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基于FDA不良事件报告系统数据库对非布司他血栓栓塞风险信号的分析
Risk of Thromboembolic Events in Febuxostat: Data Analysis Based on FDA Adverse Event Reporting System
  
DOI:
中文关键词:  非布司他  别嘌醇  药品不良事件  血栓栓塞事件  美国食品药品管理局不良事件报告数据库
英文关键词:Febuxostat  Allopurinol  Adverse drug events  Thromboembolic events  FDA adverse event reporting system
基金项目:
作者单位
钟国冬1 张翼2,3 方振威2 王亚力4 张茹2,3 1.嘉善县第一人民医院药剂科 浙江嘉兴 3141002.首都医科大学附属北京安贞医院药事部3.首都医科大学药学院4.汕头大学医学院第一附属医院药学部 
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中文摘要:
      摘 要 目的:以别嘌醇为对照分析并评价非布司他致心血管血栓栓塞事件发生情况,为临床用药安全提供参考。方法:调取美国食品药品管理局(FDA)不良事件报告系统数据库(FAERS)中非布司他和别嘌醇相关不良事件(ADE)报告,检索时限为2004年1月1日~2018年12月31日。通过报告比值比(ROR)对比非布司他的心血管血栓栓塞事件发生情况。结果:纳入的8 447 806份ADE报告中,以非布司他为首要怀疑药物的报告5 953份,以别嘌醇为首要怀疑药物的报告72 569份。非布司他致心血管血栓栓塞事件390例,别嘌醇5 917例。非布司他对比别嘌醇致血栓栓塞及死亡事件[ROR=1.08,95%CI(0.96,1.22)]、非致死性血栓栓塞事件 [ROR=0.87,95%CI(0.74,1.03)]、卒中[ROR=1.23,95%CI(0.75,2.01)]、心肌梗死[ROR=0.77,95%CI(0.59,1.00)]、其他血栓栓塞事件[ROR=0.92,95%CI(0.73,1.16)]风险的差异无统计学意义;非布司他对比别嘌醇致全因死亡风险的差异有统计学意义[ROR=1.37,95%CI(1.16,1.61)],提示非布司他每导致1例ADE,该病例的死亡风险比别嘌醇高37%。结论:与别嘌醇相比,非布司他增加了报告患者的全因死亡风险,但并未增加患者的非致死性血栓栓塞事件风险。本研究主要结局与此前研究基本一致,仍需要后续研究对其关联性进一步验证。
英文摘要:
      ABSTRACT Objective:To evaluate the risk of cardiovascular thromboembolic events in febuxostat, and to provide a reference for clinical drug safety. Methods:Adverse events reporting of febuxostat and allopurinol from January 1, 2004 to December 31, 2018 were retrieved from the FDA adverse event reporting system. Comparison of februated cardiovascular thromboembolic events by reported odds ratio (ROR). Results: A total of 8 447 806 ADE reports were retrieved, of which 5 953 were febuxostat as the primary suspect drug, 72 569 were allopurinol as the primary suspect drug, 390 were cardiovascular thromboembolic events, and 5 917 were allopurinol. The ROR value of cardiovascular thromboembolic events was 1.08(95%CI 0.96 to 1.22), the non fatal thromboembolic event ROR was 0.87(95%CI 0.74 to 1.03), and the stroke ROR was 1.23(95%CI 0.75 to 2.01). Myocardial infarction ROR value 0.77(95%CI 0.59 to 1.00) and other thromboembolic events ROR value 0.92(95%CI 0.73 to 1.16). It is worth noting that the ROR value for all cause mortality was 1.37(95%CI 1.16 to 1.61), which was statistically significant. This indicates that for every ADE in the case of febuxostat, the risk of death in this case was 37% greater than that of allopurinol. Conclusion:Febuxostat increased the risk of all cause mortality in reported patients compared with allopurinol, but did not increase the risk of non fatal thromboembolism in patients. Although the main outcome of this study is basically consistent with previous studies, the reliability of this result still needs to be verified by subsequent studies.
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