基于FAERS数据库比较三种新型雄激素受体阻滞剂的安全性
作者:
作者单位:

1.首都医科大学附属北京友谊医院 药学部,北京,100050;2.首都医科大学药学院 临床药学系,北京,100069

作者简介:

杨佳钰,女,硕士研究生,研究方向为临床药学。

通讯作者:

侯文婧,女,副主任药师,研究方向为临床药学。

中图分类号:

R737.25;R979.1

基金项目:


Safety comparison of three novel androgen receptor inhibitors based on the FAERS database
Author:
Affiliation:

1.Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China;2.Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Capital Medical University, Beijing, 100069, China

Fund Project:

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    摘要:

    目的 基于FAERS数据库对恩扎卢胺、阿帕他胺和达罗他胺进行药品不良事件(ADE)信号挖掘,为临床安全用药提供参考。方法 提取FAERS数据库中三种药品自上市至2023年第1季度的报告数据,采用报告比值比(ROR)法和比例报告比值(PRR)法对三种药品的ADE信号进行挖掘。结果 共得到恩扎卢胺相关ADE信号135个,涉及14个系统器官分类(SOC),其中说明书未收录的信号有98个;阿帕他胺相关ADE信号77个,涉及16个SOC,其中说明书未收录的信号有46个;达罗他胺相关ADE信号29个,涉及13个SOC,其中说明书未收录的信号有23个。比较不同药品的所有ADE信号,发现恩扎卢胺相关信号主要分布在各类神经系统疾病(头晕、味觉障碍、记忆受损、平衡障碍、失忆症、周围神经病等)、胃肠系统疾病(吞咽困难、便秘、腹部不适等)、各类肌肉骨骼及结缔组织疾病(背痛、肌无力、肌肉骨骼疼痛等),阿帕他胺相关信号主要分布在皮肤及皮下组织类疾病(皮疹、史蒂文斯-约翰逊综合征、红斑性皮疹、瘙痒性皮疹等),达罗他胺相关信号则主要分布在各类检查(血肌酐升高、肝酶升高等)、肾脏及泌尿系统疾病(肾功能损害等)。结论 本研究挖掘到的ADE信号验证了三种药品说明书中的安全性内容,药品说明书未收录的信号尚需进一步评估。不同药品的ADE有所差异,应结合患者病史及用药史进行选择。

    Abstract:

    Objective To mine the signals of adverse drug events (ADE) of the novel androgen receptor inhibitors (enzalutamide, apalutamide and darolutamide) based on the FAERS database, so as to provide reference for clinical safe drug use.Methods The reported data of the three drugs from marketing to the first quarter of 2023 were extracted from the FAERS database, and the reported odds ratio (ROR) method and proportional reporting ratio (PRR) method were used to mine the ADE signals of the three drugs.Results A total of 135 ADE signals were obtained for enzalutamide, involving 14 system organ classes (SOCs). Of the 135 signals, 98 signals were not included in the instruction of enzalutamide. There were 77 ADE signals for apalutamide, involving 16 SOCs, and 46 signals of them were not included in the instruction of apalutamide. Totally 29 ADE signals were obtained for darolutamide, involving 13 SOCs, and 23 signals of them were not included in the instruction of darolutamide. Comparing all ADE signals for different drugs, it was found that enzalutamide-related signals were mainly about the nervous system diseases (dizziness, taste disorder, impaired memory, balance disorder, amnesia, peripheral neuropathy, etc.), gastrointestinal system diseases (dysphagia, constipation, abdominal discomfort, etc.) and musculoskeletal and connective tissue diseases (back pain, muscular weakness, musculoskeletal pain, etc.). Apalutamide-related signals were mainly about the skin and subcutaneous tissue disorders (rash, Stevens-Johnson syndrome, pruritic rash, erythematous rash, etc.), while darolutamide-related signals were mainly distributed in various examinations (elevated serum creatinine, elevated liver enzymes, etc.), and kidney and urinary system diseases (renal function damage, etc.).Conclusion The ADE signals involved in this study verified the safety content in the instructions of the three drugs, and the signals not included in the instructions need to be further evaluated. The ADEs of different drugs were different, so it is better to choose drugs on the base of patient's medical history and medication history.

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杨佳钰,王维娜,温爱萍,何超然,侯文婧.基于FAERS数据库比较三种新型雄激素受体阻滞剂的安全性[J].肿瘤药学,2024,14(5):614-620 ( in Chinese)

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