摘要
目的 促进贝伐珠单抗的临床安全使用。方法 通过美国食品和药物管理局不良事件报告系统(FAERS)提取2014年1月1日至2023年5月1日以贝伐珠单抗为首要怀疑药物的药品不良事件(ADE)报告,借助OpenVigil 2.1在线工具进行数据挖掘;采用报告比值比(ROR)法和贝叶斯置信区间递进神经网络(BCPNN)法联合检验ADE信号,利用《监管活动医学词典》(MedDRA)25.1中的首选语(PT)和系统器官分类(SOC)对ADE信号进行归类与分析。结果 共获得以贝伐珠单抗为首要怀疑药物的ADE报告60 675份,涉及患者60 675例,上报地区主要为北美洲(48.78%)和亚洲(29.00%);严重ADE报告中,以死亡报告数最多(14 358例,23.66%)。605个PT信号涉及ADE报告20 127份(患者20 127例),可归入21个SOC,信号数排前3的SOC分别为胃肠系统疾病(89个),良性、恶性及性质不明的肿瘤(包括囊状和息肉状肿瘤,68个)及眼器官疾病(66个);ADE例数排前3的SOC分别为全身性疾病及给药部位各种反应(3 059例)、血液及淋巴系统疾病(2 813例)和血管与淋巴管类疾病(2 235例)。ADE报告例数排前5的PT分别为疾病进展(1 279例)、高血压(1 072例)、贫血(585例)、骨髓抑制(583例)和蛋白尿(569例)。结论 临床医师在用药期间除关注贝伐珠单抗的常见ADE外,应重点关注其导致的高血压、蛋白尿、骨髓抑制、出血、胃肠穿孔、间质性肺病等严重ADE。
Objective To promote the clinical safe use of bevacizumab.Methods The adverse drug event(ADE)reports with bevacizumab as the primary suspected drug from January 1,2014 to May 1,2023 were obtained by the FDA Adverse Event Reporting System(FAERS).The data mining was performed by the OpenVigil 2.1 online tool.The ADE signals were tested by the reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)methods,and they were classified and analyzed based on the preferred term(PT)and system organ classification(SOC)in the Medical Dictionary for Regulatory Activities(MedDRA)25.1.Results A total of 60675 ADE reports with bevacizumab as the primary suspected drug were obtained,involving 60675 patients,mainly from North America(48.78%)and Asia(29.00%);in serious ADE reports,the death reports were the most(14358 cases,23.66%).A total of 605 PT signals were involved in 20127 ADE reports(20127 patients),which could be classified into 21 SOCs;the top three SOCs with more signals were gastrointestinal diseases(89 signals),benign,malignant and unknown tumors(including cystic and polypoid tumors,68 signals),and eye organ diseases(66 signals);the top three SOCs with more cases of ADEs were systemic diseases and various reactions at the administration site(3059 cases),blood and lymphatic system diseases(2813 cases),vascular and lymphatic vessel diseases(2235 cases).The top five PTs with more cases of ADE reports were disease progression(1279 cases),hypertension(1072 cases),anemia(585 cases),bone marrow suppression(583 cases),proteinuria(569 cases).Conclusion During the medication,clinical physicians should not only pay attention to the common ADEs induced by bevacizumab,but also focus on the serious ADEs such as hypertension,proteinuria,bone marrow suppression,bleeding,gastrointestinal perforation,and interstitial pneumonia.
作者
庞培杰
殷鑫
刘天宇
贾映东
PANG Peijie;YIN Xin;LIU Tianyu;JIA Yingdong(North Sichuan Medical College,Nanchong,Sichuan,China 637000;Suining Central Hospital,Suining,Sichuan,China 629000)
出处
《中国药业》
CAS
2024年第14期109-113,共5页
China Pharmaceuticals
基金
四川省医学科研青年创新课题项目[Q18046]。
