奥沙利铂相关神经系统不良事件数据挖掘与分析  

Data mining and analysis of oxaliplatin-related adverse events of nervous system

作　　者：范宝霞 孔燕[1] 刘宁[2] 杨平[1] FAN Baoxia;KONG Yan;LIU Ning;YANG Ping(Dept.of Pharmacy,the Fourth People’s Hospital of Jinan,Jinan 250031,China;Dept.of Pharmacy,the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250001,China)

机构地区：[1]济南市第四人民医院药学部,济南250031 [2]山东中医药大学第二附属医院药学部,济南250001

出　　处：《中国药房》2024年第3期348-352,共5页China Pharmacy

基　　金：济南市卫生健康委员会科技计划项目(No.2023-2-74)。

摘　　要：目的 挖掘奥沙利铂相关神经系统不良事件(ADE),为临床安全用药提供参考。方法 收集美国FDA不良事件报告系统(FAERS)2004年1月1日至2022年12月31日上报的奥沙利铂相关神经系统ADE数据。采用报告比值比法和比例报告比值法进行数据挖掘,利用国际医学用语词典(MedDRA)(26.0版)药物ADE术语集中的系统器官分类、高位组语(HLGT)、首选术语(PT)进行分类统计。结果 共检索到各类神经系统疾病的奥沙利铂相关ADE报告7 266例,共挖掘出100个PT。其中,57个PT为奥沙利铂说明书中未记载的ADE信号。这些报告中,男性(46.85%)多于女性(42.98%),年龄以45~<75岁(65.22%)为主,意大利报告数量最多(16.32%);严重ADE以导致住院或住院时间延长为主(38.16%)。报告数排名前5位的PT分别为周围神经病、异常感觉、神经毒性、意识丧失、构音不良;信号强度排名前5位的PT分别为对冷有异样感觉、神经肌肉强直、急性多发性神经病、神经元神经病、轴索和脱髓鞘多发神经病。报告共涉及13个HLGT,以神经类疾病(不另分类)信号数最多(29个)。结论 临床在使用奥沙利铂时,不仅要监护发生率较高的急性、慢性周围神经病变,也要关注患者意识状态、神经病学症状,警惕格林巴利综合征、莱尔米特征、可逆性后部白质脑病综合征、高血氨性脑病等罕见不良反应,以确保患者用药安全。OBJECTIVE To provide reference for clinically safe drug use by mining oxaliplatin-related adverse drug events(ADE)of the nervous system.METHODS Oxaliplatin-related neurologic ADE data reported by the FDA adverse event reporting system(FAERS)between January 1st,2004 and December 31st,2022 were collected.The reporting odds ratio and proportional reporting ratio were used for data mining.The data were classified statistically by using systematic organ classification,high-level group term(HLGT)and preferred term(PT)in the MedDRA(version 26.0).RESULTS A total of 7266 cases of oxaliplatin-related ADE,which were classified as various neurological,were retrieved,and 100 PT were identified.Of these,fifty-seven PT were unspecified adverse reaction signals in the manual.Among these reports,males(46.85%)were more than females(42.98%),the age of patients was 45-<75 years(65.22%),the number of reports was highest in Italy(16.32%),and the severe type was hospitalization or prolonged hospitalization(38.16%).The top 5 PT reports in the list of case number were peripheral neuropathy,paresthesia,neurotoxicity,loss of consciousness and dysarthria.The top 5 PT reports in the list of signal intensities were cold-induced paresthesia,neuromuscular rigidity,acute polyneuropathy,neuronal neuropathy,axonal and demyelinating polyneuropathy.A total of 13 HLGT were involved,with neurological diseases(not classified separately)having the highest number of signals(29).CONCLUSIONS When using oxaliplatin in clinical practice,it is not only necessary to monitor the high incidence of acute and chronic peripheral neuropathy,but also to pay attention to the patient’s consciousness state and neurological symptoms.We should pay attention to the rare types of adverse reactions,such as guillain-barre syndrome,Lhermitte sign,posterior reversible encephalopathy syndrome,and hyperammoniacal encephalopathy,so as to ensure the safety of medication.

关 键 词：奥沙利铂 神经系统毒性 药品不良反应 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]