Gastrointestinal toxicities associated with immune checkpoint inhibitors: a disproportionality analysis leveraging VigiBase, the WHO Adverse Drug Reaction Database

与免疫检查点抑制剂相关的胃肠道毒性: 利用 WHO 药物不良反应数据库 VigiBase 进行的不成比例分析

概要

目的

免疫检查点抑制剂 (ICIs) 可以显著提高某些晚期恶性肿瘤的生存率, 但是, ICIs 治疗也可能导致许多免疫相关的不良反应事件. 我们的研究旨在鉴定和表征与 ICIs 相关的胃肠道不良反应事件.

创新点

鉴定和表征与 ICIs 相关的胃肠道不良反应事件, 提高对 ICIs 所致胃肠道不良事件的认识.

方法

从世界卫生组织 (WHO) 药物不良反应数据库 VigiBase 获得 2011 年 1 月 1 日至 2019 年 3 月 6 日的药物不良反应数据, 将接受 ICIs 治疗报告的胃肠道不良反应事件与整个数据库报告进行比较. 通过计算信息成分 (IC) 和报告优势比 (ROR) 评估 ICIs 与胃肠道不良反应事件之间的关联.

结论

ICIs 治疗可导致多种胃肠道不良反应事件, 甚至可发生严重巨结肠. 对于晚期恶性肿瘤患者进行 ICIs 临床诊疗时, 需要考虑 ICIs 相关胃肠道不良反应事件.

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Acknowledgments

The supplied data come from various sources from VigiBase, and the probability that the suspected adverse effect is drug-related is not the same in all cases. The information does not represent the opinion of the Uppsala Monitoring Center or the WHO. Camilla Westerberg of the custom search team at the Uppsala Monitoring Centre (Uppsala, Sweden) research department is thanked for his help with the data extraction.

Author information

Affiliations

Authors

Contributions

The study design was created by Xiahong LIN. Data collection and analysis was performed by Sifu HUANG, Xuefeng BAI, and Kainan ZHENG. Taiyong FANG and Yanta GUO conducted the literature search. Sifu HUANG and Xuefeng BAI wrote and edited the manuscript, and they contributed equally to this study. Xiahong LIN, Sifu HUANG, and Xuefeng BAI were responsible for the final modification of the manuscript. All authors have read and approved the final version of the manuscript.

Corresponding author

Correspondence to Xiahong Lin.

Ethics declarations

Sifu HUANG, Xuefeng BAI, Taiyong FANG, Yanta GUO, Kainan ZHENG, and Xiahong LIN declare that they have no conflicts of interest.

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Huang, S., Bai, X., Fang, T. et al. Gastrointestinal toxicities associated with immune checkpoint inhibitors: a disproportionality analysis leveraging VigiBase, the WHO Adverse Drug Reaction Database. J. Zhejiang Univ. Sci. B 22, 156–164 (2021). https://doi.org/10.1631/jzus.B2000449

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关键词

  • 免疫检查点抑制剂
  • 胃肠道毒性
  • VigiBase
  • 信息成分
  • 报告优势比