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）數(shù)據(jù)庫，挖掘和分析烏司奴單抗不良事件（ADE）信號，為臨床安全用藥提供參考。方法 運用報告比值比法（ROR）聯(lián)合綜合標準法（MHRA）對FAERS數(shù)據(jù)庫2017年第1季度—2021年第4季度中以烏司奴單抗為首要懷疑藥品的ADE報告進行信號挖掘，所得信號利用MedDRA規(guī)范進行漢化和系統(tǒng)歸類并分析。結(jié)果 2017—2021年的藥物ADE中首要懷疑藥物為烏司奴單抗的ADE報告共39 650份，其中女性占多數(shù)（52.67%）；年齡多集中在18～64歲（46.84%）；報告者以醫(yī)務(wù)專業(yè)人員總計上報（55.95%）較高；報告國家前5位分別是美國、加拿大、英國、澳大利亞、巴西，近5年以2020年上報數(shù)量最多，2021年出現(xiàn)下降趨勢。對以烏司奴單抗為首要懷疑藥品的不良反應(yīng)信號進行篩除后，最終獲得烏司奴單抗ADE信號報告數(shù)38 733個，共496個信號。根據(jù)MedDRA的系統(tǒng)器官分類（SOC）分類，對有信號的PT進行SOC分類排序，共發(fā)現(xiàn)有信號的SOC 22個。發(fā)現(xiàn)了說明書未提及的一些新的ADE，如良性、惡性及性質(zhì)不明的腫瘤、各種手術(shù)及醫(yī)療操作、肝膽系統(tǒng)疾病等。結(jié)論 烏司奴單抗常見ADE信號與說明書具有一致性，但累計SOC分類與說明書具有差異性，可為臨床安全用藥提供參考。

Objective Based on the FDA adverse event reporting system (FAERS) database, the ADE signal of ustekinumab was mined and analyzed to provide reference for clinical safe drug use. Methods Reports ratio method (ROR) and comprehensive standard method (MHRA) were used to mine ADE reports of ustekinumab as the primary suspected drug in FAERS database from the first quarter of 2017 to the fourth quarter of 2021. The obtained signals were sinicized and systematically classified and analyzed using MedDRA standards. Results Among ADE reports from 2017 to 2021, a total of 39 650 suspected drugs were ustekinumab, of which women accounted for the majority (52.67%). Most of them were aged from 18 to 64 (46.84%). The total number of medical professionals reported higher (55.95%). The top five reporting countries are the United States, Canada, the United Kingdom, Australia, and Brazil. In the past five years, the number of reported countries is the largest in 2020, and the trend will decline in 2021. After screening the adverse reaction signals of ustekinumab as the primary suspected drug, 38 733 ADE signals were obtained, a total of 496 signals. According to MedDRA's systematic organ classification (SOC) classification, the PT with signal was sorted by SOC classification, and 22 SOC with signal were found. Some new ADE not mentioned in the instructions were found, such as benign, malignant and unknown tumors, various surgical and medical procedures, hepatobiliary diseases, etc. Conclusion Common ADE signals of ustekinumab were consistent with the instructions, but the cumulative SOC classification was different from the instructions, which could provide reference for clinical drug safety.

R986

四川省醫(yī)學(xué)科學(xué)院·四川省人民醫(yī)院科研基金資助項目(2018LY09);成都市金牛區(qū)科研課題(JNKY2021-48)