FAN Baoxia,KONG Yan,LIU Ning,et al.Data mining and analysis of oxaliplatin-related adverse events of nervous system[J].ZHONGGUO YAOFANG,2024,35(03):348-352.
FAN Baoxia,KONG Yan,LIU Ning,et al.Data mining and analysis of oxaliplatin-related adverse events of nervous system[J].ZHONGGUO YAOFANG,2024,35(03):348-352. DOI: 10.6039/j.issn.1001-0408.2024.03.15.
Data mining and analysis of oxaliplatin-related adverse events of nervous system
To provide reference for clinically safe drug use by mining oxaliplatin-related adverse drug events (ADE) of the nervous system.
METHODS
2
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
2
A total of 7 266 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
2
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
Keywords
neurotoxicityadverse drug reactionssignal mining
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