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在一家三级医院中,用利妥昔单抗治疗 B 细胞恶性肿瘤时,输注相关反应的发生率和风险因素。

The incidence and risk factors of infusion-related reactions to rituximab for treating B cell malignancies in a single tertiary hospital.

机构信息

Drug Safety Monitoring Center, Seoul National University Medical Research Center, Seoul, Republic of Korea.

出版信息

Oncology. 2014;86(3):127-34. doi: 10.1159/000357711. Epub 2014 Jan 29.

DOI:10.1159/000357711
PMID:24480856
Abstract

BACKGROUND

Rituximab is a chimeric anti-CD20 human/mouse monoclonal antibody. As its usage has increased, there have been growing concerns about rituximab-related infusion-related reactions (IRRs).

OBJECTIVE

The aim of this study is to verify the clinical features and risk factors of IRRs by rituximab, and to help establish clinical guidelines for their prevention.

METHODS

We reviewed electronic medical records of all the adult patients who were prescribed rituximab from January 2005 to July 2010 for B cell malignancy at Seoul National University Hospital.

RESULTS

A total of 389 cases of IRRs by rituximab (12.5% of a total of 3,104 infusions) were identified in 281 patients (49.4% of a total of 568 patients). IRRs most frequently occurred during the first infusion (40.5%) and abruptly decreased in subsequent infusions to rates of 3-8% (p < 0.001). The incidence of IRRs in patients premedicated with corticosteroid for their first infusion was significantly lower when compared to patients not pretreated with corticosteroid prior to rituximab infusion (8.3 vs. 41.2%, p = 0.017).

CONCLUSION

Almost half of all patients in the study experienced IRRs at least once during their scheduled rituximab treatment. Premedication with corticosteroid can be recommended in patients with high risk of IRR in the first infusion.

摘要

背景

利妥昔单抗是一种嵌合抗 CD20 人/鼠单克隆抗体。随着其应用的增加,人们对利妥昔单抗相关的输注相关反应(IRR)越来越关注。

目的

本研究旨在通过利妥昔单抗验证 IRR 的临床特征和危险因素,帮助制定其预防的临床指南。

方法

我们回顾了 2005 年 1 月至 2010 年 7 月期间在首尔国立大学医院因 B 细胞恶性肿瘤而接受利妥昔单抗治疗的所有成年患者的电子病历。

结果

在 281 例患者(568 例患者的 49.4%)中,共确定了 389 例利妥昔单抗引起的 IRR(总输注量的 12.5%)。IRR 最常发生在第一次输注期间(40.5%),并在随后的输注中急剧下降至 3-8%(p < 0.001)。与未在利妥昔单抗输注前预先使用皮质类固醇的患者相比,在第一次输注中预先使用皮质类固醇的患者发生 IRR 的发生率显著降低(8.3% vs. 41.2%,p = 0.017)。

结论

研究中几乎一半的患者在计划的利妥昔单抗治疗期间至少经历过一次 IRR。在第一次输注中具有高 IRR 风险的患者可以推荐预先使用皮质类固醇。

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