| アブストラクト | BACKGROUND: An increasing number of clinical studies have highlighted the use of atezolizumab in tumor immunotherapy. However, There is still a lack of comprehensive research on its associated adverse events (AEs). To improve our understanding of its toxicological profile and to provide valuable clinical insights regarding into the effectiveness of immunotherapy, this study utilized data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) to conduct a retrospective analysis of AEs linked to atezolizumab. METHODS: We extracted the reports of AEs related to atezolizumab from the FAERS database from the first quarter of 2004 to the first quarter of 2024. We quantified them using the reporting odds ratio (ROR) and proportional reporting ratio (PRR), along with chi-square value (chi(2)), and conducted systematic classification of the AE signal mining results through SAS 9.4 software. RESULTS: A total of 19,563 valid reports were incorporated, involving 20 distinct system organ class categories. The AEs related to atezolizumab, reported at the preferred term level, mainly encompassed anemia [ROR 2.33, 95% confidence interval (CI) lower limit 2.09, PRR 2.31, chi(2) 255.977], febrile neutropenia (ROR 2.81, 95% CI lower limit 2.50, PRR 2.79, chi(2) 333.586), neutrophil count decreased (ROR 2.14, 95% CI lower limit 1.89, PRR 2.13, chi(2) 150.688), white blood cell count decreased (ROR 2.35, 95% CI lower limit 2.03, PRR 2.34, chi(2) 136.673), sepsis (ROR 2.21, 95% CI lower limit 1.91, PRR 2.20, chi(2) 117.741), alanine aminotransferase increased (ALT) (ROR 2.86, 95% CI lower limit 2.44, PRR 2.85, chi(2) 180.031), and aspartate aminotransferase increased (AST) (ROR 2.79, 95% CI lower limit 2.38, PRR 2.78, chi(2) 170.955). CONCLUSIONS: Apart from various degrees of hepatotoxicity, such as increased ALT and AST, the immune-related hematological toxicity of atezolizumab should also be noted. In clinical practice, healthcare providers should always be vigilant for the occurrence of such medication-related AEs and take measures to enhance the safety of clinical medication use. |
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| ジャーナル名 | BMC pharmacology & toxicology |
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| Pubmed追加日 | 2025/3/5 |
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| 投稿者 | Li, Zhuoyang; Zhu, Ning; Liu, Yuwei; Yu, Yan; Wang, Tianhong; Zou, Congcong; Wang, Siman; Ou, Xiaofeng |
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| 組織名 | School of Medicine, Wuhan University of Science and Technology, Wuhan, 430065,;China.;Division of Head & Neck Tumor Multimodality Treatment, Cancer Center, West China;Hospital, Sichuan University/West China School of Nursing, Sichuan University,;Chengdu, Sichuan Province, China.;West China School of Public Health and West China Fourth Hospital, Sichuan;University, Chengdu, China.;The Department of Clinical Research, West China Hospital, Sichuan University,;Chengdu, 610041, China.;Anesthesia and Surgery Center of West China Xiamen Hospital, Sichuan University,;699 Jinyuan West Road, Xingbin Street, Jimei District, Xiamen, Fujian Province,;Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu,;610041, China.;Department of Critical Care Medicine, West China Hospital of Sichuan University,;Chengdu, Sichuan Province, China. hxxiaoou@126.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40038564/ |
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