基于FAERS数据库的布罗索尤单抗安全信号挖掘与分析

目的 挖掘并分析布罗索尤单抗相关不良事件（ADE）的信号，为该药的临床安全使用提供参考依据。方法 收集FAERS中的2004年1月1日—2023年6月30日关于布罗索尤单抗的ADE数据，采用比例失衡法中的报告比值比法、比例报告比值比法和贝叶斯置信区间神经网络传播法进行信号挖掘，对报告频数排名前20位、信号强度排名前20位以及各系统器官分类的ADE进行统计分析。结果 共收集布罗索尤单抗相关的ADE报告数4 852份，其中严重ADE报告有996份（占比20.53%）。挖掘到相关信号110个，以肌肉骨骼痛、不宁腿综合征、注射部位反应等较为常见，共涉及8个系统器官，主要集中在肌肉骨骼系统疾病、给药部位各种反应、神经系统疾病和各类检查等。本研究发现说明书中未提示的不良反应/事件共28个，以甲状旁腺功能亢进、骨畸形、骨折为主，并发现1个较罕见警戒信号为不安手综合症。结论 在临床上使用布罗索尤单抗时，除该药说明书中已收录的不良反应外，还需密切关注药品说明书未提及的风险信号（如不安手综合征）以及患者原有疾病的进展情况。

Mining and analysis of burosumab safety signal based on FAERS database

Objective To excavate and analyze the safety signals of burosumab related adverse events (ADE), and to provide reference for the safe clinical use of burosumab. Methods ADE data of burosumab were collected from FAERS from January 1, 2004 to June 30, 2023 . Subsequently signals mining were carried out by using the reported odds ratio method, the reported odds ratio method and Bayes confidence interval neural network propagation method. Statistical analysis was carried out to reveal the top 20 frequent reports, top 20 intensive signals, and ADE classified by various systems and organs. Results A total of 4 852 reports of burosumab related ADE were collected, including 996 reports of serious adverse events (20.53%). A total of 110 signals were found, including musculoskeletal pain, restless leg syndrome, injection site reaction, and other common signals. These signals were mainly from 8 system organs, resulting in musculoskeletal system diseases, various reactions at the administration site, nervous system diseases etc. Current study has also revealed a total of 28 adverse reactions/events which was not disclosed in the instruction of burosumab, including hyperparathyroidism, bone deformity and fracture. In addition, a relatively rare warning signal of burosumab treatment, restless hand syndrome, was discovered and directed the attention in the future clinical use of burosumab. Conclusions The present study has demonstrated not only the adverse reactions of burosumab listed in the medication notice, but also other new risk signals (such as restless hand syndrome) that claim attention for the future use of burosumab in clinic.