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信迪利单抗联合贝伐珠单抗用于晚期不可切除肝细胞癌患者

          TACE后的临床观察
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          魏 磊 ,刘 演 ,吴 焱 ,卫 武 ,强 铭(1.解放军联勤保障部队第九〇一医院肿瘤科,合肥 230031;
          2.中国科学院合肥肿瘤医院肿瘤科,合肥 230022;3.安徽医科大学附属第二医院肿瘤科,合肥 260301)
          中图分类号  R979.1;R735.7      文献标志码  A      文章编号  1001-0408(2024)24-3029-06
          DOI  10.6039/j.issn.1001-0408.2024.24.11

          摘  要  目的  观察信迪利单抗联合贝伐珠单抗用于晚期不可切除肝细胞癌(HCC)患者肝动脉化疗栓塞术(TACE)后的疗效、肿
          瘤标志物及免疫功能,以及用药后的安全性。方法  选取2022年6-12月于解放军联勤保障部队第九〇一医院就诊的120例晚期
          不可切除HCC患者,按随机数字表法分为对照组(n=60)和研究组(n=60)。两组患者均接受TACE,在此基础上,对照组患者给
          予甲苯磺酸索拉非尼片,研究组患者给予信迪利单抗注射液+贝伐珠单抗注射液。观察两组患者治疗3个月后的疗效、肿瘤标志
          物(甲胎蛋白、癌胚抗原、糖类抗原199)、免疫功能指标(CD3 、CD4 、CD8 、CD4 /CD8)水平及不良反应发生情况。结果  治疗后,
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          两组患者的客观缓解率、疾病控制率、死亡率、中位无进展时间比较,差异均无统计学意义(P>0.05),研究组患者的中位总生存时
          间显著长于对照组(P<0.05);两组患者的肿瘤标志物水平、免疫功能指标水平(除外CD8)均显著低于同组治疗前,且研究组的
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          肿瘤标志物水平均显著低于对照组,免疫功能指标水平(除外CD8)显著高于对照组(P<0.05)。两组患者3级不良反应发生率以
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          及甲状腺功能减退、免疫相关性肺炎等1~2级不良反应发生率比较,差异均无统计学意义(P>0.05)。结论  信迪利单抗联合贝伐
          珠单抗能有效改善晚期不可切除HCC患者经TACE后的免疫功能,提高总生存时间,降低肿瘤标志物水平,且安全性较好。
          关键词  肝细胞癌;晚期不可切除;信迪利单抗;贝伐珠单抗;肝动脉化疗栓塞术;疗效;免疫功能
          Clinical  observation  of  sintilimab  combined  with  bevacizumab  in  the  treatment  of  advanced  unresectable
          liver cancer after transcatheter arterial chemoembolization
          WEI Lei ,LIU Yan ,WU Yan ,WEI Wu ,QIANG Ming(1.  Dept.  of  Oncology,  No.  901  Hospital  of  Joint
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          Service  Support  Force  of  PLA,  Hefei  230031,  China;2.  Dept.  of  Oncology,  Hefei  Cancer  Hospital  of  Chinese
          Academy  of  Sciences,  Hefei  230022,  China;3.  Dept.  of  Oncology,  the  Second  Hospital  of  Anhui  Medical
          University, Hefei 260301, China)
          ABSTRACT   OBJECTIVE  To  observe  the  efficacy,  tumor  markers,  immune  function  and  safety  of  sintilimab  combined  with
          bevacizumab  in  the  treatment  of  advanced  unresectable  hepatocellular  carcinoma (HCC)  after  transcatheter  arterial  chemoembolization
         (TACE).  METHODS  A  total  of  120  patients  with  advanced  unresectable  HCC  in  No.901  Hospital  of  Joint  Service  Support  Force
          of  PLA  from  June  2022  to  December  2022  were  selected  and  divided  into  control  group (n=60)  and  study  group (n=60)  using
          the  random  number  method.  Both  groups  received  TACE.  The  control  group  was  treated  with  Sorafenib  mesylate  tablets,  and  the
          study  group  was  treated  with  Sintilimab  injection  combined  with  Bevacizumab  injection.  The  clinical  efficacy,  tumor  markers
         (alpha-fetoprotein, carcinoembryonic antigen, carbohydrate antigen 19-9), immune function indexes (CD3 , CD4 , CD8 , CD4 /
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          CD8 ),  and  adverse  reactions  of  the  two  groups  were  observed  after  three  months  of  treatment.  RESULTS  After  the  treatment,
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          there  was  no  significant  difference  between  the  two  groups  in  objective  remission  rate,  disease  control  rate,  mortality  rate,  or
          median  progression-free  survival (P>0.05).  The  median  overall  survival  of  the  study  group  was  significantly  longer  than  control
          group (P<0.05).  After  treatment,  the  levels  of  tumor  markers  and  immune  function (except  for  CD8 )  in  both  groups  were
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          significantly  lower  than  before  treatment;  the  average  levels  of  tumor  markers  in  the  study  group  were  significantly  lower  than
          control  group,  while  the  levels  of  immune  function (except  for  CD8 )  were  significantly  higher  than  control  group (P<0.05).
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          There was no statistically significant difference in the incidence of grade 3 adverse reactions, as well as the incidence of grade 1-2
          adverse reactions such as hypothyroidism and immune-related pneumonia between the two groups (P>0.05). CONCLUSIONS For
          advanced  unresectable  HCC  patients  undergoing  TACE,  bevacizumab  combined  with  sintilimab  can  effectively  improve  immune
          function, reduce tumor markers and improve the overall survival with good safety.
                                                             KEYWORDS     hepatocellular  carcinoma;  advanced  unresectable;
             Δ 基金项目 安徽省自然科学基金项目(No.AHWJ2021b007)
             *第一作者 副主任医师。研究方向:常见恶性肿瘤的综合治疗。                   sintilimab;  bevacizumab;  transcatheter  arterial  chemoemboli-
          E-mail:weileixxxwl@sina.com                        zation; efficacy; immune function


          中国药房  2024年第35卷第24期                                              China Pharmacy  2024 Vol. 35  No. 24    · 3029 ·
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