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复发/难治性 B 细胞恶性肿瘤住院患者 CAR-T 细胞治疗的管理:基于日本诊断程序组合数据库的分析

英文原题:Management of inpatient chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell malignancies: an analysis using the Japanese Diagnosis Procedure Combination database.

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Management of inpatient chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell malignancies: an analysis using the Japanese Diagnosis Procedure Combination database.

PubMed 2025/08/06(内容时间) Int J Hematol Q3 · IF 1.9(JCR 2025)

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中文摘要

CAR-T 细胞疗法在治疗复发/难治性B细胞恶性肿瘤方面显示出显著疗效,真实世界证据(RWE)也支持这一结论。然而,关于CAR-T 输注后围手术期不良事件管理的RWE仍然有限。

本研究旨在利用日本诊断程序组合数据库获取围手术期管理的RWE,该数据库是日本健康和医疗服务数据的综合存储库。2019年11月至2022年3月期间,388例患者接受了CAR-T 治疗。其中,312例患有大B细胞淋巴瘤(LBCL),76例患有B细胞急性淋巴细胞白血病(B-ALL)。CAR-T 输注数量每6个月间隔增加,与LBCL病例的增加相关。托珠单抗用于细胞因子释放综合征的治疗,在LBCL中占56.1%,在B-ALL中占42.1%。类固醇的使用率分别为22.9%和81.3%。大多数LBCL和B-ALL患者在CAR-T 输注期间接受了真菌感染预防治疗。治疗强度升级在LBCL中占2.8%,在B-ALL中占7.0%,约7%的患者启动了巨细胞病毒感染治疗。本分析基于患者的用药史阐明了围手术期管理策略。

展开英文摘要原文

Chimeric antigen receptor T-cell (CAR-T) therapy has shown remarkable efficacy in treating relapsed/refractory B-cell malignancies, as supported by real-world evidence (RWE).

However, limited RWE exists on the management of adverse events during the perioperative period following CAR-T infusion.

This study was conducted to obtain RWE on perioperative management using the Japanese Diagnosis Procedure Combination database, a comprehensive repository of Japanese health and medical service data. Between November 2019 and March 2022, 388 patients received CAR-T therapy. Of these, 312 had large B-cell lymphoma (LBCL) and 76 had B-cell acute lymphoblastic leukemia (B-ALL). The number of CAR-T infusions increased every 6-month interval, correlating with the rise in LBCL cases.

Tocilizumab was administered for cytokine release syndrome in 56. 1% of LBCL and 42. 1% of B-ALL patients. Steroids were used for 22. 9% and 81. 3%, respectively. Prophylaxis for fungal infections was administered during CAR-T infusion in most LBCL and B-ALL patients. Treatment intensity was escalated in 2. 8% of LBCL and 7. 0% of B-ALL patients, and treatment for cytomegalovirus infection was initiated in approximately 7% of patients. This analysis elucidated perioperative management strategies based on patients' medication histories.

论文信息

作者
Tanaka K、Kikuchi H、Umezawa Y、Mori T、Fushimi K、Yamamoto M
第一作者单位
Department of Hematology, Institute of Science Tokyo Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.Japan
通讯作者单位
Department of Hematology, Institute of Science Tokyo Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan. hide.hema@tmd.ac.jp.Japan
期刊
International journal of hematology2025 Dec
原文标识
PubMed 40770123 · DOI 10.1007/s12185-025-04043-8