非典型抗精神病药物血液系统不良事件信号挖掘和数据分析

Mining and data analysis of hematological adverse drug event signals of atypical antipsychotics

目的基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)挖掘6种非典型抗精神病药物氯氮平、奥氮平、阿立哌唑、喹硫平、利培酮、齐拉西酮血液系统不良事件(ADE)信号,为临床安全使用非典型抗精神病药物提供参考。方法下载2017年第1季度—2021年第3季度共19个季度的FAERS数据,采用比值失衡法中的报告比值比(ROR)法和综合标准法(MHRA)检测数据库中非典型抗精神病药物的ADE信号,统计并分析血液系统ADE信号的相关信息。结果从FAERS数据库得到以氯氮平、奥氮平、阿立哌唑、利培酮、喹硫平、齐拉西酮6种非典型抗精神病药物为首要怀疑药物的ADE共389431例次,涉及报告病例116706例。血液系统ADE报告共计47144例次,涉及报告病例9658例。氯氮平产生血液系统信号22个,涉及报告病例6808例;奥氮平产生血液系统信号19个,涉及报告病例736例;喹硫平产生血液系统信号18个,涉及报告病例560例;阿立哌唑产生血液系统信号8个,涉及报告病例60例;利培酮产生血液系统信号3个,涉及报告病例16例;齐拉西酮产生血液系统信号1个,涉及报告病例5例。结论基于真实世界的非典型抗精神病药物血液系统ADE信号挖掘有助于开展安全性评价,为临床安全应用提供参考。

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 389 431 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 47 144 cases, involving 9 658 reported cases. Clozapine produced 22 hematologic signals, involving 6 808 reported cases;olanzapine produced 19 hematologic signals, involving 736 reported cases. Quetiapine produced 18 hematologic signals, involving560 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 3hematologic 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.