替尔泊肽不良事件信号挖掘与分析

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中图分类号R969.3；R587 文献标志码A 文章编号 1001-0408（2025）08-0956-05

DOI 10.6039/j.issn.1001-0408.2025.08.11

Signal mining and analysis of adverse drug events of tirzepatide

XIE Zeyu'，LIANG Zhuoru'，ZHENG Guimei，CAO Weiling，CHEN Jisheng2（1. Dept. of Pharmacy， Shenzhen Luohu People's Hospital， Guangdong Shenzhen 5180Oo， China；2. Key Specialty of Clinical Pharmacy， the First Affiliated Hospital of Guangdong Pharmaceutical University， Guangzhou 510o80， China）

ABSTRACTOBJECTIVEToidentify andanalyzeadversedrug event（ADE）signalsassciatedwithtirzepatidebasedonthe FDAAdverse Event Reporting System（FAERS）database，providingareference forclinicalmedication safetyMETHODS ADE reportsfromJanuaryl，2022，toJune302024，withtirzepatideastheprimarysuspecteddrug，wereextractedfromtheFAERS databae.MedicalDictionaryforRegulatoryActivitieswasusedtosystematicallycategorizetheselectedsystemorganclass（SOC） and preferredtermofADE.Signalmining andanalysis were performedusingthereportingoddsratiomethodandthepropotional reportingratiomethodRESULTSAtotalof39229ADEreportsrelatedtotirzepatidewerebtained，including3934severe ADE reports（ 10.03% ）. The majority of severe ADE reports were related to hospitalization or prolonged hospitalization（ 3.82% ， involving l3l positiveADE signals.Among thereportswithdocumented patient gender andage，26195 were female 66.77% ， 7 869 were male （20.06%） ，and the majority of patients were aged 18-64 years！ （54.26%） . The top three most frequently reported ADEwere injection site pain，nausea，and injection sitehemorrhage.Strong ADE signalsnot mentioned inthe tirzepatide instructinincludedinjectionsitecoldnessstarvationketoacidosis，injectionsitehemorhage，hungerelevatedadrenaline， injection siteskincracking，bingeeating，skinlaxityintestinalsepsis，lackofsatietyanddysesthesiaSubgroupanalysis for patint'genderandageshoweddiffrencesintheproportionofADEreportsacrossdiffrentSOC.Malepatientsorthoseaged ？65 years had a higher risk of gastrointestinal system disorders compared to female patients or those aged <65 years. CONCLUSIONS InclinicaluseoftirzepatideinaditiontomonitoringADElistedintheinstructionatentionshouldalsobepaidtoADEnot mentionedintheinstruction，suchasinjectionsitecoldness，starvationketoacidosis，injectionsitehemorrhage，elevated adrenaline， and intestinal sepsis， to ensure patient safety.

KEYWORDS tirzepatide； FDA Adverse Event Reporting System； adverse drug event； signal mining

2型糖尿病约占全球糖尿病的 98% ，研究显示，中国20～79 岁成人糖尿病患病率由1990年的 4.7% 上升到2019年的 8.0% ，增长了 70.2% ；与2019年相比，预计2020-2030 年，中国 20～79 岁成年人的糖尿病患病率将从 8.0% 上升到 。（剩余7456字）