摘要
目的了解英克司兰不良事件(AE)风险,为临床安全应用该药提供参考。方法收集美国FDA不良事件报告系统(FAERS)数据库2004年第4季度至2023年第2季度以英克司兰为首要怀疑药物的AE报告,采用《国际医学用语词典》26.0版的首选术语(PT)与系统器官分类(SOC)对AE进行标准化和分类。采用报告比值比(ROR)法与英国药品和保健产品管理局(MHRA)综合标准法进行AE风险信号挖掘,将同时满足报告数≥3且ROR的95%置信区间(CI)下限>1(ROR法)和报告数≥3、PRR≥2且χ^(2)≥4(MHRA综合标准法)的PT视为AE风险信号,并对其进行描述性统计分析。结果共收集到以英克司兰为首要怀疑药物的AE报告1888份,涉及1888例患者和835个PT。AE的上报国家以美国为主(88.7%,1675/1888),报告者以消费者为主(62.1%,1171/1886);严重AE报告共484例(25.6%)。剔除非药品及适应证相关PT,同时满足ROR法与MHRA综合标准法风险信号判定标准的PT共85个,累及15个SOC。报告数排名前5位的PT为关节痛(248例)、注射部位痛(237例)、肢体疼痛(170例)、肌痛(158例)和腹泻(132例);信号强度排名前5位的PT包括膀胱不适(ROR=28.87,PRR=28.85)、注射部位不适(ROR=24.48,PRR=24.40)、鼻窦疼痛(ROR=23.20,PRR=23.19)、注射部位囊泡(ROR=17.63,PRR=17.61)、注射部位皮疹(ROR=12.51,PRR=12.45)。分别以报告数和信号强度排名前20位的PT中,有8个和13个PT未在国内外药品说明书记载,其中肌痛、听觉减退的报告数较多且信号强度较强。结论美国FAERS数据库英克司兰AE主要为注射部位反应,其次还有关节痛、肌痛、肌痉挛等肌肉骨骼相关AE,以及尿路感染、支气管炎等感染相关AE,需要临床关注。
Objective To investigate the risk of adverse event(AE)associated with inclisiran and to provide reference for the safe use in clinical practice.Methods The AE reports in the US FDA Adverse Event Reporting System(FAERS)database from the 4th quarter of 2004 to the 2nd quarter of 2023 with inclisiran as the primary suspect drug were collected.AE was standardized and classified using the preferred terminology(PT)and the system organ class(SOC)of the Medical Dictionary for Regulatory Activities 26.0.AE risk signal mining was performed using the report odds ratio(ROR)method and the UK Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard method.PT that was considered as an AE risk signal in both methods were defined as AE risk signals[ROR method:≥3 reports and the lower limit of the 95% confidence interval(CI)of the ROR>1;MHRA comprehensive standard method:≥3 reports、PRR≥2 and χ^(2)≥4].A descriptive statistical analysis was performed.Results A total of 1888 AE reports were collected with inclisiran as the primary suspect drug,involving 1888 patients and 835 PTs.The AE was predominantly reported in the United States(88.7%,1675/1888),and predominantly by the consumer(62.1%,1171/1886);there were a total of 484 reports(25.6%)about serious AE.Excluding non-drug and indication-related PTs,85 PTs(involving 15 SOCs)met the criteria in both the ROR method and the MHRA comprehensive standard method,and defined as AE risk signals.The top 5 PTs ranked by the number of reports were arthralgia(248 cases),injection site pain(237 cases),limb pain(170 cases),myalgia(158 cases),and diarrhea(132 cases);the top 5 PTs ranked by the signal intensity included bladder discomfort(ROR=28.87,PRR=28.85),injection site discomfort(ROR=24.48,PRR=24.40),sinus pain(ROR=23.20,PRR=23.19),injection site vesicles(ROR=17.63,PRR=17.61),and injection site rash(ROR=12.51,PRR=12.45).Among the top 20 PTs ranked according to the number of reports and signal intensity respectively,8 and 13 PTs were not documented in domestic a
作者
王兴龙
胡卿源
白洁
宋智慧
Wang Xinglong;Hu Qingyuan;Bai Jie;Song Zhihui(Department of Pharmacy,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China)
出处
《药物不良反应杂志》
CSCD
2024年第4期223-228,共6页
Adverse Drug Reactions Journal
基金
北京药学会临床药学研究项目(LCYX-2022-14)。
