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基于美国FAERS数据库的托珠单抗不良事件信号挖掘
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| 篇名： | 基于美国FAERS数据库的托珠单抗不良事件信号挖掘 |
| TITLE： | Data-mining of Adverse Drug Events Signals for Tocilizumab Based on US FAERS Database |
| 摘要： | 目的：挖掘托珠单抗的不良事件（ADE）信号，为其临床安全合理使用提供参考。方法：收集美国FDA不良反应报告系统中2015年第1季度至2020年第2季度共22个季度的托珠单抗相关ADE报告数据，经数据标准化后，采用比例失衡法进行ADE信号挖掘。结果：共提取以托珠单抗为首要怀疑药物的ADE报告163718份，涉及患者26674例。在26674例患者中，女性所占比例（73.69％）高于男性（19.04％），年龄以60～74岁（21.19％）为主。在163718份ADE报告中，报告国家以美国（70.15％）、加拿大（15.95％）、日本（3.33％）、澳大利亚（3.05％）、巴西（1.43％）为主；消费者（31.35％）和医师（24.94％）是主要上报人群。共挖掘出托珠单抗ADE信号747个，以类风湿性关节炎、关节痛、疼痛等较为常见，以残疾评估量表分数增加、残疾评估量表分数降低、舒张压异常、收缩压异常等信号较强；共发现托珠单抗药品说明书中未记录的ADE信号共33种，以血氧饱和度降低、血压降低、心率异常等实验室指标异常为主。ADE主要累及的系统器官共27个，涉及肌肉骨骼及结缔组织、全身性疾病以及给药部位各种反应、各类检查等。结论：临床应用托珠单抗时，除关注药品说明书中已提及的ADE外，还应密切关注血氧饱和度、血压、血常规等各项实验室指标，并在ADE发生时及早采取干预措施，以保证患者用药安全有效。 |
| ABSTRACT： | OBJECTIVE：To provide reference for clinical safe and rational drug use by mining adverse drug events （ADE） signals for tocilizumab. METHODS ：Data of ADE reports related to tocilizumab in the first quarter of 2015 to second quarter of 2020 were collected from US FDA adverse event reporting system. After data standardization ，the proportional imbalance method was used for ADE signal mining. RESULTS ：A total of 163 718 ADE reports were extracted ，in which tocilizumab was primary suspected drug ，involving 26 674 patients. In 26 674 patients，the proportion of female （73.69％）was higher than that of male （19.04％），and the age was mainly 60-74 years old （21.19％）. Among the 163 718 ADE reports ，the main reporting countries were the United States （70.15％），Canada（15.95％），Japan（3.33％），Australia（3.05％）and Brazil （1.43％）；consumers （31.35％）and doctors （24.94％）were the main reporting staff. A total of 747 ADE signals for tocilizumab were obtained ， commonly rheumatoid arthritis ，joint pain and pain ；and the signals as the increase of disability assessment scale score ，the decrease of disability assessment scale score ，abnormal diastolic blood pressure and abnormal systolic blood pressure were strong. A total of 33 kinds of ADE signals were found ，which were not recorded in the instructions of tocilizumab ，and mainly abnormal laboratory indicators such as decreased oxygen saturation ，decreased blood pressure and abnormal heart rate. ADE mainly involved 27 system organs ，including musculoskeletal and connective tissue ，various reactions of systemic diseases and drug delivery site ， various examinations. CONCLUSIONS ：In addition to the ADE mentioned in the drug instructions ，when using tocilizumab in clinic，attention should also be paid close to blood oxygen saturation ，blood pressure ，blood routine indexes and other laboratory indicators，and intervention measures should be taken early when ADE occurs ，so as to ensure the safety and effectiveness of drug use. |
| 期刊： | 2021年第32卷第15期 |
| 作者： | 罗林，张佳颖，陈力，龙恩武 |
| AUTHORS： | LUO Lin，ZHANG Jiaying ，CHEN Li，LONG Enwu |
| 关键字： | 托珠单抗；美国FDA不良事件报告系统；比例失衡法；不良事件；信号挖掘 |
| KEYWORDS： | Tocilizumab；US FDA adverse event reporting |
| 阅读数： | 374 次 |
| 本月下载数： | 15 次 |
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