信迪利单抗联合DA-EPOCH-R方案治疗弥漫大B细胞淋巴瘤的效果及安全性评价  

Efficacy and safety evaluation of sintilimab combined with DA-EPOCH-R regimen in treatment of diffuse large B-cell lymphoma

作　　者：丁琪 陈婧 梁雪 DING Qi;CHEN Jing;LIANG Xue(Department of Hematology,Luoyang City Third People's Hospital,Luoyang 471002,China)

机构地区：[1]洛阳市第三人民医院血液科,河南洛阳471002

出　　处：《药物评价研究》2022年第11期2296-2302,共7页Drug Evaluation Research

摘　　要：目的评价信迪利单抗联合环磷酰胺^(+)表柔比星^(+)依托泊苷^(+)长春新碱^(+)泼尼松、利妥昔单抗无放射治疗(DA-EPOCH-R)方案治疗弥漫大B细胞淋巴瘤(DLBCL)的效果及安全性。方法回顾性选取2019年3月—2022年2月洛阳市第三人民医院收治的经一线治疗方案治疗后疾病复发或进展的DLBCL患者103例,根据治疗方案分为试验组54例、对照组49例。对照组给予DA-EPOCH-R方案治疗,试验组在对照组基础上加用信迪利单抗治疗。比较两组治疗前后免疫相关指标、血管内皮生长因子(VEGF)、血清胸苷激酶1(TK1)、白细胞介素-2(IL-2)水平,统计疗效和不良反应。结果试验组客观缓解率(ORR)达72.22%,高于对照组的53.06%,差异有统计学意义(P<0.05)。治疗后,试验组Treg细胞占比及VEGF、TK1水平低于本组治疗前(P<0.05),Th17细胞占比、IL-2水平高于本组治疗前(P<0.05);对照组NK细胞占比及VEGF、TK1水平低于本组治疗前(P<0.05),Treg细胞占比及IL-2水平高于本组治疗前(P<0.05);两组CD3^(+)T、CD3^(+)CD4^(+)T、CD3^(+)CD8^(+)T与治疗前比较无统计学意义(P>0.05)。试验组治疗后IL-2水平、NK细胞占比、Th17细胞占比较对照组更高(P<0.05),Treg细胞占比及VEGF、TK1水平较对照组更低(P<0.05)。试验组和对照组败血症、皮疹、肺部感染、黏膜炎、腹泻、恶心呕吐、脱发、肾功能损伤、肝功能损伤、血小板减少、白细胞减少、贫血、发热、甲状腺功能减退等不良反应方面比较,差异无统计学意义(P>0.05)。结论信迪利单抗联合DA-EPOCH-R方案治疗DLBCL可改善患者免疫功能,降低VEGF、TK1的表达,加强疗效,安全性良好。Objective To observe the efficacy and safety of sintilimab combined with dose-adjusted etoposide,doxorubicin and cyclophosphamide with vincristine,prednisone and rituximab without radiotherapy(DA-EPOCH-R)regimen in treatment of diffuse large B-cell lymphoma(DLBCL).Methods A total of 103 patients with DLBCL who relapsed or progressed after first-line treatment in Luoyang Third People's Hospital from March 2019—February 2022 were selected retrospectively.According to the treatment plan,they were divided into 54 cases in the experimental group and 49 cases in the control group.Patients in the control group were treated with DA-EPOCH-R regimen,and patients in the experimental group were treated with sintilimab on the basis of the control group.The immune related indexes,vascular endothelial growth factor(VEGF),serum thymidine kinase 1(TK1)and interleukin-2(IL-2)levels were compared between the two groups,statistical efficacy and adverse reactions were recorded.Results The objective remission rate(ORR)in the experimental group was 72.22%,which was higher than 53.06%in the control group(P<0.05).The percentage of Treg cells,levels of VEGF and TK1 in the experimental group were lower than those before treatment.The percentage of Th17 cells and IL-2 level were higher than those before treatment(P<0.05),and the percentage of NK cells,levels of VEGF and TK1 in the control group were lower than those before treatment(P<0.05),and the percentage of Treg cells and IL-2 level were higher than those before treatment(P<0.05),and CD3^(+)T,CD3^(+)CD4^(+)T and CD3^(+)CD8^(+)T in the two groups had no statistical significance compared with those before treatment(P>0.05).After treatment,IL-2 level,the percentage of NK cells and Th17 cells in the experimental group were higher than those in the control group (P < 0.05), and the percentage of Treg cells, levelsof VEGF and TK1 were lower than those in the control group (P < 0.05). There was no significant difference between theexperimental group and the control group in terms of sepsis,

关 键 词：信迪利单抗 DA-EPOCH-R方案 弥漫大B细胞淋巴瘤 免疫功能 血管内皮生长因子 

分 类 号：R979.1[医药卫生—药品]