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年美国FDA加速批准了Pola-BR用于治疗r/r DLBCL成                        notherapy  in  relapsed  or  refractory  diffuse  large  B-cell
          人患者。2022 年美国血液学学会公布的 GO29365 研究                         lymphoma:the  ORCHARRD  study[J].  J  Clin  Oncol,
          终期 5 年的随访分析结果显示,Pola-BR 方案可为 r/r                        2017,35(5):544-551.
                                                                                                ®
          DLBCL 患者带来 OS 持久获益,且无新增不良反应报                       [ 6 ]  Food and Drug Administration. GAZYVA(obinutuzumab)
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          道 。此外,除了Pola-BR方案,维泊妥珠单抗联合利妥                            injection,for intravenous infusion[EB/OL]. [2025-01-10].
          昔单抗、吉西他滨和奥沙利铂(Pola-R-GemOx)治疗 r/r                       https://www.accessdata.fda.gov/scripts/cder/daf/index.
                                                                  cfm.
          DLBCL 也具有良好疗效。一项Ⅲ期临床试验——
                                                             [ 7 ]  SEHN L H,MARTELLI M,TRNĚNÝ M,et al. A randomi-
          POLARGO 研究(NCT04182204)的初步结果表明,Pola-
                                                                  zed,open-label,Phase Ⅲ study of obinutuzumab or rituxi-
          R-GemOx 方案治疗 r/r DLBCL 患者的 ORR 和 CR 率分
                                                                  mab plus CHOP in patients with previously untreated dif‐
          别为40%、27%,血小板和中性粒细胞减少症是最常见的
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          AEs,但未发生5级或导致停药的AEs 。
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          4 结语
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              r/r DLBCL的治疗一直是临床面对的棘手问题。近
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          年来随着研究者在抗体药物结构上的创新,增强了其免                                Exp Hematol Oncol,2012,1(1):36.
          疫杀伤力和靶向细胞毒性。近年来已被批准上市的单                            [ 9 ]  DUELL  J,ABRISQUETA  P,ANDRE  M,et  al.  Ta‐
          抗药物坦昔妥单抗,双抗药物奥尼妥单抗、格菲妥单抗、                               fasitamab  for  patients  with  relapsed  or  refractory  diffuse
          艾可瑞妥单抗,ADC 药物维泊妥珠单抗、泰朗妥昔单抗                              large  B-cell  lymphoma:final  5-year  efficacy  and  safety
          等均对 r/r DLBCL 患者人群显示出较高的 ORR 和 CR                       findings  in  the  phase  Ⅱ  L-MIND  study[J].  Haemato‐
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          用中仍面临诸多挑战,如治疗安全性、患者耐受性等。                           [10]  BARCLAY A N,VAN DEN BERG T K. The interaction
          目前正在进行的多项大规模、多中心临床试验正在探索                                between  signal  regulatory  protein  alpha (SIRPα)  and
          这些药物的联合化疗方式、最佳使用剂量以及如何减少                                CD47:structure,function,and therapeutic target[J]. Annu
          治疗相关毒性,以提高患者的耐受性和长期生存率。综                                Rev Immunol,2014,32:25-50.
          上所述,抗体药物在r/r DLBCL治疗中展现出巨大潜力,                      [11]  MAAKARON  J,ASCH A  S,POPPLEWELL  L  L,et al.
          但仍需进一步研究和临床验证,以优化治疗策略,为患                                Magrolimab  in  combination  with  rituximab+chemo‐
          者带来更好的预后。                                               therapy in patients with relapsed or refractory (R/R) dif‐
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          中国药房  2025年第36卷第13期                                              China Pharmacy  2025 Vol. 36  No. 13    · 1681 ·
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