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On-line Access: 2021-02-07

Received: 2020-08-07

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 ORCID:

Xia-hong Lin

https://orcid.org/0000-0002-5515-730X

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Journal of Zhejiang University SCIENCE B 2021 Vol.22 No.2 P.156-164

http://doi.org/10.1631/jzus.B2000449


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


Author(s):  Sifu HUANG, Xuefeng BAI, Taiyong FANG, Yanta GUO, Kainan ZHENG, Xiahong LIN

Affiliation(s):  Department of Gastroenterology, the Second Affiliated Hospital of Fujian Medical University, Quanzhou 362000, China; more

Corresponding email(s):   linxiahongdr@fjmu.edu.cn

Key Words: 


Sifu HUANG, Xuefeng BAI, Taiyong FANG, Yanta GUO, Kainan ZHENG, Xiahong LIN. Gastrointestinal toxicities associated with immune checkpoint inhibitors: a disproportionality analysis leveraging VigiBase, the WHO Adverse Drug Reaction Database[J]. Journal of Zhejiang University Science B, 2021, 22(2): 156-164.

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author="Sifu HUANG, Xuefeng BAI, Taiyong FANG, Yanta GUO, Kainan ZHENG, Xiahong LIN",
journal="Journal of Zhejiang University Science B",
volume="22",
number="2",
pages="156-164",
year="2021",
publisher="Zhejiang University Press & Springer",
doi="10.1631/jzus.B2000449"
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%0 Journal Article
%T Gastrointestinal toxicities associated with immune checkpoint inhibitors: a disproportionality analysis leveraging VigiBase, the WHO Adverse Drug Reaction Database
%A Sifu HUANG
%A Xuefeng BAI
%A Taiyong FANG
%A Yanta GUO
%A Kainan ZHENG
%A Xiahong LIN
%J Journal of Zhejiang University SCIENCE B
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%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.B2000449

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T1 - Gastrointestinal toxicities associated with immune checkpoint inhibitors: a disproportionality analysis leveraging VigiBase, the WHO Adverse Drug Reaction Database
A1 - Sifu HUANG
A1 - Xuefeng BAI
A1 - Taiyong FANG
A1 - Yanta GUO
A1 - Kainan ZHENG
A1 - Xiahong LIN
J0 - Journal of Zhejiang University Science B
VL - 22
IS - 2
SP - 156
EP - 164
%@ 1673-1581
Y1 - 2021
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.B2000449


Abstract: 
With the improvement of people's living standards, gastrointestinal adverse reactions caused by various adverse factors have attracted more and more people's attention. A recent study has indicated that coronavirus disease 2019 (COVID-19) could also invade the gastrointestinal tract, leading to gastrointestinal adverse reactions (Song et al., 2020). In recent years, immunotherapy has provided certain effects for some patients with advanced malignant tumors. A microencapsulation of immunoglobulin Y (IgY) was reported to provide an effective way to preserve IgY and improve its performance in the gastrointestinal tract (Zhang J et al., 2020). Immune checkpoint inhibitors (ICIs) can significantly improve the survival of some advanced malignant tumors, especially metastatic malignant melanoma and lung cancer (Afzal et al., 2018; Madden and Kasler, 2019). They include anti-cytotoxic T lymphocyte-associated antigen-4 (anti-CTLA-4) antibodies (ipilimumab and tremelimumab), anti-programmed cell death protein 1 (anti-PD-1) antibodies (nivolumab and pembrolizumab), and anti-programmed death-ligand 1 (anti-PD-L1) antibodies (atezolizumab, avelumab, and durvalumab) (Baxi et al., 2018). Previous studies have shown that ICI combination therapy, such as nivolumab plus ipilimumab, has particular efficacy in lung cancer, renal cell carcinoma, and malignant melanoma (Wolchok et al., 2017; Derosa et al., 2018; Doroshow et al., 2019). However, ICIs may also lead to many immune-related adverse events (irAEs), even causing severe complications in certain cases. The most well-established toxicities from ICI therapy are gastrointestinal irAEs, including enteritis, enterocolitis, microscopic colitis, and gastritis, which have attracted public attention in recent years; reports of such events associated with ICI therapy also have increased (Tandon et al., 2018; de Malet et al., 2019). These gastrointestinal irAEs may generally respond well to corticosteroids and infliximab (Haanen et al., 2017). Although most of these irAEs are low-grade, a lack of detection and timely treatment may incur severe or fatal complications.

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.

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。

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

Darkslateblue:Affiliate; Royal Blue:Author; Turquoise:Article

Reference

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