基于FDA不良事件报告系统探究阿柏西普和雷珠单抗致青光眼风险

Risk mining of glaucoma associated with aflibercept and ranibizumab based on the US FDA Adverse Event Reporting System database

目的评价2种血管内皮生长因子抑制剂(阿柏西普和雷珠单抗)导致青光眼的风险。方法检索美国食品药品管理局(FDA)不良事件报告系统(FAERS)中阿柏西普和雷珠单抗引起青光眼的事件报告,检索时限为2004年1月1日至2020年3月31日。采用报告比数比(ROR)、比例报告比值比(PRR)、贝叶斯可信传播神经网络(BCPNN)和贝叶斯几何均数(EBGM),分析上述2种药物和青光眼不良事件之间的关联。结果根据4种分析方法,2种药物均检测到导致青光眼的信号,阿柏西普致青光眼事件的ROR为5.77(95%Cl:4.81~6.92),PRR为5.74,信息成分(IC)值为2.51,EBGM为5.69(EBGM05为4.89),雷珠单抗致青光眼事件的ROR为10.12(95%Cl:8.87~11.53),PRR为10.21,IC为3.30,EBGM为9.86(EBGM05为8.84),雷珠单抗导致青光眼的信号强度均高于阿柏西普。结论阿柏西普和雷珠单抗均具有可能因眼压升高导致青光眼的风险。临床应用时应谨慎选择患者,并加强监测。

Objective To evaluate the risk of glaucoma associated with two vascular endothelial growth factor inhibitors,aflibercept and ranibizumab.Methods The FDA adverse event reporting system(FAERS)were retrieved to collect the reports of glaucoma associated with aflibercept and ranibizumab between January 1,2004 to March 31,2020.The report score of analogy method(ROR),proportion ratio ratio method(PRR),Bayesian credible propagation neural network(BCPNN)and Bayesian geometric mean(EBGM)were used to identify the link between the drugs and adverse events.Results According to the four analysis methods,the ROR value of the glaucomatous event caused by aflibercept was 5.77(95%Cl:4.81-6.92),PRR value was 5.74,IC value was 2.51,EBGM value was 5.69(EBGM05:4.89),and ROR value of the glaucomatous event caused by ranibizumab was 10.12(95%Cl:8.87-11.53),PRR value was 10.21,IC value was 3.30,and EBGM value was9.86(EBGM05:8.84),glaucomatous signal was detected for both VEGF receptor antagonists,and the signal intensities of ranibizumab by the four methods were all stronger than those of aflibercept.Conclusions Both aflibercept and ranibizumab may increase the risk of glaucoma due to elevated intraocular pressure.Cautions should be taken when choosing the therapy subjects and the patients should be monitored for adverse reactions during the treatment.