[关键词]
[摘要]
目的 基于美国食品药品监督管理局(FDA)不良事件报告系统(FDA adverse event reporting system,FAERS)数据库对托法替尼的不良事件信息进行对比分析,挖掘其潜在的药品不良反应信号,以期为临床安全合理用药提供参考依据。方法 从FAERS数据库中提取2011—2022年托法替尼的不良事件报告数据,利用报告比值比法(report the odds ratio,ROR)和比例报告比值法(proportional report ratio,PRR)对托法替尼的报告进行数据挖掘。利用国际医学用语词典术语集进行汉化及系统/器官(system organ class,SOC)归类得到有效信号。结果 纳入的65 535份报告中,女性患者多于男性,年龄主要集中在50~75岁,上报国家主要为美国;利用ROR和PRR法筛选后共得到545个信号,经系统器官分类后主要集中在各类肌肉骨骼及结缔组织病、各类神经系统疾病、全身性疾病及给药部位反应、感染及侵染类疾病、呼吸系统、胸及纵膈疾病等,其中报告数较多的依次为疼痛、关节痛、状态恶化、类风湿性关节炎等,信号强度依次为硫嘌呤甲基转移酶下降、沮丧、免疫恢复性葡萄膜炎、红细胞沉降率异常等。同时本研究检测到良性、恶性及性质不明的肿瘤、心脏等方面安全信号。结论 有效利用ROR法和PRR法挖掘托法替尼的不良反应信号可为临床用药提供一定的参考,有利于促进临床合理用药。
[Key word]
[Abstract]
Objective Adverse event information of tofacitinib was analyzed and compared based on the FDA adverse event reporting system (FAERS) database, and potential adverse drug reaction signals of tofacitinib were explored. In order to provide reference for clinical safe and rational drug use. Methods Adverse event report data of tofacitinib from 2011 to 2022 were extracted from FAERS database, and proportional report ratio (ROR) and report the odds ratio (ROR) were applied. Effective signals were obtained by sinicization and system organ class (SOC) classification using the International Dictionary of Medical Terms. Results Among the 65 535 reports included, female patients were more than male patients, and the age group was mainly between 50 and 75 years old. The reporting countries were mainly the United States. A total of 545 signals were obtained after screening by ROR and PRR methods, which were mainly classified into various musculoskeletal and connective tissue diseases, nervous system diseases, systemic diseases and drug site reactions, infections and infective diseases, respiratory system, chest and mediastinum diseases, etc. Among them, pain, arthralgia, state deterioration, rheumatoid arthritis were the most reported, and the signal intensity was successively decreased thiopurine methyltransferase, depression, immune restorative uveitis, abnormal erythrocyte subsidence rate and so on. At the same time, benign, malignant, and unknown tumors, heart and other safety signals were detected in this study. Conclusions In this study, ROR method and PRR method were effectively used to excavate the adverse reaction signals of tofacitinib, which could provide certain reference for clinical drug use and promote rational clinical drug use.<
[中图分类号]
R976
[基金项目]