基于FAERS数据库的瑞派替尼不良事件信号挖掘与分析  

Signal mining and analysis of adverse events of ripretinib based on FAERS database

作　　者：许毓颖 郑燕玲 潘伟萍 XU Yuying;ZHENG Yanling;PAN Weiping(Department of Pharmacy,2Medical Services Section,Jinjiang Municipal Hospital/Shanghai Sixth People's Hospital Fujian Campus,Quanzhou,362200,Fujian,China)

机构地区：[1]晋江市医院/上海市第六人民医院福建医院药学部,福建泉州362200 [2]晋江市医院/上海市第六人民医院福建医院医务科,福建泉州362200

出　　处：《肿瘤药学》2024年第6期753-759,共7页Anti-Tumor Pharmacy

摘　　要：目的 利用美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库挖掘瑞派替尼的药品不良事件(AE)信号,为临床合理用药提供参考。方法 采用报告比值比法(ROR)和比例报告比值法(PRR),对FAERS数据库中2020年第二季度至2023年第四季度瑞派替尼相关AE报告进行数据挖掘,使用《监管活动医学词典》26.1版本的系统器官分类(SOC)和首选术语(PT)将AE描述进行标准化,筛选出ROR法和PRR法共有信号进行分析。结果 共检索到2 869例AE报告,其中女性(54.02%)占比高于男性(43.71%)。在已知年龄的患者中,AE报告病例主要集中在≥65岁。通过筛选得到141个有效信号,涉及20个SOC分类,包括全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病、胃肠系统疾病等。其中,疲劳、脱发、疾病进展等AE发生频数较高;肿瘤压迫、皮肤角化症和雀斑等AE信号强度较高。此外,共挖掘到152个药品说明书未提及的PT信号,包括肌痉挛、皮肤干燥、乏力、肢体疼痛和体重降低等。结论 临床使用瑞派替尼时,应加强药学监护,定期监测,警惕肌痉挛、皮肤干燥、乏力、肢体疼痛和体重降低等药品说明书未提及的AE发生,如发生相关AE,应及时采取干预措施,保障患者用药安全。Objective To analyze the signals of adverse event(AE)of ripretinib by using the US FDA Adverse Event Reporting System(FAERS)database,and to provide reference for the clinical rational use of ripretinib.Methods Reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were used to mine the adverse reaction signals of ripretinib reported in the FAERS database from the second quarter of 2020 to the fourth quarter of 2023.The AE descriptions were standardized using the system organ classification(SOC)and preferred term(PT)of the Medical Dictionary for Regulatory Activities(MedDRA)version 26.1,and signals shared by ROR and PRR methods were screened for analysis.Results A total of 2869 adverse event reports were obtained,of which the pro‐portion of female patients(54.02%)was higher than that of male patients(43.71%).Among patients of known age,the reported AE cases were mainly concentrated in≥65 years old.A total of 141 effective signals were obtained,in‐volving 20 SOC categories,including general disorders and various reactions at the drug administration site,skin and subcutaneous tissue disorders and gastrointestinal disorders, etc. PTs with high frequency included fatigue, alo‐pecia, disease progression, etc. And PTs with high signal strength included tumor compression, skin keratosis, freck‐les. In addition, a total of 152 adverse event signals which were not mentioned in the instructions were discovered, including muscle spasms, dry skin, asthenia, pain in extremity, and weight loss. Conclusion In the clinical use of ripretinib, the pharmaceutical care should be strengthened, and the regular monitoring should be conducted. Be alert to the occurrence of AEs not mentioned in the instructions, such as muscle spasms, dry skin, asthenia, pain in extremity, and weight loss, etc. If any related AEs occur, timely intervention measures should be taken to ensure the safety of medication for patients.

关 键 词：瑞派替尼 不良事件 胃肠间质瘤 信号挖掘 比例失衡法 

分 类 号：R735[医药卫生—肿瘤] R979.1[医药卫生—临床医学]