基于FAERS的第三代芳香化酶抑制剂与肌腱疾病事件的关联性分析  

Analysis of correlation between third-generation aromatase inhibitors and tendon disease events based upon FAERS

作　　者：黄光明 沈小菊 刘国萍[1] 赵敏 HUANG Guangming;SHEN Xiaoju;LIU Guoping;ZHAO Min(Department of Pharmacy,First Affiliated Hospital,Guangxi Medical University,Guangxi Nanning 530021,China)

机构地区：[1]广西医科大学第一附属医院药学部,广西南宁530021

出　　处：《中国医院药学杂志》2024年第24期2899-2903,共5页Chinese Journal of Hospital Pharmacy

基　　金：广西卫健委自筹课题项目(编号:Z20210980);广西中医药管理局自筹课题项目(编号:GXZYA20230250)。

摘　　要：目的:挖掘和评价第三代芳香化酶抑制剂(aromatase inhibitors,AIs)与肌腱疾病事件的关联性,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数据库中第三代AIs相关肌腱疾病事件,提取时间范围为2004年6月至2023年8月2日。利用报告比值比法(reporting odds ratio,ROR)和比例报告比值法(proportional reporting ratio,PRR)进行肌腱疾病事件信号分析。结果:共检索到第三代AIs相关肌腱疾病事件468份,阿那曲唑、来曲唑、依西美坦分别为197、188、83份,其中肌腱炎事件最多,占所有肌腱疾病事件58.77%(275/468)。AIs相关肌腱疾病事件年龄构成上,40~64岁33.76%(158/468),65~85岁28.41%(133/468),性别构成上女性占比高于男性。信号结果显示肌腱炎和腱鞘炎在3种AIs中均可生成可疑信号,强度排序为分别为阿那曲唑>来曲唑>依西美坦、阿那曲唑>依西美坦>来曲唑;肌腱断裂在3种AIs中未形成可疑信号;肌腱疼痛在阿那曲唑中可生成一个可疑信号。结论:3种AIs与肌腱炎、腱鞘炎的肌腱疾病事件具有关联性,与肌腱断裂的关联性还需更多的数据支持。OBJECTIVE To explore the association of third-generation aromatase inhibitors(AIs)with tendon disease events,and provide references for clinical safety of drug use.MEHODS AIs-related tendon disease events were extracted from the FAERS database by OpenVigil 2.1 pharmacovigilance analysis tool from June 2004 to August 2,2023.The event signals of tendon disease were analyzed by reporting odds ratio(ROR)and proportional reporting ratio(PRR).RESULTS A total of 468AIs-related tendon disease events were found.And 197,188,83 were associated with anastrozole,letrozole and ethemetane.Tendinitis events were the most common,accounting for 58.77%(275/468)of all tendon disease events.And 33.76%(158/468)of AIs-related tendon disease events occurred between 40-64 years of age and 28.41%(133/468)occurred between 65-85years of age.In terms of gender composition,females were higher than males.Signal results showed that tendinitis and tenosynovitis could generate suspicious signals in three AIs and the intensity was ranked as anastrozole>letrozole>exemestane and anastrozole>exemestane>letrozole respectively.Tendon rupture did not produce a suspicious signal in three AIs while tendon pain caused a suspicious signal in anastrozole.CONCLUSION Three AIs are associated with tendinitis and tenosynovitis while the correlation with tendon rupture requires more data support.

关 键 词：芳香化酶抑制剂 肌腱疾病 不良反应 信号挖掘 

分 类 号：R979.5[医药卫生—药品]