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比较粒细胞集落刺激因子生物类似药与粒细胞集落刺激因子原药在挽救性化疗后恶性淋巴瘤中性粒细胞减少症管理中的应用。

Comparison between filgrastim biosimilar and filgrastim original for the management of neutropenia after salvage chemotherapy for malignant lymphoma.

机构信息

Department of Pharmacology, Toranomon Hospital, Tokyo, Japan.

Department of Hematology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.

出版信息

Int J Hematol. 2022 Dec;116(6):856-862. doi: 10.1007/s12185-022-03438-1. Epub 2022 Aug 17.

Abstract

In this study, the efficacy and safety of filgrastim biosimilar (F-BS) were retrospectively compared to those of filgrastim original in the treatment of malignant lymphoma with CHASE (± R) or DeVIC(± R) in 78 patients. The median number of filgrastim doses was 11 in the F-BS group and 8 in the filgrastim group after CHASE (± R) (p = 0.8), and 10 in the F-BS group and 10 in the filgrastim group after DeVIC (± R) (p = 0.45). The median days until neutrophil recovery to ≥ 1000/μL was 10 days with F-BS versus 10 days with filgrastim after CHASE ± R (p = 0.59), and 9 days with F-BS versus 10 days with filgrastim after DeVIC ± R (p = 0.828). Febrile neutropenia (FN) was observed in 5 patients (41.7%) in the F-BS group and 9 (52.9%) in the filgrastim group after CHASE ± R therapy (p = 0.616), and in 11 patients (36.7%) in the F-BS group and 9 (47.4%) in the filgrastim group after DeVIC ± R (p = 0.462). The present results suggest that the efficacy and safety of F-BS are comparable to those of filgrastim original, with no significant differences in clinical factors. Use of F-BS also reduced medical costs per course of CHASE ± R therapy by 170.22 US dollars.

摘要

在这项研究中,回顾性比较了在 78 例恶性淋巴瘤患者中使用 CHASE(±R)或 DeVIC(±R)时,培非格司亭生物类似药(F-BS)与培非格司亭原研药的疗效和安全性。在 CHASE(±R)后,F-BS 组的培非格司亭剂量中位数为 11 次,培非格司亭组为 8 次(p=0.8),F-BS 组和培非格司亭组在 DeVIC(±R)后分别为 10 次和 10 次(p=0.45)。中性粒细胞恢复至≥1000/μL 的中位天数,F-BS 组为 10 天,培非格司亭组为 10 天(p=0.59),F-BS 组为 9 天,培非格司亭组为 10 天(p=0.828)。在 F-BS 组中有 5 例(41.7%)和培非格司亭组中有 9 例(52.9%)患者出现发热性中性粒细胞减少症(FN)(p=0.616),在 F-BS 组中有 11 例(36.7%)和培非格司亭组中有 9 例(47.4%)患者出现发热性中性粒细胞减少症(FN)(p=0.462)。本研究结果表明,F-BS 的疗效和安全性与培非格司亭原研药相当,临床因素无显著差异。F-BS 的使用也使 CHASE(±R)治疗方案的每疗程医疗费用降低了 170.22 美元。

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