目的 挖掘阿那白滯素（Anakinra）不良事件信號(hào)，為臨床安全合理用藥提供參考。方法 提取FAERS數(shù)據(jù)庫(kù)建庫(kù)至2023年第4季度的不良事件數(shù)據(jù)，利用報(bào)告比值比法（ROR）和貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)法（BCPNN）對(duì)Anakinra可疑風(fēng)險(xiǎn)信號(hào)進(jìn)行挖掘。結(jié)果 共獲得相關(guān)不良事件報(bào)告7 428份，性別以女性（64.9%）為主，上報(bào)國(guó)家以美國(guó)（63.57%）為主。共檢測(cè)到174個(gè)風(fēng)險(xiǎn)信號(hào)，涉及21個(gè)系統(tǒng)和器官分類，主要為全身性疾病及給藥部位各種反應(yīng)（4 362例，40.11%），各類損傷、中毒及操作并發(fā)癥（3 722例，34.22%），發(fā)生頻次較高的首選術(shù)語(yǔ)（PT）包括超說(shuō)明書(shū)使用、注射部位各種反應(yīng)等，新發(fā)現(xiàn)可疑不良反應(yīng)包括肝膽系統(tǒng)相關(guān)不良反應(yīng)、水痘等。剔除消費(fèi)者和未知職業(yè)人員報(bào)告后分析結(jié)論同上。結(jié)論 Anakinra相關(guān)PT信號(hào)涉及系統(tǒng)器官較為廣泛，應(yīng)加強(qiáng)對(duì)Anakinra的臨床規(guī)范化使用管理及超說(shuō)明書(shū)用藥管理，醫(yī)務(wù)人員應(yīng)幫助患者克服注射部位反應(yīng)、加強(qiáng)用藥依從性，在臨床應(yīng)用時(shí)應(yīng)考慮藥物對(duì)實(shí)驗(yàn)室相關(guān)指標(biāo)的影響，在對(duì)待感染性疾病及免疫功能低下患者時(shí)應(yīng)謹(jǐn)慎使用Anakinra，同時(shí)應(yīng)警惕肝膽系統(tǒng)相關(guān)不良反應(yīng)。

Objective The adverse event signal of Anakinra were mined to provide references for safe and rational clinical drug use. Methods Adverse event data from the establishment of FAERS database to the fourth quarter of 2023 were extracted, and the suspicious risk signals of Anakinra were mined by utilizing the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network method (BCPNN). Results A total of 7 428 AE reports were obtained, of which gender predominantly male (64.9%) and country of reporting predominantly US (63.57%). A total of 174 risk signals were detected, involving 21 systems and organ classifications (SOC), mainly General disorders and administration site conditions (4 362 cases, 40.11%), Injury, poisoning and procedural complications (3 722 cases, 34.22%). The more frequent PT included off-label use, injection site reactions, etc. Newly found suspected adverse reactions include hepatobiliary system related adverse reactions, chickenpox, etc. After excluding the reports of consumers and unknown professionals, the analysis results are the same as above. Conclusions Anakinra related PT signals are widely involved in SOC, so standardized clinical use management and off-label use management of Anakinra should be strengthened, medical staff should help patients to overcome injection site reactions and enhance medication compliance, and the influence of drugs on relevant laboratory indicators should be considered in clinical application. Anakinra should be used with caution when treating patients with infectious diseases and immunocompromised patients. At the same time, we should be alert to hepatobiliary related adverse reactions.

R979.9