基于FDA不良事件报告系统数据库的咪达唑仑口服制剂不良反应信号分析  

Signal mining and analysis of adverse reactions of oral midazolam based on FDA adverse event reporting system

作　　者：李佳菀 蔡文君 周双[1] 周颖[1] LI Jiayu;CAI Wenjun;ZHOU Shuang;ZHOU Ying(Department of Pharmacy,Peking University First Hospital,Beijing 100034,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]北京大学第一医院药剂科,北京100034 [2]中国药科大学基础医学与临床药学学院,南京211198

出　　处：《临床药物治疗杂志》2025年第3期62-67,共6页Clinical Medication Journal

摘　　要：目的基于FDA不良事件报告系统(FAERS)数据库筛选咪达唑仑口服制剂不良反应信号,为临床用药安全提供参考。方法采用报告比值比、综合标准法、贝叶斯可信传播神经网络法和多项伽马泊松分布缩减法4种方法对FAERS数据库中2004年1月至2024年3月的咪达唑仑口服制剂相关不良反应信号进行检测。结果共收集到434份咪达唑仑口服制剂发生不良反应的报告,检测到阳性信号35个,涉及13个系统器官分类,主要分布在各类神经系统疾病(26.21%),精神病类(22.34%)和心脏器官疾病(15.12%)等。阳性信号发生频率前5位的分别为自杀既遂、意识丧失、故意过量使用药物、昏迷和射血分数降低;以信息成分(IC)值排序,自杀既遂、射血分数降低、呼吸抑制、反射消失和呼吸停止与咪达唑仑口服制剂的联系较强。结论自杀既遂、意识丧失、射血分数降低、呼吸抑制等不良反应的发生与咪达唑仑口服制剂联系紧密,建议咪达唑仑口服制剂时密切监护患者心肺功能和意识状态,警惕患者心理状态,预防自杀等不良反应发生,临床中应多学科协作,开展有针对性的药学监护,对不良反应及时干预,保障患者的用药安全性。Objective To conduct signal mining and analyze the adverse events related to oral midazolam based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,in order to provide a reference for clinical medication safety.Methods Reporting odds ratio,Medicines and Health-care products Regulatory Agency method,Bayesian Confidence Propagation Neural Network method and multi-item gamma Possion shrinker method were used to detect the signals of oral midazolam-associated adverse events in the FAERS database from the 1st quarter of 2004 to the 1st quarter of 2024.Results A total of 434 reports of adverse events related to oral midazolam were collected,and 35 positive signals were detected,involving 13 organ system classifications,mainly in nervous system disorders(26.21%),psychiatric disorders(22.34%),and cardiac disorders(15.12%).The top five positive signals occurring with the highest frequency were completed suicide,intentional overdose,loss of consciousness,coma,decreased ejection fraction decreased,respectively;Sorted by value of information components(IC),completed suicide,ejection fraction decreased,respiratory depression,areflexia and respiratory arrest were strongly associated with oral midazolam.Conclusion The occurrence of adverse events such as decreased ejection fraction,loss of consciousness and respiratory depression were strongly associated with oral midazolam.It is recommended that patients'cardiorespiratory function and state of consciousness should be closely monitored,and their psychological state should be paid close attention to prevent the occurrence of suicide and other adverse events when taking oral midazolam.The multidisciplinary team should work collaboratively to develop targeted pharmacologic surveillance,take timely intervention to restrict the development of adverse events,and ensure the medication safety of the patient.

关 键 词：FDA不良事件报告系统 咪达唑仑口服制剂 比值失衡测量法 贝叶斯法 

分 类 号：R969.3[医药卫生—药理学] R971.2[医药卫生—药学]