基于FAERS数据库的选择性5‑羟色胺再摄取抑制剂相关胃肠道出血事件的真实世界药物警戒研究  

A real-world pharmacovigilance study of SSRI-associated gastrointestinal bleeding events based on the FDA Adverse Event Reporting System(FAERS)

作　　者：费爱丽 陈倩倩 岳卫清 Fei Aili;Chen Qianqian;Yue Weiqing(Department of Pharmacy,the Second Hospital of Jiaxing/the Second Affiliated Hospital of Jiaxing University,Jiaxing 314000,China;Department of Psychiatry,the Second Hospital of Jiaxing/the Second Affiliated Hospital of Jiaxing University,Jiaxing 314000,China)

机构地区：[1]嘉兴市第二医院/嘉兴大学附属第二医院药学部,浙江嘉兴314000 [2]嘉兴市第二医院/嘉兴大学附属第二医院心理卫生科,浙江嘉兴314000

出　　处：《实用药物与临床》2025年第4期241-246,共6页Practical Pharmacy and Clinical Remedies

基　　金：嘉兴市科技计划项目(2024AD30104)。

摘　　要：目的挖掘和评价选择性5-羟色胺再摄取抑制剂(Selective serotonin reuptake inhibitors,SSRI)与胃肠道出血事件的关联性,为临床安全用药提供参考。方法通过OpenVigil 2.1药物警戒分析工具提取美国FAERS数据库中SSRI类药物相关胃肠道出血事件,提取时间为2003年10月1日至2024年9月30日。利用报告比值比(Reporting odds ratio,ROR)和比例报告比值比(Proportional reporting ratio,PRR)两种方法进行胃肠道出血不良事件信号分析。结果共检索到SSRI类药物相关胃肠道出血事件832份,其中报告最多的为舍曲林(38.1%,317/832),其次分别为西酞普兰(21.9%,182/832)、艾司西酞普兰(16.3%,136/832)、帕罗西汀(11.8%,98/832)和氟西汀(11.4%,95/832),氟伏沙明报告比例最低(0.5%,4/832)。对年龄进行分析,胃肠道出血事件主要发生在65~85岁(36.1%,300/832),其次为<45岁(16.6%,138/832)。对性别进行分析,出血事件主要发生于女性患者(51.3%,427/832),男性患者占比较小(36.4%,303/832)。舍曲林、西酞普兰及氟西汀3种SSRI类药物在胃肠道出血事件中均可生成可疑信号,而帕罗西汀、艾司西酞普兰及氟伏沙明在胃肠道出血不良事件中均未生成可疑信号。结论舍曲林、西酞普兰及氟西汀3种SSRI类药物与胃肠道出血事件具有关联性,其中上消化道出血事件最为普遍。帕罗西汀、艾司西酞普兰及氟伏沙明与胃肠道出血的关联性还需更多的数据支持。Objective To explore and evaluate the association between selective serotonin reuptake inhibitors(SSRIs)and gastrointestinal bleeding events,and to provide reference for the safe clinical use of drugs.Methods Gastrointestinal bleeding events associated with SSRIs were extracted from the US Food and Drug Administration Adverse Event Reporting System(FAERS)by using OpenVigil 2.1 pharmacovigilance analysis tool,and the time of extraction was from October 1,2003 to September 30,2024.Signal analysis of gastrointestinal bleeding events was performed using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.Results A total of 832 SSRI-associated gastrointestinal bleeding events were identified,of which the most reported was sertraline(38.1%,317/832),followed by citalopram(21.9%,182/832),escitalopram(16.3%,136/832),paroxetine(11.8%,98/832),and fluoxetine(11.4%.95/832),and fluvoxamine was the least reported(0.5%,4/832).In terms of age distribution,gastrointestinal bleeding events occurred predominantly in 65~85 years(36.1%,300/832),followed by<45 years(16.6%,138/832).Regarding gender,bleeding events occurred mainly in female patients(51.3%,427/832),and male patients accounted for a lower proportion(36.4%,303/832).All three SSRIs,sertraline,citalopram and fluoxetine generated suspicious signals in gastrointestinal bleeding events,while paroxetine,escitalopram and fluvoxamine did not.Conclusion The three SSRIs sertraline,citalopram and fluoxetine,are associated with gastrointestinal bleeding events,with upper gastrointestinal bleeding events being the most prevalent.More data are needed to support the association of paroxetine,escitalopram and fluvoxamine with gastrointestinal bleeding.

关 键 词：选择性5-羟色胺再摄取抑制剂 不良事件 胃肠道出血 信号挖掘 

分 类 号：R969[医药卫生—药理学]