中国临床药理学杂志2025，Vol.41Issue(18)：2599-2604,6.DOI:10.13699/j.cnki.1001-6821.2025.18.005
泽布替尼联合来那度胺及利妥昔单抗治疗难治或复发性弥漫大B细胞淋巴瘤的临床研究
Clinical study of zanubrutinib combined with lenalidomide and rituximab in the treatment of refractory or relapsed diffuse large B-cell lymphoma
摘要
Abstract
Objective To investigate the efficacy and safety of zanubrutinib capsules-rituximab injection-lenalidomide capsules(ZR2)in the treatment of relapsed/refractory(R/R)diffuse large B-cell lymphoma(DLBCL).Method Patients with R/R DLBCL were divided into control group and treatment group according to a random number table.The control group received rituximab injection 375 mg·m-2 by intravenous infusion on day 1 of the treatment cycle,and orally took lenalidomide capsules 25 mg once daily from day 1 to day 14 of the cycle.The treatment group received oral zanubrutinib capsule 160 mg twice daily from day 1 to day 21 of the cycle,in addition to the treatment given to the control group.Both groups were treated in 21-day cycles for a total of 6 cycles.The clinical efficacy,immune environment-related indicators,inflammation-related indicators,angiogenesis and metabolism-related indicators,rogression-free survival(PFS)and overall survival(OS)were compared between the two groups.Results In control group,2 cases were lost to follow-up and 1 case withdrew,resulting in 40 cases actually included;in treatment group,3 cases were lost to follow-up,resulting in 40 cases actually included.After treatment,the disease control rates(DCR)of the control group and the treatment group were 60.00％and 82.50％,respectively;cluster of differentiation 3 positive T lymphocyte(CD3+)were(62.17±8.23)％and(67.29±7.95)％,respectively;cluster of differentiation 4 positive T lymphocyte(CD4+)/cluster of differentiation 8 positive T lymphocyte(CD8+)were 1.44±0.36 and 1.65±0.47,respectively;T helper 17 cell(Th17)were(1.37±0.34)％and(1.62±0.46)％,respectively;natural killer cell(NK)were(22.47±3.69)％and(24.86±4.12)％,respectively;tumor necrosis factor-alpha(TNF-α)were(23.35±6.28)and(19.62±5.31)pg·mL-1,respectively;soluble interleukin-2 receptor(sIL-2r)were(621.74±134.89)and(539.48±116.83)U·mL-1,respectively;lactate dehydrogenase(LDH)were(278.64±56.84)and(251.37±48.43)U·L-1,respectively;beta-2-microglobulin(β2-MG)were(1.86±0.87)and(1.49±0.74)mg·L-1,respectively;the PFS rates were 22.50％and 52.50％,respectively;the OS rates were 45.00％and 67.50％,respectively.The differences in the above data between the two groups of patients were statistically significant(all P＜0.05).The total incidence of adverse drug reactions in the control group and the experimental group were 67.50％(27 cases/40 cases)and 77.50％(31 cases/40 cases)respectively,with no statistically significant difference,(P＞0.05).Conclusion ZR2 regimen can improve the tumor immune microenvironment,suppress inflammatory responses and tumor angiogenesis in patients with R/R DLBCL,thereby leadingto higher DCR and improved long-term survival benefits,without increasing the risk of treatment-related adverse events.关键词
泽布替尼胶囊/来那度胺胶囊/利妥昔单抗注射液/弥漫大B细胞淋巴瘤/免疫功能Key words
zanubrutinib capsules/lenalidomide capsules/rituximab injection/diffuse large B-cell lymphoma/immune function分类
临床医学引用本文复制引用
赵芳,李淑晨,刘敬敬,尹凤雷,刘静,杨博,王娟..泽布替尼联合来那度胺及利妥昔单抗治疗难治或复发性弥漫大B细胞淋巴瘤的临床研究[J].中国临床药理学杂志,2025,41(18):2599-2604,6.基金项目
2024年度河北省卫生健康委医学科学研究基金资助项目(20240681) （20240681）
