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Received:March 28, 2023 Published Online:September 19, 2023
Received:March 28, 2023 Published Online:September 19, 2023
中文摘要: 目的 分析美国食品药品监督管理局公共数据开放项目（OpenFDA）中阿替利珠单抗和度伐利尤单抗的不良反应（ADR）报告情况，为临床合理使用提供参考。方法 根据OpenFDA ADR端点的交互式图标板块访问开放应用程序接口（API），检索2004年1月1日至2022年1月28日期间阿替利珠单抗和度伐利尤单抗的ADR报告数据。结果 共收到阿替利珠单抗和度伐利尤单抗的ADR报告分别13 630例、5 374例，男性ADR发生比例高于女性，其中阿替利珠单抗以发热、腹泻和肺炎最为常见；度伐利尤单抗常见的ADR为放射性肺炎，主要涉及肺组织炎症。除贫血、发热性中性粒细胞减少症和放射性肺炎外，阿替利珠单抗多数常见ADR的发生率和严重ADR的发生率与度伐利尤单抗相似。结论 通过OpenFDA数据库可快速、便捷对阿替利珠单抗和度伐利尤单抗的ADR情况进行挖掘和研究。随着两药的使用增多，其临床罕见的ADR日益突出，临床应加强用药监护，以促进其安全使用。
Abstract:Objective To analyze the adverse drug reactions (ADR) of atezolizumab and durvalumab based on the US Food and Drug Administration Public Data Open Project (OpenFDA) to provide reference for rational clinical use of drugs. Methods The ADR data of atezolizumab and durvalumab from January 1, 2004 to January 28, 2022 were retrieved through the application programming interface (API) access to the interactive icon panel of the OpenFDA ADR endpoint. Results A total of 13 630 and 5 374 ADR reports respectively related to atezolizumab and durvalumab were obtained. More cases were reported in males than in females. The most common ADR of atezolizumab were fever, diarrhea and pneumonia, and the common ADR of durvalizumab was radiation pneumonitis. The incidences of ADR and serious ADR were similar in atezolizumab and durvalumab, except the incidences of anemia, febrile neutropenia and radiation pneumonitis. Conclusion ADR of atezolizumab and durvalizumab can be quickly and conveniently excavated and studied based on the OpenFDA database. With the increase of the use of these two drugs, the rare ADR in clinic is increasingly prominent, so clinical medication monitoring should be strengthened to promote their safe use.
keywords: Atezolizumab Durvalumab US Food and Drug Administration Public Data Open Project Programmed cell death ligand 1 inhibitor Adverse reaction
文章编号： 中图分类号：R979 文献标志码：B
基金项目:江苏省药学会医院药学基金立项课题（A201713）；南京市卫生科技发展专项资金项目（GAX22280）
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