| アブストラクト | BACKGROUND: Acute kidney injury (AKI) is a rare but severe adverse event of immune checkpoint inhibitors (ICIs). With the increasing reports of ICIs, it's necessary to put new insights into ICIs-related AKI. We conducted a systematic review of randomized controlled trials(RCTs) and a real-world study by extracting data from the US FDA Adverse Event Reporting System (FAERS) database. METHODS: We explored ICIs-related AKI events in RCTs available in ClinicalTrials.gov and electronic databases (PubMed, Cochrane Library, Embase) up to August 2021. Meta-analysis was performed by using risk ratios (RRs) with 95 %CIs. In a separate retrospective pharmacovigilance study of FAERs, disproportionality was analyzed using the proportional reports reporting odds ratio (ROR) and information components (IC). RESULTS: A total of 79 RCTs (500,09 patients) were included, and ICIs were associated with increased risk of all-grade (RR = 1.37, 95 %CI:1.14-1.65) and high-grade AKI (RR = 1.60, 95 %CI:1.16-2.20). Results of subgroup analysis indicated that RR of ICI-related AKI did not vary significantly by cancer type, treatment regimen (monotherapy or combination of ICIs), study design (double-blind or open-label), individual ICIs and publication status (published or unpublished). FAERS pharmacovigilance data identified 1918 cases of AKI related to ICIs therapy. ICIs were significantly associated with over-reporting frequencies of AKI (ROR = 2.38, 95 %CI:2.27-2.49; IC = 1.22, 95 %CI:1.16-1.27). The median onset time of AKI was 48 days, 77.5 % of patients discontinued the use of ICIs, and 15.9 % of patients resulted in death. CONCLUSIONS: These data suggest that ICIs were significantly associated with increased risk of AKI in both trial settings and clinical practice. |
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| ジャーナル名 | International immunopharmacology |
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| 投稿日 | 2022/10/23 |
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| 投稿者 | Zhu, Jianhong; Wu, Jialing; Chen, Pengwei; You, Kaiyun; Su, Jianan; Gao, Ziqing; Bi, Zhuofei; Feng, Min |
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| 組織名 | Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene;Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, China;;Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Sun Yat-sen University,;China.;Department of Radiation Oncology, Sun Yat-Sen Memorial Hospital, Sun Yat-sen;University, China.;Department of Nephrology, Sun Yat-Sen Memorial Hospital, Sun Yat-sen University,;University, China. Electronic address: bizhuof@mail.sysu.edu.cn.;China. Electronic address: fengmin3@mail.sysu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36272360/ |
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