阿替利珠单抗的不良事件风险信号挖掘  

Excavation for adverse events signals of atezolizumab

作　　者：狄潘潘 胡云飞 孟祥松 钱会[3] 贾淑云[1] DI Panpan;HU Yunfei;MENG Xiangsong;QIAN Hui;JIA Shuyun(Pharmacy Intravenous Admixture Services,Bozhou Municipal People’s Hospital,Anhui Bozhou 236800,China;School of Traditional Chinese Medicine,Bozhou University,Anhui Bozhou 236800,China;Dept.of Respiratory and Critical Care Medicine,Bozhou Municipal People’s Hospital,Anhui Bozhou 236800,China)

机构地区：[1]亳州市人民医院静配中心,安徽亳州236800 [2]亳州学院中药学院,安徽亳州236800 [3]亳州市人民医院呼吸与危重症医学科,安徽亳州236800

出　　处：《中国药房》2022年第24期3025-3028,3033,共5页China Pharmacy

基　　金：安徽省教育厅高校自然科学研究项目(No.KJ2021A1146);安徽省高校学科(专业)拔尖人才学术资助项目(No.gxbjZD2020095)。

摘　　要：目的挖掘阿替利珠单抗上市后的药品不良事件(ADEs)风险信号,为其临床合理使用提供参考。方法收集FAERS数据库中阿替利珠单抗从上市(2016年5月18日)至2022年3月31日的ADEs报告。采用报告比值比(ROR)法和综合标准法(以下简称“MHRA法”)对阿替利珠单抗的ADEs风险信号进行挖掘,利用《国际医学用语词典》(23.0版)药物不良反应术语集中的首选术语(PT)和系统器官(SOC)进行描述和分类。结果共收集到16051份以阿替利珠单抗为首要怀疑药物的ADEs报告,挖掘出401个PT,涉及17个SOC。16051份报告中,以男性患者居多(51.64%),年龄主要分布在19~64岁和≥65岁。按报告数排序,ADEs主要表现为发热、疾病进展、间质性肺病、贫血症和肺炎等,累及的SOC包括肾脏及泌尿系统疾病,良性、恶性及性质不明的肿瘤(包括囊肿和息肉)和内分泌系统疾病等;按信号强度排序,发现说明书未收录的ADEs包括黄斑增厚、副肿瘤神经综合征、反应性穿孔性胶原病、副肿瘤性皮肌炎、抗红细胞抗体阳性和肺结节病。结论临床在使用阿替利珠单抗时,除关注患者可能出现说明书中已收录的ADEs外,还应重点关注眼部、神经及皮肤系统方面的ADEs,以保障患者用药安全。OBJECTIVE To excavate the risk signals of adverse drug events(ADEs)of atezolizumab after marketing,so as to provide a reference for rational use of atezolizumab.METHODS Using the FAERS database,the ADEs of atezolizumab were collected from marketing on May 18th 2016 to Mar.31st 2022.The ADEs risk signals were mined by reported odds ratio(ROR)and medicines and Healthcare Products Regulatory Agency method(MHRA),and then described and classified by preferred term(PT)and system organ classification(SOC)in the adverse drug reaction glossary of Medical Dictionary for Regulatory Activities(MedDRA)(23.0 edition).RESULTS A total of 16051 ADEs reports with atezolizumab as the primary suspected drug were collected,and 401 PT were mined,involving 17 SOC.In 16051 ADEs reports,the majority of patients were male(51.64%),with main age distribution of 19 to 64 years old and more than 65 years old.According to the number of reports,ADEs were mainly focusing on pyrexia,disease progression,interstitial lung disease,anaemia,pneumonia,etc.The involved SOC includes kidney and urinary system diseases,benign,malignant and unknown tumors(including cysts and polyps),endocrine system diseases,etc.According to the signal intensity,the new ADEs not specified in the drug instructions were macular thickening,paraneoplastic neurological syndrome,reactive perforating collagenosis,paraneoplastic dermatomyositis,anti-erythrocyte antibody positive and liver sarcoidosis.CONCLUSIONS In addition to the ADEs mentioned in the drug instructions,when using atezolizumab in clinic,attention should also be closely paid to ADEs of eyes,nervous and skin system,so as to ensure the safety of drug use in patients.

关 键 词：阿替利珠单抗 药品不良事件 警戒信号 数据挖掘 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]