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CAR-T 细胞治疗后的眼部不良事件:一项药物警戒研究与系统综述

英文原题:Ocular adverse events following CAR-T cell therapy: A pharmacovigilance study and systematic review.

查看英文原题

Ocular adverse events following CAR-T cell therapy: A pharmacovigilance study and systematic review.

PubMed 2024/03/28(内容时间) Eur J Haematol Q2 · IF 2.6(JCR 2025)

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中文摘要

包括CAR-T 细胞治疗在内的肿瘤免疫疗法兴起,带来了新一轮癌症治疗浪潮,尤其是在血液系统恶性肿瘤领域。然而,其不良事件数据,特别是眼部不良事件,报告不足。为评估6种获美国食品药品监督管理局(FDA)批准的CAR-T 细胞疗法相关眼部不良事件,研究者利用FAERS数据库对2017年第一季度至2023年第三季度的数据开展不均衡性分析,并系统综述截至2023年12月20日CAR-T 治疗后眼部事件的病例报告。研究从FDA的FAERS数据库中识别出53例眼部不良事件。最常见事件为接受tisagenlecleucel(Kymriah)治疗后的瞳孔扩大和干眼。本系统综述纳入8篇病例报告,涉及19例患者,共报告27起事件。本研究表明,眼科医生和肿瘤科医生应预先关注潜在眼部不良事件,因为此类事件可能显著增加癌症患者的疾病负担。

展开英文摘要原文

The rise of immuno-oncology, including the use of chimeric antigen receptor T-cell (CAR-T) therapy is bringing in a new wave of cancer treatments, particularly in hematologic malignancies.

However, data on their adverse events, particularly of the eye, is under-reported. To assess the ocular adverse events associated with the six FDA-approved CAR-T cell therapies, a disproportionality analysis utilizing the FAERS database was conducted from the first quarter of 2017 to the third quarter of 2023, as well as a systematic review of case reports of ocular events following CAR-T cell therapy up to December 20, 2023.

A total of 53 ocular adverse events were identified from the FDAs FAERS database. The adverse events most frequently observed were mydriasis and xerophthalmia with tisagenlecleucel (Kymriah). The systematic review resulted in 8 case reports encompassing 19 patients which included a total of 27 events.

This study demonstrates the importance of anticipation of potential ocular adverse events by ophthalmologists and oncologists as they can greatly contribute to morbidity in patients with cancer.

论文信息

作者
Frey C、Cherniawsky H、Etminan M
第一作者单位
Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.Canada
通讯作者单位
Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada.Canada
文献类型
系统综述
期刊
European journal of haematology2024 Jul
原文标识
PubMed 38549191 · DOI 10.1111/ejh.14208