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作 者:巢艾伦 胡骏 CHAO Ai-lun;HU Jun(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,SHANGHAI 200040,China)
机构地区:[1]上海市药品和医疗器械不良反应监测中心,上海200040
出 处:《中国新药与临床杂志》2024年第2期155-160,共6页Chinese Journal of New Drugs and Clinical Remedies
摘 要:目的基于上市后的药物警戒数据挖掘新型抗病毒药物莫诺拉韦相关不良事件的风险信号,为用药安全提供参考。方法收集2022年1季度至3季度美国食品和药物管理局不良事件报告系统(FAERS)中的莫诺拉韦相关药品不良事件(ADE)报告,采用《国际医学用语词典》(MedDRA)的系统器官分类(SOC)和首选术语(PT)对ADE报告进行归纳、分析,利用报告比值比法及英国药品和保健品管理局的综合标准法挖掘莫诺拉韦安全性风险信号。结果从FAERS数据库中筛选出以莫诺拉韦为怀疑药物的报告共1968份,其中1743份报告含有不良事件,年龄主要分布于≥60岁(58.29%),报告者大部分为医疗专业人员(82.62%);共挖掘出66个PT层面的风险信号,涉及17个SOC。报告数排前6的PT均为莫诺拉韦说明书已提示,分别为腹泻、皮疹、恶心、呕吐、头晕、荨麻疹。皮肤及皮下组织类疾病中的大疱性皮炎、胃肠系统疾病中的出血和各类神经系统疾病中的晕厥、意识丧失等信号,未在莫诺拉韦说明书提示,目前证据尚不能完全排除和莫诺拉韦的关联性。未挖掘到致突变性、影响软骨和骨骼生长等较为关注的风险信号。结论莫诺拉韦安全性较好,挖掘到的排名靠前的风险信号大多为说明书中已知不良反应或肺炎的相关症状,建议临床使用莫诺拉韦时注意大疱性皮炎、胃肠道出血、晕厥、意识丧失等风险。AIM To mine the risk signals of adverse events related to the new antiviral drug molnupiravir based on post-marketing pharmacovigilance data,and to provide reference for drug safety.METHODS The reports of adverse drug events(ADE)related to molnupiravir in the FDA Adverse Event Reporting System(FAERS)from Q1 to Q32022were collected and further analyzed by the system organ classification(SOC)and preferred term(PT)of the International Medical Terminology Dictionary(MedDRA).The reporting odds ratio(ROR)method and the British Medicines and Healthcare Products Regulatory Agency's comprehensive standard method were then used to explore the safety risk signals of molnupiravir.RESULTS A total of 1968 reports with molnupiravir as a suspected drug were screened from the FAERS database,of which 1743 reports contained adverse events.The age of the report subjects was mainly distributed in individuals aged≥60 years old(58.29%),and most of the reporters were medical professionals(82.62%).A total of 66 positive risk signals at the PT level were identified,involving 17 SOCs.The top 6 PTs in the reports were all known in the instruction of molnupiravir,including diarrhea,rash,nausea,vomiting,dizziness,and urticaria.Signals such as bullous dermatitis in skin and subcutaneous tissue diseases,bleeding in gastrointestinal diseases,and syncope and loss of consciousness in various neurological diseases,were not indicated in the instruction of molnupiravir,and their correlation with molnupiravir cannot be completely ruled out by current evidence.No concerned risk signals,such as mutagenicity and affecting cartilage and bone growth were discovered.CONCLUSION Molnupiravir is relatively safe,and most of the top-ranking risk signals identified are known adverse reactions or pneumonia related symptoms described in the instructions.It is recommended to pay attention to risks such as bullous dermatitis,gastrointestinal bleeding,syncope,and loss of consciousness when using molnupiravir clinically.
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