| Hao Liu,Yujing Zhang,Jingyi Li,Rong Yan. Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database. Oncol Transl Med, 2021, 7: 88-94. |
| 阿特朱单抗不良反应分析——基于FAERS数据库的真实世界研究 |
| Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database |
| Received:July 13, 2020 Revised:April 08, 2021 |
| DOI：10.1007/s10330-020-0444-4 |
| 中文关键词: 阿特朱单抗；不良反应；FAERS数据库；合理用药 |
| 英文关键词: atezolizumab; adverse reactions; Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database; rational drug use |
| 基金项目: |
| Author Name | Affiliation | Department | | Hao Liu | The First Affiliated Hospital of Xi''an Jiaotong University, Xi''an , China | Department of Surgical Oncology | | Yujing Zhang | The First Affiliated Hospital of Xi''an Jiaotong University, Xi''an , China | Department of Surgical Oncology | | Jingyi Li | Xi''an Jiaotong University, Xi''an , China | College of Stomatology | | Rong Yan* | The First Affiliated Hospital of Xi''an Jiaotong University, Xi''an , China | Department of Surgical Oncology |
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| 中文摘要: |
| 目的：通过对美国FAERS数据库中阿特朱单抗不良反应的统计分析，揭示阿特朱单抗不良反应的规律性，挖掘与阿特朱单抗显著相关的不良反应信号，为临床合理用药提供参考。方法：对美国FAERS数据库2017-2019年4796例阿特朱单抗不良反应事件进行回顾性研究和分析。结果：阿特朱单抗相关的不良反应事件排名前三位的别是热性贫血（3.7%）、贫血（2.9%）和急性肾功能衰竭（2.3%），并且一些不良反应的发生率在不同性别和年龄上有统计学差异。不良反应事件的系统器官分类（SOC）涉及32个系统，前三位分别是血液和淋巴系统疾病585例（12.2%），胃肠道紊乱疾病433例（9.0%），感染和感染401例（8.4%）。采用报告比值比（ROR）法检测阿特朱单抗的不良反应信号，最严重的不良反应发热性贫血的ROR[95%Cl]为39.236[33.757,45.604]。结论：FAERS数据库中的不良反应与阿特朱单抗说明书中的不良反应基本一致。阿特朱单抗具有可接受且可控的疗效。 |
| 英文摘要: |
| Objective In this study, we aimed to determine the incidence of adverse drug reactions (ADRs) of
atezolizumab, identify ADR signals that are significantly related to atezolizumab, and provide a reference
for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events
(ADEs) reported in the American Food and Drug Administration (FDA) Adverse Event Reporting System
(FAERS) database.
Methods In total, 4796 cases of atezolizumab ADEs reported in the American FAERS database from
2017 to 2019 were retrospectively analyzed.
Results The top three ADEs were febrile neutropenia (3.7%), anemia (2.9%), and acute renal failure
(2.3%). In addition, the incidence rates of some ADEs were significantly different according to sex and age.
The systematic organ classification of atezolizumab ADEs involved 32 systems, among which the top three
were blood and lymphatic system disorders (585 cases, 12.2%), gastrointestinal disorders (433 cases,
9.0%), and infections and infestations (401 cases, 8.4%). The reporting odds ratio (ROR) method was
used to detect the ADR signals of atezolizumab. The ROR (95% confidence interval) of the top ADE, febrile
neutropenia, was 39.236 (33.757–45.604). In addition, we found 121 cases of complications associated
with immune-related ADEs.
Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those
mentioned in the instructions for atezolizumab use, suggesting that atezolizumab has an acceptable and
controllable drug effect. |
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