使用JADER数据库对抗CD20抗体的Bendamustine进行细胞巨病毒发生率和发病时间分析
Kaori Ito1,2,3, Takenao Koseki2, Misaki Morisaku2
1Faculty of Pharmacy, Meijo University, Nagoya, Japan; itoka@meijo-u.ac.jp.
In vivo (Athens, Greece)
|February 28, 2024
概括
与Rituximab或Obinutuzumab的Bendamustine组合疗法可能会增加淋巴瘤患者的细胞巨型病毒 (CMV) 感染持续时间. 建议在治疗后对细胞介导免疫的进一步研究.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 药物监督 药物监督 药物监督
背景情况:
- 患有恶性淋巴瘤的患者免疫功能减弱,增加了化疗诱导的免疫抑制和细胞巨乳病毒 (CMV) 感染的风险.
- 同时使用班达穆斯丁和瑞图西马布或奥比努图祖马布的治疗加剧了免疫抑制,可能会影响CMV的发病.
研究的目的:
- 评估bendamustine单疗法和与rituximab或obinutuzumab联合治疗之间的CMV发病的差异.
- 使用日本药物不良事件报告数据库 (JADER) 进行分析.
主要方法:
- 分析了2004年4月至2022年9月的JADER数据.
- 使用MedDRA首选术语定义的CMV感染.
- 计算的报告几率比率 (ROR) 对于CMV信号的bendamustine单疗法,修仙药,奥比努图祖马布,bendamustine+rituximab (BR),和bendamustine+obinutuzumab (GB).
主要成果:
- 在单疗法和组合疗法中证实了CMV信号.
- 平均CMV感染持续时间为bendamustine单疗41.0天,BR为63.5天,GB为61.0天.
- 一些CMV感染病例超过200天.
结论:
- 在JADER分析中,发现了与rituximab,obinutuzumab和bendamustine相关的显著CMV信号.
- 建议对可能的CMV再激活在bendamustine给药7-9个月后保持谨慎.
- 需要对细胞介导免疫抑制进行进一步的研究.
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