目的 通過對美國食品藥品管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）挖掘阿普米司特的風(fēng)險(xiǎn)信號，為臨床使用的安全性提供參考依據(jù)。方法 采用報(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)（BCPNN）對美國FAERS數(shù)據(jù)庫中2014年第1季度—2023年第3季度阿普米司特相關(guān)不良事件（ADE）進(jìn)行數(shù)據(jù)挖掘和分析。結(jié)果 共檢索出阿普米司特相關(guān)ADE報(bào)告70 075份，以女性病例（61.4%）為主，年齡主要集中18～65歲（34.6%）；上報(bào)國家主要以美國（96.5%）為主；經(jīng)篩選出陽性信號70個(gè)，涉及12個(gè)系統(tǒng)器官（SOC）；挖掘出的信號提示阿普米司特相關(guān)ADE報(bào)告主要集中在胃腸系統(tǒng)疾病、各類神經(jīng)系統(tǒng)疾病、精神病類、感染及侵染類疾病，頻數(shù)發(fā)生較多的PT主要是腹瀉、惡心、頭痛、腹部不適等；信號較強(qiáng)的PT主要是緊張性頭痛、腹瀉、排便頻率增加、糞便松軟、腹部不適等；新的風(fēng)險(xiǎn)信號有38個(gè)，包括潛伏性結(jié)核、病毒性胃腸炎、耳部感染、上呼吸道充血、痛風(fēng)等。結(jié)論 使用阿普米司特應(yīng)在治療期間，重點(diǎn)關(guān)注患者的胃腸道反應(yīng)，同時(shí)評估患者的精神狀況，監(jiān)測有感染、腎臟不全功能患者的使用，以保證治療的安全性。

Objective The risk signals of apremilast were extracted from the Adverse Event Reporting System (FAERS) of the US Food and Drug Administration (FDA) to provide reference for the safety of clinical use. Methods Reporting Odds ratio method (ROR) and Bayesian confidence interval Progressive neural network (BCPNN) were used to conduct data mining and analysis of apremilast related adverse events (ADE) in the FAERS database from the first quarter of 2014 to the third quarter of 2023. Results A total of 70 075 ADE reports related to the apremilast were retrieved, the majority of patients were female (61.4%) and were concentrated between the ages of 18 — 65 (34.6%), with the main reporting countries being the United States (96.5%). 70 Positive signals were screened out, involving 12 systems and organs (SOC), mainly including gastrointestinal system diseases, nervous system disorders, psychiatric disorders, infections and infestations. The main PT that occur more frequently were diarrhea, nausea, headache, and abdominal discomfort, etc. The PT with high signal strength ranking included tension headaches, diarrhea, frequent bowel movements, faeces soft, abdominal discomfort and so on. 38 New risk signals were found, including latent tuberculosis, gastroenteritis viral, ear infection, upper respiratory tract congestion and gout, etc. Conclusion During the use of apremilast, it is necessary to focus on the patient's gastrointestinal response and assess the patient’s psychiatric status, as well as paying close attention to the patients with infection and renal insufficiency function, so as to guarantee the safety of treatment.

R979.5