纳武利尤单抗联合伊匹木单抗治疗晚期胃癌患者的临床评价  

Clinical evaluation of nivolumab and ipilimumab in treatment of patients with advanced gastric cancer

作　　者：顾丽磊 周昱岐 沈红石 薛莲 吴亚亭 Gu Li-lei;Zhou Yu-qi;Shen Hong-shi;Xue Lian;Wu Ya-ting(Department of Hematologic Oncology,The 904th Hospital of the Joint Logistics Support Force of Chinese People’s Liberation Army,Wuxi 214000,China)

机构地区：[1]中国人民解放军联勤保障部队第九〇四医院血液肿瘤科,无锡214000

出　　处：《中国药物应用与监测》2025年第2期244-247,共4页Chinese Journal of Drug Application and Monitoring

基　　金：江苏省卫生健康委科研项目(M2021090)。

摘　　要：目的纳武利尤单抗联合伊匹木单抗治疗晚期胃癌的临床评价。方法纳入中国人民解放军联勤保障部队第九〇四医院2022年6月至2024年6月治疗的晚期胃癌患者共94例为此次试验对象,计算机生成随机数字表法分成两组。对照组47例患者给予纳武利尤单抗治疗,研究组47例患者给予纳武利尤单抗联合伊匹木单抗治疗。统计两组完全缓解、部分缓解、疾病稳定和疾病进展患者并比较客观缓解率。比较两组患者血清肿瘤标志物癌胚抗原、糖类抗原19-9和T淋巴细胞亚群CD4+、CD8+和CD4+、CD8+百分比以及发生不良反应情况。结果治疗后研究组的客观缓解率为53.19%(25/47),高于对照组的27.66%(13/47)(χ^(2)=6.361,P=0.012);治疗后,两组的癌胚抗原和糖类抗原19-9水平均较治疗前降低,且研究组水平[(5.17±1.23)ng·mL^(-1)、(25.74±3.12)U·mL^(-1)]低于对照组[(6.28±1.36)ng·mL^(-1)、(28.41±3.68)U·mL^(-1)],差异有统计学意义(t=4.150,3.794,均P<0.05)。CD4+和CD4+/CD8+水平,治疗后,两组的均较治疗前出现上升情况,且研究组水平[(45.86±3.85)%、(1.59±0.23)]高于对照组[(41.78±3.33)%、(1.38±0.21)],差异有统计学意义(t=5.495,4.623,均P<0.05)。CD8+水平,治疗后两组均出现下降情况,且研究组水平[(28.84±3.13)%]低于对照组[(30.27±3.38)%],差异有统计学意义(t=2.128,P=0.036)。不良反应总发生率研究组为78.72%(37/47),对照组为70.21%(33/47),组间比较差异无统计学意义(χ^(2)=1.229,P=0.268)。结论纳武利尤单抗联合伊匹木单抗治疗晚期胃癌具有较高的疗效,能够降低患者血清肿瘤相关标志物CEA和CA19-9水平,改善T淋巴细胞亚群分布,并且安全性高。Objective To investigate the therapeutic efficacy of nivolumab combined with ipilimumab in the treatment of multiple advanced gastric cancer.Methods Ninety-four patients with advanced gastric cancer admitted to The 904th Hospital of the Joint Logistics Support Force of Chinese People’s Liberation Army between June 2022 and June 2024 were recruited for this study.These patients were randomly divided into a control group(n=47)and a study group(n=47)utilizing the random number table method.The patients in the control group were treated with nivolumab,and those in the study group with nivolumab and ipilimumab.The number of patients with complete response(CR),partial response(PR),stable disease(SD),and progressive disease(PD)was counted and objective sustained release rate(ORR)was calculated.Serum tumor marker carcinoembryonic antigen(CEA)and carbohydrate antigen 19-9(CA19-9)levels,CD4+ratio,CD8+ratio and CD4+/CD8+levels were detected and adverse reactions occurred during treatment were recorded.Results After treatment,the ORR of the study group was 53.19%(25/47),which was significantly higher than that of the control group(27.66%,13/47)(χ^(2)=6.361,P=0.012).Both groups showed reduced levels of CEA and CA19-9 as compared with the baseline,with the study group demonstrating lower levels((5.17±1.23)ng·mL^(-1),(25.74±3.12)U·mL^(-1))than the control((6.28±1.36)ng·mL^(-1),(28.41±3.68)U·mL^(-1)),and the differences were statistically significant(t=4.150,3.794,both P<0.05).Additionally,CD4+and CD4+/CD8+ratios were increased in both groups after treatment,with the study group exhibiting higher values((45.86±3.85)%,(1.59±0.23))than the control((41.78±3.33)%,(1.38±0.21)),and the differences were statistically significant(t=5.495,4.623,both P<0.05).Conversely,CD8+levels were decreased in both groups,with the study group showing lower values((28.84±3.13)%)than the control((30.27±3.38)%),and the difference was statistically significant(t=2.128,P=0.036).Regarding total adverse reaction rate,the study group had 78.7

关 键 词：纳武利尤单抗 伊匹木单抗 晚期胃癌 癌胚抗原 糖类抗原19-9 T淋巴细胞亚群 

分 类 号：R73[医药卫生—肿瘤]