目的 基于美國(guó)食品藥品監(jiān)督管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）挖掘6種非典型抗精神病藥物氯氮平、奧氮平、阿立哌唑、喹硫平、利培酮、齊拉西酮血液系統(tǒng)不良事件（ADE）信號(hào)，為臨床安全使用非典型抗精神病藥物提供參考。方法 下載2017年第1季度—2021年第3季度共19個(gè)季度的FAERS數(shù)據(jù)，采用比值失衡法中的報(bào)告比值比（ROR）法和綜合標(biāo)準(zhǔn)法（MHRA）檢測(cè)數(shù)據(jù)庫(kù)中非典型抗精神病藥物的ADE信號(hào)，統(tǒng)計(jì)并分析血液系統(tǒng)ADE信號(hào)的相關(guān)信息。結(jié)果 從FAERS數(shù)據(jù)庫(kù)得到以氯氮平、奧氮平、阿立哌唑、利培酮、喹硫平、齊拉西酮6種非典型抗精神病藥物為首要懷疑藥物的ADE共389431例次，涉及報(bào)告病例116706例。血液系統(tǒng)ADE報(bào)告共計(jì)47144例次，涉及報(bào)告病例9658例。氯氮平產(chǎn)生血液系統(tǒng)信號(hào)22個(gè)，涉及報(bào)告病例6808例；奧氮平產(chǎn)生血液系統(tǒng)信號(hào)19個(gè)，涉及報(bào)告病例736例；喹硫平產(chǎn)生血液系統(tǒng)信號(hào)18個(gè)，涉及報(bào)告病例560例；阿立哌唑產(chǎn)生血液系統(tǒng)信號(hào)8個(gè)，涉及報(bào)告病例60例；利培酮產(chǎn)生血液系統(tǒng)信號(hào)3個(gè)，涉及報(bào)告病例16例；齊拉西酮產(chǎn)生血液系統(tǒng)信號(hào)1個(gè)，涉及報(bào)告病例5例。結(jié)論 基于真實(shí)世界的非典型抗精神病藥物血液系統(tǒng)ADE信號(hào)挖掘有助于開(kāi)展安全性評(píng)價(jià)，為臨床安全應(yīng)用提供參考。

Objective To explore the hematological adverse drug event (ADE) reaction signals of atypical antipsychotics based on the US FDA adverse event reporting system (FAERS), and to provide reference for the safe use of atypical antipsychotics in clinical practice. Methods FAERS data for a total of 19 quarters from Q1 2017 to Q3 2021 were downloaded to detect the ADE signals of six atypical antipsychotic drugs, clozapine, olanzapine, aripiprazole, quetiapine, risperidone and ziprasidone in the database using the ratio of reported ratios (ROR) method in the ratio imbalance method and the combined criteria method (MHRA) to count and analyze the information related to the hematologic ADE signals. Results A total of 389431 ADE with six atypical antipsychotics as the first suspected drug were obtained from the FARES database, involving 116 706 reported cases. Hematologic ADE were reported in a total of 47144 cases, involving 9658 reported cases. Clozapine produced 22 hematologic signals, involving 6808 reported cases; olanzapine produced 19 hematologic signals, involving 736 reported cases. Quetiapine produced 18 hematologic signals, involving 560 reported cases. Aripiprazole produced 8 hematologic signals, involving 60 reported cases. Risperidone produced 3 hematologic signals, involving 16 reported cases. Ziprasidone produced 1 hematologic signal, involving 1 reported case. Risperidone produced 3 hematologic signals, involving 16 reported cases. Ziprasidone produced 1 hematologic signal, involving 5 reported cases. Conclusion Real-world atypical antipsychotic drug blood system ADE signal mining is helpful for safety evaluation and provides reference for clinical safety application.

四川省科技計(jì)劃項(xiàng)目（2019JDR0163）