基于FAERS数据库的贝伐珠单抗不良事件信号挖掘与分析

Mining and Analysis of Bevacizumab Adverse Event Signals Based on FAERS Database

目的通过FAERS数据库,挖掘贝伐珠单抗不良事件(AE)信号,为用药监护提供参考。方法利用报告比值法(ROR)、比例报告比值比法(PRR)、多项式伽马泊松分布缩减法(MGPS)和贝叶斯可信区间递进神经网络法(BCPNN)检测2004年第1季度至2023年第3季度贝伐珠单抗的数据风险信号强度。结果检索到贝伐珠单抗AE报告共62059份,女性稍多于男性,45~64岁年龄段人数占比最高(24.68%);美国和日本上报数量较多;大多数AE发生在用药治疗后的前30 d;严重AE占比85.99%;阳性信号共涉及27个SOC,前3位为全身性疾病及给药部位各种反应、胃肠系统疾病和各类检查;信号强度较高的AE主要有细菌性眼内炎、感染性病原体疑似通过产品传播、软骨坏死等。信号强度前20位AE中65%为新的不良反应,如喉坏死、肿瘤穿孔、视网膜血管造影异常等。结论全面的风险信号分析为临床监测和贝伐珠单抗风险识别提供参考。

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 62059 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.