目的 基于美國食品藥品監(jiān)督管理局（FDA）不良事件報告系統(tǒng)（FAERS）中的不良事件報告挖掘泊馬度胺相關的不良事件信號，為臨床安全合理用藥提供參考。方法 收集FAERS數(shù)據(jù)庫中泊馬度胺2013年2月8日—2024年3月20日的數(shù)據(jù)，采用報告比值比法（ROR）和貝葉斯可信傳播神經網絡法（BCPNN）法進行不良事件信號挖掘。結果 最終納入14 618份有效泊馬度胺不良事件報告，得到152個不良事件信號，共累及17個器官系統(tǒng)分類（SOC）。其中男性構成比（50.43%）高于女性（45.03%）；年齡主要分布在60歲以上（56.37%）的人群；累及的SOC主要包括各類檢查，呼吸系統(tǒng)、胸及縱隔疾病，血液及淋巴系統(tǒng)疾病，感染及侵染類疾病等；報告數(shù)量較多的不良事件信號包括感染性肺炎、中性粒細胞減少癥、白細胞計數(shù)降低、周圍神經病等。泊馬度胺說明書中未記載的新的可疑不良反應包括人絨毛膜促性腺激素增加、牙病、心房破裂、克隆性造血、進行性多灶性腦白質病、腦深部核團高敏等。結論 基于FAERS數(shù)據(jù)庫挖掘到的泊馬度胺相關不良反應，與藥品說明書中提到的基本一致，同時也存在部分新發(fā)現(xiàn)的可疑不良反應，在臨床用藥時應關注。

Objective To mine the adverse event signals related to pomalidomide based on the adverse reaction reports in the FAERS database, so as to provide references for clinical safe and rational drug use. Methods The data of pomalidomide in FAERS database from February 8, 2013 to March 20, 2024 were collected, and adverse event signal mining was carried out using the method of reported odds ratio (ROR) and Bayesian credible propagation neural network (BCPNN). Results 14 618 effective adverse event reports of pomalidomide were finally included, and 152 adverse event signals were obtained, involving a total of 17 organ system classifications (SOC). The proportion of men (50.43%) was higher than that of women (45.03%). The ages were mainly distributed in people older than 60 years (56.37%), the SOC involved mainly includes various examinations, respiratory system, chest and mediastinal diseases, blood and lymphatic system diseases, infection and infection diseases, etc. A large number of adverse event signals reported include infectious pneumonia, neutropenia, decreased white blood cell count, peripheral neuropathy, etc. New suspicious adverse reactions not recorded in the instructions of pomalidomide include human chorionic gonadotropin increased, tooth disorder, atrial rupture, clonal hematopoiesis, progressive multifocal leukoencephalopathy, and hyperintensity in brain deep nuclei, etc. Conclusion The adverse reactions related to pomalidomide discovered based on the FAERS database are basically consistent with those mentioned in the drug instructions. At the same time, there are also some newly discovered suspicious adverse reactions, which should be paid attention to in clinical medication.

R979.1