目的:分析奥沙利铂导致过敏反应药品不良事件(adverse drug event，ADE)发生特点和临床表现，为该药临床安全应用提供参考。方法:利用OpenVigil 2。1工具从美国FAERS数据库收集奥沙利铂的过敏反应ADE报告，筛选后统计患者的基本信息、ADE发生时间、症状、结局及药物联用情况，并利用Apriori关联规则算法方法探究不良事件发生的关联情况。结果:收集到以奥沙利铂为主要怀疑的过敏反应报告2 195份，年龄主要分布在60岁以上，发生国家以美国及其他欧洲国家为主，常见于结直肠肿瘤患者;最常见的ADE发生在0～1d，症状伴随呼吸困难、超敏反应等，结局多为延长住院时间、危及生命;ADE发生时间0～1d与呼吸困难、延长住院及危及生命的关联性较强;女性与ADE症状为呼吸困难、延长住院的关联性较强，提示女性或速发过敏反应出现不良结局的风险因素较高。结论:不同个体使用奥沙利铂出现过敏反应差异较大，医护人员和药师在日常工作中应重视该药物ADE的监测和上报，探讨其发生规律，并针对性地提出用药监护方案，保障患者用药安全。
Mining of anaphylaxis associated with oxaliplatin on FDA adverse event database and correlation analysis of influencing factors
OBJECTIVE To explore the occurring characteristics and clinical manifestations of allergic reaction-related adverse drug events(ADEs)due to oxaliplatin and provide references for its safe clinical application.METHODS The adverse event reports of anaphylaxis associated with oxaliplatin were collected from the FAERS database by OpenVigil 2.1.After screen-ing,basic profiles,onset of adverse events,symptoms,outcomes and drug combination were recorded.And association of ADE occurrence was explored by Apriori association algorithm rule.RESULTS A total of 2 195 ADE reports related to anaphylaxis associated with oxaliplatin as a primary suspect were collected.Age was distributed predominantly in elderly population aged over 60 years.The countries of occurrence were mostly the United States and other European countries and it was common in patients with colorectal tumors.The most common ADE occurred in 0-1 day,accompanied by dyspnea and hypersensitivity.The out-comes were prolonged hospitalization and life endangering.The occurring time of ADE of 0-1 day had a strong correlation with dyspnea,prolonged hospitalization and life endangering.Females demonstrated a strong correlation with dyspnea and prolonged hospitalization.It hinted that females and immediate ADE anaphylaxis were higher/risk factors for adverse outcomes.CONCLUSION Great differences exist in the anaphylaxis of different individuals on a therapy of oxaliplatin.Physicians and phar-macists should monitor and report ADEs in daily practices,explore the law of occurrence and formulate drug monitoring plans to ensure patient safety.
oxaliplatinFAERSadverse drug eventanaphylaxismedication safety
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