基于EudraVigilance数据库对阿替利珠单抗不良事件的挖掘和分析<sup>★</sup>

doi:10.3969/j.issn.2095-1264.2024.02.12

首页 > 过刊浏览>2024年第2期 >217-221. DOI:10.3969/j.issn.2095-1264.2024.02.12

基于EudraVigilance数据库对阿替利珠单抗不良事件的挖掘和分析★
DOI:
                        10.3969/j.issn.2095-1264.2024.02.12
                    
作者:
                        
                        
                    
作者单位:1.安徽医科大学附属亳州医院 药学部，安徽 亳州，236800;2.亳州学院，安徽 亳州，236800;3.蚌埠医科大学公共基础学院，安徽 蚌埠，233030
作者简介:狄潘潘，男，医学硕士，主管药师，研究方向：医院药学、数据挖掘与处理。
通讯作者:
中图分类号:R979.1
基金项目:★安徽医科大学校基金资助项目（2023xkj091）；亳州市人民医院院级科研项目（by2023006）。

Data mining and analysis of atezolizumab adverse events based on EudraVigilance medicines safety database^★

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Affiliation:

1.Department of Pharmacy, the Affiliated Bozhou Hospital of Anhui Medical University, Bozhou, 236800, Anhui, China;2.Bozhou University, Bozhou, 236800, Anhui, China;3.School of Public and Basic Medicine, Bengbu Medical University, Bengbu, 233030, Anhui, China

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摘要:

目的通过欧洲EudraVigilance（EV）数据库对阿替利珠单抗不良事件进行挖掘和分析，为临床安全用药提供参考。方法以阿替利珠单抗通用名“atezolizumab”为检索词，选择不同层级的MedDRA术语，提取EV数据库中所有与阿替利珠单抗相关的药品不良事件（ADE）报告进行分析。结果截至2022年7月30日，EV数据库共收集阿替利珠单抗相关ADE报告7 076例，发生ADE共12 766例次，其中严重不良事件11 721例次（91.81%）。患者以男性为主（56.83%），年龄集中在65~85岁（44.39%），上报人群主要为医务人员（94.16%）。对ADE进行系统器官分类（SOC），共涉及27个SOC，主要为全身性疾病及给药部位各种反应（13.17%）、胃肠系统疾病（9.33%）、呼吸系统、胸及纵隔疾病（8.69%）等。采用首选术语（PT）进行各系统报告查询，报告数前五位分别为发热、间质性肺病（ILD）、腹泻、肺炎和发热性中性粒细胞减少（FN）。结论阿替利珠单抗易导致严重不良反应，提示临床用药时应严格掌握其适应证，开展必要的药学监护，以保证患者用药安全。

Abstract:

Objective To mine and analyze the adverse drug events of atezolizumab through EudraVigilance (EV) database, so as to provide a reference for rational use of atezolizumab.Methods Taking the generic name of"atezolizumab"as the search term, different levels of MedDRA terms were selected, and all reports of adverse drug events (ADE) related to atezolizumab in the EV database were extracted and analyzed.Results As of Jul 30, 2022, 7 076 cases of ADEs related to atezolizumab were collected from EV database, and 12 766 cases of ADEs occurred, including 11 721 cases of serious adverse events (91.81%). The patients were mainly male (56.83%), aged 65~85 years (44.39%), and the reporting population was mainly medical personnel (94.16%). Totally 27 system organ classes (SOC) of ADEs were involved, mainly including general disorders and administration site conditions (13.17%), gastrointestinal diseases (9.33%), and respiratory, thoracic and mediastinal disorders (8.69%). The preferred term (PT) was used to query the reports of each SOC. The top five PTs in the number of reports were fever, interstitial lung disease(ILD), diarrhea, pneumonia and febrile neutropenia(FN).Conclusion Atezolizumab is easy to cause serious adverse reactions, suggesting that its indications should be strictly controlled and the necessary pharmaceutical care should be carried out to ensure the safety of patients.