OBJECTIVE To explore adverse event(AE)signals of bevacizumab through the FAERS database and provide a reference for medication monitoring.METHODS The risk signal strength of bevacizumab data from the first quarter of 2004 to the third quarter of 2023 was detected using the reporting odds ratio(ROR),proportional reporting ratio(PRR),multi-item gamma Poisson shrinkage(MGPS),and Bayesian confidence propagation neural network(BCPNN)methods.RESULTS A total of 62 059 AE reports of bevacizumab were retrieved,with slightly more females than males.The highest proportion of reports was found in the age group of 45 to 64 years(24.68％).The United States and Japan reported thehighest numbers of reports.Most AEs occurredwithin the first 30 days after medication treatment.Serious adverse events accounted for 85.99％.A total of 27 System Organ Classes(SOCs)were involved in positive signals,and the top three were systemic diseases,various reactions at the administration site,gastrointestinal disorders,and various examinations.The AEs with high signal intensity mainly included bacterial endophthalmitis,suspected transmission of infectious pathogens through the products,and cartilage necrosis,etc.Among the top 20 AEs with the highest signal intensity,65％were newly identified adverse reactions,such as laryngeal necrosis,tumor perforation,and retinal angiography abnormalities.CONCLUSION Comprehensive risk signal analysis provides a reference for clinical monitoring and risk identification of bevacizumab.
关键词
贝伐珠单抗/药品不良反应信号/FAERS/安全用药
Key words
bevacizumab/adverse drug reaction signals/FAERS/safe medication
维普
万方数据