地舒单抗的肌肉骨骼相关毒性:基于FAERS对地舒单抗不良反应信号的挖掘与分析  

Musculoskeletal-related Toxicity of Denosumab:Data Mining and Safety Analysis of Denosumab Based on FAERS Database

作　　者：胥甜甜[1] 万青[1] 焦守峰 毕群群 XU Tiantian;WAN Qing;JIAO Shoufeng;BI Qunqun(The First Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330006,China)

机构地区：[1]南昌大学第一附属医院,江西南昌330006

出　　处：《药品评价》2023年第9期1095-1100,共6页Drug Evaluation

基　　金：江西省卫生健康委科技计划(SKJP220228210)。

摘　　要：目的 评价地舒单抗的安全警戒信号,为临床安全用药提供参考。方法 调取美国FDA不良事件报告系统(FAERS)中地舒单抗在美国上市后连续46个季度的数据,采用报告比值比法(ROR)和比例报告比值法(PRR)进行信号挖掘,以分析其不良反应的发生情况。结果 得到的602个不良反应信号表明,肌肉骨骼疾病是发生频率和强度最高的不良反应类型,对SOC项下“肌肉骨骼及结缔组织疾病”进行了分析,结果显示主要的不良反应包括颌骨骨坏死、关节痛、肢体疼痛、背痛、肌痛、骨痛等,这些都有在说明书中记录,同时还发现了一些未被记录在说明书中的不良反应,例如颌骨外生性骨疣、颌部瘘管、动脉瘤样骨囊肿,颌骨疼痛、肌痉挛等。结论 临床上常应用地舒单抗治疗骨质疏松和骨肿瘤等骨骼相关疾病,但是该药的骨骼相关不良反应发生的强度最高,因此在临床使用过程中,需要特别关注与肌肉骨骼疾病相关的不良反应,并区分原发疾病及不良反应。Objective Denosumab was first approved by the European Drug Administration in May 2010,officially entered China in May 2019.It has been recommended by many authoritative guidelines and monographs for the treatment of osteoporosis,bone giant cell tumor,bone metastasis and other diseases of solid tumors.To explore the safety warning signals of denosumab after its marketing in the FDA Adverse Event Reporting System(FAERS)to provide reference for clinical rational drug use.Methods The data of denosumab in FAERS were collected for 46 consecutive quarters after its marketing in the United States.The reported odds ratio method(ROR)and proportional report ratio method(PRR)were utilized to detect and analysis the adverse reactions signals of denosumab.Results 602 adverse reaction signals were obtained.The highest frequency and intensity of adverse effects were concentrated in musculoskeletal and connective tissue disorders.Analysis of the"musculoskeletal and connective tissue disorders"under the SOC,the main adverse effects were osteonecrosis of the jaw,arthralgia,limb pain,back pain,myalgia,and bone pain,but also found some adverse reactions that were not included in the instructions,Such as jaw exogenous bone warts,jaw fistula,aneurysm-like bone cyst,jaw pain,muscle spasm et al.Conclusion Clinical use of denosumab is mostly used for osteoporosis,bone tumours and other bone-related diseases.Through analysis,the bone-related adverse effects have the highest intensity,it suggests that we should focus on musculoskeletal diseases,pay attention to distinguish between primary diseases and adverse reactions,preventive measures and therapeutic measures are adopted to reduce the harm caused by adverse reactions.

关 键 词：地舒单抗 药物相关性副作用和不良反应 信号挖掘 比例失衡法 美国FDA不良事件报告系统 

分 类 号：R969[医药卫生—药理学]