地舒单抗不良反应信号挖掘与分析  

Excavation and analysis of ADR signals of denosumab

作　　者：吴玉婷[1] 焦甲勋 朱小丽 李娜[1] WU Yuting;JIAO Jiaxun;ZHU Xiaoli;LI Na(Department of Pharmacy,Taizhou People's Hospital,Taizhou,Jiangsu 225300,China;a Department of Osteooncology,The People's Hospital of Hengshui,Hengshui,Hebei 053000,China;Department of Pharmacy,The People's Hospital of Hengshui,Hengshui,Hebei 053000,China)

机构地区：[1]泰州市人民医院药学部,江苏泰州225300 [2]衡水市人民医院骨肿瘤科,河北衡水053000 [3]衡水市人民医院药学部,河北衡水053000

出　　处：《安徽医药》2023年第9期1899-1903,共5页Anhui Medical and Pharmaceutical Journal

基　　金：河北省2022年度医学科学研究课题计划(20220467)。

摘　　要：目的通过对地舒单抗相关药品不良反应(ADR)进行挖掘与分析,为临床安全合理用药提供依据。方法采用比例失衡分析法中的报告比值比法(ROR)和比例报告比值比法(PRR)对美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中地舒单抗2010年第3季度至2021年第3季度中发生的ADR进行挖掘及分析。结果提取到28823例以地舒单抗为首要怀疑药物的ADR报告,共检测出有效信号256例,涉及19个器官系统分类。主要涉及肌肉骨骼及结缔组织疾病,胃肠系统疾病,各类检查和感染及侵染类疾病等。在信号强度排序前50的ADR中不仅包括说明书中已知的口腔相关ADR、颌骨坏死、各种类型骨折、外耳道骨坏死、钙离子相关ADR等。还包括说明书中未提及的ADR 9种,分别是颌骨外生骨疣,高钙性肾病,免疫介导的肾上腺功能不全,脊柱畸形,纵隔纤维化,甲状腺钙化,椎间盘环形撕裂,下颌骨肿块,关节杂音。结论地舒单抗使用过程中,医务人员不仅要重点关注肌肉骨骼及结缔组织疾病、胃肠系统疾病、各类检查和感染及侵染类疾病,对于信号挖掘发现的新的ADR也应该提高警惕,积极预防和治疗,以减少ADR对病人的危害。Objective To provide reference for clinical safety and rational drug use through mining and analyzing the adverse drug reaction(ADR)signals of denosumab.Methods Disproportionality analysis with reporting odds ratio(ROR)and proportional reporting ratio(PRR)was used to detect ADR signals of denosumab in the FDA adverse event reporting system(FAERS)from the third quarter of 2010 to the third quarter of 2021.Results A total of 28823 adverse event reports with denosumab as the primary suspected drug were extracted.Totally 256 signals were detected,involving 19 organ systems,which mainly reported musculoskeletal and connective tissue disorders,gastrointestinal disorders,and infectious diseases.The top 50 ADRs in signal strength ranking included not only diseases reported in the specifications,oral related ADR,osteonecrosis of jaw,various types of fracture,osteonecrosis of external auditory canal,and calcium ion related ADR,but also diseases not mentioned in the specifications,including exostosis of jaw,hypercalcaemic nephropathy,immune-mediated adrenal insufficiency,spinal deformity,mediastinal fibrosis,thyroid calcification,intervertebral disc annular tear,mandibular mass,and joint noise.Conclusion During the use of denosumab,medical staff should not only focus on musculoskeletal and connective tissue disorders,gastrointestinal disorders,and various infectious diseases,but also be alert to new ADRs discovered by signal mining,to actively prevent and treat them to reduce the harm caused by ADRs to patients.

关 键 词：抗体 单克隆 药物相关性副作用和不良反应 地舒单抗 不良反应 信号挖掘 

分 类 号：R97[医药卫生—药品]