首页|基于FAERS数据库的替尔泊肽不良事件风险信号的数据挖掘

基于FAERS数据库的替尔泊肽不良事件风险信号的数据挖掘

扫码查看
目的 基于美国食品药品监督管理局药品不良事件报告系统(FAERS)对替尔泊肽(Tirzepatide)不良事件(ADE)的发生状况进行数据挖掘,为替尔泊肽的临床安全用药提供参考。方法 从FAERS数据库调取2022年第一季度至2023年第二季度数据,提取替尔泊肽相关 ADE报告,应用报告比值比法(ROR)和英国药品和保健品管理局综合标准法(MHRA)对风险信号进行检测。结果 共获取14 683份替尔泊肽相关ADE报告并检测得到有效信号132个,共涉及16个系统器官分类(SOC),其中报告例次位于前3的为各类损伤、中毒及操作并发症(9 049例,38。20%),全身性疾病及给药部位各种反应(6 214例,26。23%),胃肠系统疾病(5 839例,24。65%)。132个有效信号中有108个药品不良反应(ADR)信号,累及15个SOC,信号强度排前3位的ADR是注射部位发凉(ROR=101。47)、注射部位损伤(ROR=76。17)和饥饿(ROR=53。75)。共有47个ADR信号和5个SOC尚未被说明书记载。结论 在替尔泊肽的临床应用中,应重点关注注射部位反应和胃肠系统疾病的ADE,为有效开展药学服务和及时处理有关 ADR提供依据。
Signal Data Mining of Adverse Events of Tirzepatide Based on FAERS
Objective To mine signals of adverse events(ADEs)of tirzepatide in order to provide a reference for safe drug use in clinic.Methods Data of ADEs associated with tirzepatide collected from the first quarter of 2022 to the second quarter of 2023 was extracted from FAERS database and analyzed using the reporting odds ratio method and Medicines and Healthcare Products Regulatory Agency(MHRA)meth-od.Results Totally,14 863 reports of adverse events with tirzepatide as the target drug were collected,and 132 valid signals were detected,involving 16 system organ classes(SOCs).The top three reported cases included injury,poisoning and procedural complications in 9049 cases(38.20%),general disorders and administration site conditions in 6214 cases(26.23%)and gastrointestinal systemic diseases in 5839 cases(24.65%).A total of 108 adverse drug reaction(ADR)signals related to 15 SOCs were identified,and the top three ADRs in signal intensity were injection site coldness(ROR=101.47),injection site injury(ROR=76.17)and starvation(ROR=53.75).A total of 47 signals and 5 SOCs were not mentioned in the latest label.Conclusion Injection site reactions and gastronintestinal disorders are worthy of attention in clinical applications of tirzepatide,which can provide a reference for effective pharmaceutical care and quick treatment of adverse reactions.

Tirzepatideadverse drug eventsreporting odd ratio methoddata mining

戴小霞、欧阳山丹、范华强、谢丽芬、郝晓伟

展开 >

361001 福建厦门,陆军第73集团军医院

替尔泊肽 不良事件 比值比法 数据挖掘

2024

解放军药学学报
中国人民解放军总后勤部卫生部 药品仪器检验所

解放军药学学报

影响因子:0.529
ISSN:1008-9926
年,卷(期):2024.37(6)