目的 挖掘并分析布羅索尤單抗相關(guān)不良事件（ADE）的信號(hào)，為該藥的臨床安全使用提供參考依據(jù)。方法 收集FAERS中的2004年1月1日—2023年6月30日關(guān)于布羅索尤單抗的ADE數(shù)據(jù)，采用比例失衡法中的報(bào)告比值比法、比例報(bào)告比值比法和貝葉斯置信區(qū)間神經(jīng)網(wǎng)絡(luò)傳播法進(jìn)行信號(hào)挖掘，對(duì)報(bào)告頻數(shù)排名前20位、信號(hào)強(qiáng)度排名前20位以及各系統(tǒng)器官分類的ADE進(jìn)行統(tǒng)計(jì)分析。結(jié)果 共收集布羅索尤單抗相關(guān)的ADE報(bào)告數(shù)4 852份，其中嚴(yán)重ADE報(bào)告有996份（占比20.53%）。挖掘到相關(guān)信號(hào)110個(gè)，以肌肉骨骼痛、不寧腿綜合征、注射部位反應(yīng)等較為常見，共涉及8個(gè)系統(tǒng)器官，主要集中在肌肉骨骼系統(tǒng)疾病、給藥部位各種反應(yīng)、神經(jīng)系統(tǒng)疾病和各類檢查等。本研究發(fā)現(xiàn)說(shuō)明書中未提示的不良反應(yīng)/事件共28個(gè)，以甲狀旁腺功能亢進(jìn)、骨畸形、骨折為主，并發(fā)現(xiàn)1個(gè)較罕見警戒信號(hào)為不安手綜合癥。結(jié)論 在臨床上使用布羅索尤單抗時(shí)，除該藥說(shuō)明書中已收錄的不良反應(yīng)外，還需密切關(guān)注藥品說(shuō)明書未提及的風(fēng)險(xiǎn)信號(hào)（如不安手綜合征）以及患者原有疾病的進(jìn)展情況。

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.

R977

國(guó)家自然科學(xué)基金青年項(xiàng)目（82000842）；廣東省基礎(chǔ)與應(yīng)用基礎(chǔ)研究基金項(xiàng)目（2021B1515140054）；東莞市社會(huì)發(fā)展科技面上項(xiàng)目（20211800903072）；廣東省醫(yī)院藥師青年托舉研究基金（晴粵藥學(xué)基金）（2023QNTJ39）