目的 基于美國(guó)食品藥品管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）收集曲拉西利的不良事件報(bào)告，挖掘新的嚴(yán)重的不良事件，為臨床安全用藥提供參考。方法 獲取FAERS中2004年第1季度—2023年第4季度曲拉西利相關(guān)的不良事件報(bào)告，采取報(bào)告比值比法（ROR）、比例報(bào)告比值比（PRR）、貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)（BCPNN）法與多項(xiàng)式伽馬泊松分布縮減法（MGPS）聯(lián)用對(duì)不良事件報(bào)告進(jìn)行數(shù)據(jù)挖掘與分析。結(jié)果 共獲得與曲拉西利相關(guān)的不良事件報(bào)告457例次，在已知性別、年齡或地區(qū)的不良事件報(bào)告中，男女比例相近，45～65歲不良事件報(bào)告數(shù)占比最大。曲拉西利的不良事件報(bào)告涉及19個(gè)系統(tǒng)器官分類（SOC），包括全身性疾病及給藥部位各種反應(yīng)、各類檢查、精神類疾病等，陽(yáng)性信號(hào)主要包括超說明書使用、骨髓抑制呼吸困難、體力狀態(tài)下降等。結(jié)論 曲拉西利不良事件信號(hào)有效與說明書基本一致，同時(shí)還發(fā)現(xiàn)了一些新的潛在曲拉西利信號(hào)，如焦慮、心境抑郁、神經(jīng)緊張不安等，值得臨床關(guān)注。

Objective To collect adverse drug event reports of trilaciclib based on FAERS database, explore new and serious adverse events, and provide reference for clinical safe drug use. Method Obtaining adverse event reports related to trilaciclib in FAERS from Q1 2004 to Q4 2023, and use a combination of ROR, PRR, BCPNN, and MGPS to mine and analyze adverse event reports. Results A total of 457 adverse drug event reports related to trilaciclib were obtained. Among trilaciclib reports of known gender, age, or region, the male to female ratio was similar, with the highest proportion of ADE reports occurring between the ages of 45 and 65. Adverse drug event report of trilaciclib involves 19 SOC, including systemic diseases and various reactions at the site of administration, various examinations, psychiatric disorders, etc. Positive signals mainly include use beyond the instructions and bone marrow suppression difficulty breathing, decreased physical condition, etc. Conclusion The adverse event signals of trilaciclib are effectively consistent with the instructions, and some new potential signals have been discovered, such as anxiety, mood depression, and nervousness, which are worthy of clinical attention.

R979.1

蕪湖市衛(wèi)生健康委員會(huì)華佗計(jì)劃高層次人才分層培養(yǎng)項(xiàng)目（蕪衛(wèi)組[2023]111號(hào)）