摘要
目的基于FAERS数据库对新型抗流感病毒药物玛巴洛沙韦(baloxavir marboxil)相关不良事件进行挖掘与分析,探索其不良事件发生的特点及与药物关联的强度,为临床用药提供一定的参考。方法检索并提取FAERS数据库2018年第一季度—2021年第三季度收录以目标药物通用名“baloxavir marboxil”及商品名“Xofluza■”为首要怀疑对象的不良事件报告,利用报告比值比法(ROR)和贝叶斯置信度递进神经网络法(BCPNN)对玛巴洛沙韦的相关报告进行数据挖掘和分析,并利用MedDRA医学用语词典进行汉化及系统归类。结果纳入分析10,608,503份不良事件报告中,以玛巴洛沙韦为首要怀疑药物的AEs报告1428份,发现该药不良反应信号涉及多个系统,具有临床参考意义的高风险信号包括黑便(ROR下限=12.97,IC-2SD=2.96),与神经精神症状相关的意识状态改变(ROR下限=9.66,IC-2SD=2.49)、谵妄(ROR下限=4.92,IC-2SD=1.82)、异常行为(ROR下限=4.31,IC-2SD=1.79),速发过敏反应性休克(ROR下限=12.27,IC-2SD=2.89)、速发过敏反应(ROR下限=9.20,IC-2SD=2.80)以及严重皮肤不良反应多形性红斑(ROR下限=15.90,IC-2SD=2.74);另检测出高风险且说明书中未提及的缺血性结肠炎(ROR下限=23.81,IC-2SD=3.01)及横纹肌溶解(ROR下限=5.65,IC-2SD=2.13)的安全警戒信号。结论基于FAERS不良事件信号检测显示,玛巴洛沙韦在临床使用中应密切关注相关不良反应的发生,尤其是缺血性结肠炎、神经精神症状、过敏反应、严重皮肤不良反应及横纹肌溶解等不良事件,及时采取干预措施,保证用药安全。
Objective To mine and analyze the adverse events related to the new anti-influenza drug,baloxavir marboxil,based on the FAERS database,and to explore the characteristics of adverse events including occurrence,correlation strength between adverse events and drugs,to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2018 to Q3 of 2021,and the adverse event reports with the target drug generic name"baloxavir marboxil"and brand name"Xofluza®"as the primary suspects were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR)and the Bayesian Confidence Progressive Neural Network(BCPNN),and the MedDRA medical terminology dictionary was used for localization and systematic classification.Results Among the 10,608,503 adverse events reports in the analysis,1,428 adverse events were reports with baloxavir marboxil as the primary suspected drug,which involved in multiple systems,and the high-risk signals with clinical significance included:Melena(lower limit of ROR=12.97,IC-2SD=2.96);altered state of consciousness associated with neuropsychiatric symptoms(ROR lower limit=9.66,IC-2SD=2.49);delirium(ROR lower limit=4.92,IC-2SD=1.82);abnormal behavior(ROR Lower limit=4.31,IC-2SD=1.79);anaphylactic shock(ROR lower limit=12.27,IC-2SD=2.89);anaphylaxis(ROR lower limit=9.20,IC-2SD=2.80);and severe skin disorders erythema multiforme(lower limit of ROR=15.90,IC-2SD=2.74).Ischemic colitis(lower limit of ROR=23.81,IC-2SD=3.01)and rhabdomyolysis(ROR lower limit=5.65,IC-2SD=2.13)were also detected as high risk safety signals but not mentioned in the instructions.Conclusion Based on the FAERS adverse event signal detection,baloxavir marboxil must be paid close attention to for occurrence of related adverse reactions in clinical use,especially ischemic colitis,neuropsychiatric symptoms,allergic reactions,severe skin adverse reactions and rhabdomyolysis,etc.Timely intervention measures must be employed to ensure the safety of the drug.
作者
潘辛梅
马攀
Pan Xin-mei;Ma Pan(Department of Pharmacy,the First Affiliated Hospital of Army Medical University,Chongqing 400038)
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2023年第4期466-472,共7页
Chinese Journal of Antibiotics
