基于美国FAERS数据库的利拉鲁肽和司美格鲁肽不良事件信号挖掘与分析  

Adverse Event Signals of Liraglutide and Semaglutide Based on the FAERS Database

作　　者：钟玲 曾慧妍 袁鑫 王颖彦 ZHONG Ling;ZENG Huiyan;YUAN Xin;WANG Yingyan(Department of Pharmacy,the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou Guangdong 510120,China;Department of Endocrinology,the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou Guangdong 510120,China)

机构地区：[1]广州中医药大学第二附属医院药学部,广东广州510120 [2]广州中医药大学第二附属医院内分泌科,广东广州510120

出　　处：《中国药物警戒》2025年第3期305-312,共8页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82304905);省部共建中医湿症国家重点实验室项目开放课题(SZ2022KF12)。

摘　　要：目的挖掘对比利拉鲁肽、司美格鲁肽上市后的不良事件信号,为临床安全用药提供参考。方法采用报告比值比(Reporting Odds Ratio,ROR)法,比例报告比值比(Proportional Reporting Ratio,PRR)法,信息成分(Information Component,IC)法及多项伽马-泊松分布缩减(Muti-item Gamma Poisson Shrinker,MGPS)法,对美国食品药品监督管理局(Food and Drug Administration,FDA)不良事件报告系统(Adverse Event Reporting System,FAERS)数据库中,2010年1月1日至2024年3月31日利拉鲁肽及司美格鲁肽的不良事件数据进行挖掘,筛选阳性及肿瘤相关信号进行对比分析。结果利拉鲁肽共挖掘得到阳性信号175个,涉及20个系统-器官分类(SOC)。司美格鲁肽共挖掘得到231个阳性信号,涉及21个SOC。两者不良事件均主要涉及胃肠系统和代谢及营养类疾病。肿瘤方面,均以甲状腺及胰腺相关肿瘤为主,且肿瘤相关不良事件发生的最大占比时间均位于大于360 d时间段。利拉鲁肽与甲状腺肿瘤、胰腺肿瘤及胰腺炎相关不良事件的关联性更强且累及病例数量更多。司美格鲁肽在痛觉、皮肤等感觉异常及眼器官相关不良事件方面更为突出。结论利拉鲁肽和司美格鲁肽在药品不良反应方面具有一定的共性及特性,临床可根据药物特点及患者基础情况,进行个性化选择用药。同时,建议相关说明书对的可能性给予一定的警示或说明。Objective To mine and compare signals of post-marketing adverse events of liraglutide and semaglutide in order to provide references for safe and rational use.Methods Data on adverse events reported by the Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)between January 1,2010 and March 31,2024 was mined using the reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method,information component(IC)method,and the muti-item gamma poisson shrinker(MGPS)method.Positive signals and tumor related signals were screened out and compared.Results 175 positive signals related to liraglutide were mined,involving 20 systems organs class(SOC),compared with 231 for semaglutide,involving 21 SOC.The adverse events manifested themselves as gastrointestinal disorders,metabolism and nutrition disorders.In terms of tumors,thyroid and pancreatic related tumors were dominating and onset of symptoms in most of the cases was after 360 days.Liraglutide was more significantly correlated with such adverse events as thyroid tumors,pancreatic tumors,and pancreatitis while semaglutide was likely to cause adverse events related to eyes and the skin.Conclusion Liraglutide and semaglutide can cause similar adverse drug reactions,so clinicians are advised to opt for personalized medications while warnings about the possibility of pancreatic tumors should be given in related instructions.

关 键 词：利拉鲁肽 司美格鲁肽 美国FAERS数据库 报告比值比 比例报告比值比 信息成分法 多项伽马-泊松分布缩减法 胰腺肿瘤 药品不良事件 

分 类 号：R798.1[医药卫生—临床医学] R743