基于FAERS数据库的5种ALK-TKIs不良事件信号挖掘
作者:
作者单位:

1.四川大学华西第二医院,儿科,四川 成都,610041;2.四川大学华西第二医院,药学部,四川 成都,610041;3.四川大学华西第二医院,产科,四川 成都,610041;4.出生缺陷与相关妇儿疾病教育部重点实验室,四川 成都,610041;5.四川大学华西药学院,四川 成都,610041

作者简介:

戚雨婷,女,临床药学本科,研究方向:临床药学。

通讯作者:

王慧卿,女,副主任医师,研究方向:儿科学、模拟医学教育。

中图分类号:

R979.1

基金项目:

四川省科技厅重点研发项目(2020YFS0083)。


Signal mining of five ALK-TKIs adverse events based on FAERS database
Author:
Affiliation:

1.Department of Pediatrics,;2.Department of Pharmacy,;3.Department of Obstetrics, West China Second Hospital, Sichuan University, Chengdu, 610041, Sichuan, China;4.Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, 610021, Sichuan, China;5.West China School of Pharmacy, Sichuan University, Chengdu, 610041, Sichuan, China

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    摘要:

    目的 基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库,对间变性淋巴瘤激酶-酪氨酸激酶抑制剂(ALK-TKI)的不良事件(ADE)进行数据挖掘,为临床安全用药提供依据。方法 提取FAERS数据库中2019年第一季度至2022年第二季度共14个季度5种ALK-TKIs(第一代的克唑替尼,第二代的色瑞替尼、布加替尼、阿来替尼和第三代的劳拉替尼)的ADE数据,经过去重、数据清洗,采用报告比值比法(ROR)、比例报告比值比法(PRR)进行信号挖掘。结果 筛选出5种ALK-TKIs为首要怀疑药物的ADE报告共8 444份,进行分析处理后,共计得到563个ADE信号,去除产品问题、社会环境、各类损伤、中毒、及操作并发症和各种手术及医疗操作等无关信号后,共累及20个系统/器官分类(SOC)。结论 5种ALK-TKIs累及的SOC差异较大,临床应用该药物时应特别注意对全身性疾病的监测。本研究获得的常见ADE信号与说明书具有一定的一致性,证明了研究方法的可靠性。临床使用这5种ALK-TKIs时应考虑不同药物的特点,进行个体化给药。

    Abstract:

    Objective To mine the adverse events (ADE) data of anaplastic lymphoma kinase-tyrosine kinase inhibitor (ALK-TKI) on the base of the United States Food and Drug Administration (FDA) adverse event reporting system (FAERS) database, so as to provide the basis for clinical safe use of drugs.Methods ADE data of five ALK-TKIs (the first generation of crizotinib, the second generation of ceritinib, brigatinib, alectinib, and the third generation of lorlatinib) in 14 quarters from the first quarter of 2019 to the second quarter of 2022 were extracted from FAERS database. After deduplication and data cleaning, signal mining was performed using reporting odds ratio (ROR) and proportional reporting ratio (PRR).Results A total of 8 444 ADE reports with five ALK-TKIs as the primary suspected drugs were screened out, and 563 ADE signals were obtained after analysis and processing. After removing the irrelevant signals such as product problems, social environment, various injuries, poisoning, and operation complications as well as various operations and medical treatments, a total of 20 kinds of system/organ class (SOC) were affected.Conclusion The SOCs involved by the five ALK-TKIs varied greatly, so special attention should be paid to the monitoring of systemic diseases when these drugs used clinically. The common ADE signals obtained in this study were consistent with the specifications to a certain extent, proving the reliability of the research method. The clinical use of the five ALK-TKIs should be individualized considering the characteristics of different drugs.

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戚雨婷,刘怿晗,陈力,王国玉,王慧卿.基于FAERS数据库的5种ALK-TKIs不良事件信号挖掘[J].肿瘤药学,2023,13(4):480-489 ( in Chinese)

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  • 在线发布日期: 2023-11-07
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