基于美国FAERS的玛巴洛沙韦不良事件信号挖掘与分析 点击下载
论文标题： 基于美国FAERS的玛巴洛沙韦不良事件信号挖掘与分析
英文标题：
中文摘要： 目的 挖掘玛巴洛沙韦相关药品不良事件（ADE）信号，为临床安全用药提供参考。方法利用比例报告比（PRR）法对美国FDA不良事件报告系统（FAERS）中2018年1月1日－2022年5月31日上报的有关玛巴洛沙韦的ADE信号进行挖掘。将报告数≥3、PRR≥2且χ2≥4的ADE定义为阳性信号，并采用PRR法对ADE信号进行分析。结果共收集ܨ윓•䜡앍ሃ昃朾괕Ⱚ봸鬀物的ADE报告1424例，涉及ADE信号460个。女性和18岁以下患者的报告数较多；上报数最多的国家是美国；报告中药品的主要适应证为流感。通过PRR法计算及筛选排除后共获得37个ADE阳性信号，其中上报数位于前3位的ADE信号分别为腹泻、呕吐和速发型过敏反应，PRR值位于前3位的ADE信号分别为热性谵妄、缺血性结肠炎和出血性膀胱炎。与玛巴洛沙韦说明书对比，有18个ADE信号尚未被说明书收录，如肝功能异常、血尿、出血性膀胱炎等；涉及5个新的SOC，包括肾脏及泌尿系统疾病、肝胆系统疾病、各类检查、各类神经系统疾病和各种肌肉骨骼及结缔组织疾病。结论临床应用玛巴洛沙韦时，除了关注说明书中记载的不良反应外，还应关注肝功能异常、血尿、出血性膀胱炎等，以保障患者用药安全。
英文摘要： OBJECTIVE To mine adverse drug event （ADE） signals related to baloxavir marboxil， and to provide reference for clinically safe drug use. METHODS The ADE signals related to baloxavir marboxil from January 1， 2018 to May 31， 2022 in the US FDA adverse event reporting system （FAERS） were mined using the proportional reporting odds ratio （PRR） method. ADE with report number≥3， PRR≥2 and χ2≥4 was defined as a positive signal， and PRR method was used to analyze the ADE signal. RESULTS A total of 1 424 ADE reports with baloxavir marboxil as the main suspected drug were collected， involving 460 ADE signals. The femininity and patient under 18 years old were reported more， the country with the highest number of reports was the United States， and the main indication of drug reported was influenza. A total of 37 ADE positive signals were obtained after PRR calculation and screening exclusion， the first three ADE signals in the list of the reported number were diarrhea， vomiting and immediate hypersensitivity， and the first three ADE signals in the list of PRR value were febrile delirium， ischaemic colitis and hemorrhagic cystitis. Compared with the instructions of baloxavir marboxil， 18 ADE signals had not yet been included， such as abnormal liver function， hematuria， hemorrhagic cystitis， etc. Five new SOCs were involved， such as kidney and urinary system diseases， hepatobiliary system diseases， investigations， nervous system disorders and musculoskeletal and connective tissue disorders. CONCLUSIONS When clinical application of baloxavir marboxil， in addition to the adverse drug reactions mentioned in the drug instructions， attention should be paid to abnormal liver function， hematuria， hemorrhagic cystitis， etc， so as to guarantee the safety of drug use.
期刊： 2023年第34卷第07期
作者： 林静；杨文宝；吕灵通
英文作者： LIN Jing，YANG Wenbao，LYU Lingtong
关键字： 玛巴洛沙韦；药品不良事件；药物警戒；比例报告比法；安全用药
KEYWORDS： baloxavir marboxil； adverse drug event； pharmacovigilance； proportional reporting ratio； drug safe use
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