睾酮治疗相关严重不良事件分析  

Analysis of serious adverse events related to testosterone treatment

作　　者：赵晖 颜明明 张千 邱晓燕 钟明康 ZHAO Hui;YAN Mingming;ZHANG Qian;QIU Xiaoyan;ZHONG Mingkang(Department of Pharmacy,Huashan Hospital of Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院药剂科,上海200040

出　　处：《世界临床药物》2024年第2期119-127,共9页World Clinical Drug

摘　　要：目的基于美国FDA不良事件报告系统数据库探讨睾酮替代疗法(testosterone replacement therapy,TRT)相关严重不良反应。方法运用报告比值比(reporting odds ratio,ROR)法和贝叶斯置信传播神经网络模型,分析数据库中2004年1月至2023年6月的不良反应报告。结果筛选出16702例睾酮使用者进行分析,可得到424个药物警戒信号,其中155个为较强信号,涉及心血管、生殖、神经以及内分泌等29个系统器官。包括红细胞增多症[ROR 149.10,95%CI 128.65~172.80,信息组件下限(lower limit of information component,IC_(025))6.05]、睾丸萎缩(ROR 114.47,95%CI 89.88~145.79,IC_(025)4.92)、肾透明细胞癌(ROR 86.97,95%CI 64.47~117.32,IC_(025)4.23)及急性心肌梗死(ROR 20.40,95%CI 18.77~22.17,IC_(025)4.14)等。结论TRT相关的严重不良反应主要为血栓形成、严重的心血管事件以及肿瘤风险,显著增加致死率和致残率。医务工作者应重视TRT潜在的严重不良反应风险,平衡其获益与风险。Objective To investigate the association between testosterone replacement therapy(TRT)and serious adverse events,based on the FDA adverse event reporting system(FAERS)database.Method Reporting odds ratio(ROR)and Bayesian confidence propagation neural network were applied to analyze the adverse reaction reports in FAERS database from January 2004 to June 2023.Result A total of 16702 testosterone users were included according to the including/excluding criteria,and 424 pharmacovigilance signal were detected,among which 155 were strong signals,referring to 29 system organ classes,such as cardiovascular,reproductive,nervous and endocrine systems.The most significant adverse events including polycythemia[ROR 149.10,95%CI 128.65—172.80,lower limit of information component(IC_(025))6.05],testis atrophy(ROR 114.47,95%CI 89.88—145.79,IC_(025)4.92),clear cell renal cell carcinoma(ROR 86.97,95%CI 64.47—117.32,IC_(025)4.23),and acute myocardial infarction(ROR 20.40,95%CI 18.77—22.17,IC_(025)4.14).Conclusion The serious adverse reactions associated with TRT were mainly thrombosis,serious cardiovascular events and tumor risk,which significantly increased the mortality and disability rate.Health care workers should pay more attention to the potential risk of TRT-related erious adverse events and balance the benefits and risks.

关 键 词：药物警戒 睾酮 不良反应 严重心血管事件 血栓 数据挖掘 

分 类 号：R977.1[医药卫生—药品]