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RSS基于FAERS数据库的他克莫司心血管系统不良事件信号挖掘
Signal Mining of Tacrolimus-related Cardiovascular Adverse Events based on the US FAERS database
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摘要: 目的 基于国际权威数据库挖掘他克莫司相关的心血管系统不良事件信号，以期为临床安全用药提供参考。方法 检索并提取美国食品药品监督管理局不良事件报告系统（Food and Drug Administration Adverse Event Reporting System，FAERS）数据库中2004年1月1日—2024年9月30日以他克莫司为首要怀疑药物的不良反应报告，重点关注心血管系统不良事件。采用监管活动医学词典中的系统器官分类（system organ class，SOC）和首选语（preferred term，PT）对不良事件进行归类，并采用药物不良反应信号信息标准值、经验贝叶斯几何均值、报告比值比法对心血管系统相关药物不良事件（adverse drug event,ADE）进行信号挖掘。结果 经检索，获得以他克莫司为首要怀疑药物的ADE报告58357份，其中与心血管系统疾病相关3173份。发生频率居前5位的心血管系统不良事件分别是高血压、心脏骤停、心力衰竭、心肌梗死、心房颤动；经AED信号检测发现，他克莫司与高血压、心脏骤停、心力衰竭、心室肥厚、心肌病、心肌肥大存在相关性。在心血管系统不良事件预后方面，以“需住院治疗或延长住院时间”最为常见（34.74%）；其次为“死亡”（29.44%）。结论 他克莫司具有引起多种心血管疾病的风险。临床应用他克莫司时，需结合患者的基础疾病及合并用药情况，密切关注其用药初期及长期用药过程中的不良反应，及时调整药物剂量，以保障患者长期用药安全。Abstract: Objective: To explore signals related to tacrolimus-induced cardiovascular adverse events using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), providing references for the drug's safe use in clinical practice. Methods: Tacrolimus-induced adverse drug events (ADEs) were extracted from the FAERS database between 1 January 2004 and 30 September 2024. The ADEs were categorised using the System Organ Classification (SOC) and Preferred Term (PT) in the Medical Dictionary for Regulatory Activities (MedDRA), and analysed using the ratio of reported values (RRV) method to identify ADE signals. Results: There was a correlation between tacrolimus and hypertension, cardiac arrest, cardiac failure, ventricular hypertrophy, cardiomyopathy， andcardiac hypertrophy. Conclusion: It is suggested that tacrolimus has cardiovascular-related disease risk. When clinically applied, tacrolimus should be combined with the patients' underlying diseases and co-administration of drugs, closely monitor its adverse reactions, and adjust the dosage in time to ensure the safety of long-term use of drugs for patients.
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