently reported.Conclusion In addition to the adverse reactions in the instructions,attention should be given to potential adverse reactions associated with Inclisiran in musculoskeletal and connective tissue disorders,investigations,gastrointestinal disorders.For Chinese individuals,close attention should be given to abnormal hepatic function and elevated blood glucose levels.

关 键 词：英克司兰 FDA不良事件报告系统数据库(FAERS) 不良事件 比值失衡法 

分 类 号：R969.3[医药卫生—药理学] R972.6[医药卫生—药学]