药物与临床

利妥昔单抗联合CHOP 方案治疗在初治弥漫大B细胞淋巴瘤患者中的疗效和安全性 

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  • 安徽医科大学附属省立医院(合肥230001)

网络出版日期: 2023-04-25

基金资助

安徽省重点研究和开发计划项目(编号:1804h08020249) 

Comparing the efficacy and safety of rituximab with other biosimilars combined with CHOP regimen in the treatment of patients with newly diagnosed diffuse large B⁃cell lymphoma

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  • Provin⁃ cial Hospital Affiliated to Anhui Medical University,Hefei 230001,China

Online published: 2023-04-25

摘要

目的 比较利妥昔单抗原研药(美罗华® )及国产生物类似药(汉利康® ),联合 CHOP 方案初 治弥漫大 B 细胞淋巴瘤(DLBCL)的疗效和安全性。方法 将 R⁃CHOP 治疗的初治 DLBCL 分为 R 组(美罗 华®治疗组)(40 例)、H 组(汉利康®治疗组)(34 例)、R/H 组(美罗华®/汉利康®转换治疗组)(27 例)。收集 第 4 个疗程(C4)及化疗结束完全缓解率(CRR)、部分缓解率(PRR)、总体缓解率(ORR)、治疗结束后 2年 无进展生存(PFS)及总生存(OS),不良事件。结果 患者均接受随访。3组治疗中、末期CR、PR、ORR、2年 PFS、OS、不良事件差异无统计意义(P > 0.05)。结论 原研药利妥昔单抗(美罗华® )及国产生物类似药 (汉利康® )均可用于联合CHOP 方案治疗初治DLBCL 患者,两者的疗效和安全性相当。 

本文引用格式

范丹丹 胡茂贵 丁凯阳 曹琳琳 封媛媛 王翠翠 明静 宋浩 王馨辰 . 利妥昔单抗联合CHOP 方案治疗在初治弥漫大B细胞淋巴瘤患者中的疗效和安全性 [J]. 实用医学杂志, 2023 , 39(8) : 1022 -1028 . DOI: 10.3969/j.issn.1006⁃5725.2023.08.018

Abstract

Objective To analyze and compare the effect and safety of the rituximab researched drug (Rituxan® )and domestic biosimilar(Hanlikang® )combined with CHOP regimen in the treatment of patients with newly diagnosed diffuse large B⁃cell lymphoma(DLBCL). Methods The newly diagnosed DLBCL patients who received R⁃CHOP treatment were collected into our study and divided into 3 groups:R group(Rituxan® treatment group)(n = 40),H group(Hanlikang® treatment group)(n = 34),R/H group(Rituxan®/Hanlikang® treatment group)(n = 27). The main indicators were collected[complete remission rate(CR),partial remission rate(PR) were recorded at the 4th cycle(C4)and at the end of chemotherapy,and the overall response rate(overall response rate,ORR)]and secondary indicators[2 years after treatment,the progression free survival rate(PFS)and total survival(overall survival,OS),adverse events]were recorded and compared. Results The patients in the group R,group H and group R/H were followed upfor at least 2 years,the follow⁃up rates were 100.00%.There was no significant difference in CR,PR,ORR in the middle and end of treatment,2 year⁃PFS,2⁃year OS and adverse events within 3 groups(all P > 0.05). Conclusion Both the original research drug rituximab(Rituxan® )and the domestic biosimilar(Hanlikang® )can be used in combination with CHOP regimen in the treatment of newly diag⁃ nosed DLBCL patients,the efficacy and safety of both are comparable.

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