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。
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.
作者
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
FAN Dandan;HU Maogui;DING Kaiyang;CAO Linlin;FENG Yuanyuan;WANG Cuicui;MING Jing;SONG Hao;WANG Xinchen(Provin-cial Hospital Affiliated to Anhui Medical University,Hefei 230001,China)
出处
《实用医学杂志》
CAS
北大核心
2023年第8期1022-1028,共7页
The Journal of Practical Medicine
基金
安徽省重点研究和开发计划项目(编号:1804h08020249)。
