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信迪利单抗联合奥沙利铂与卡培他滨化疗方案用于进展期胃癌的效果

Efficacy of sintilimab combined with oxaliplatin and capecitabine(XELOX)chemotherapy regimen in the adjuvant treatment of advanced gastric cancer
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摘要 目的观察信迪利单抗联合奥沙利铂与卡培他滨用于进展期胃癌的效果。方法选取2021年1月—2024年12月宁德师范学院附属宁德市医院收治的进展期胃癌患者108例,按照随机数字表法分为抗PD-1联合治疗组和单纯化疗方案组,每组54例。单纯化疗方案组予奥沙利铂+卡培他滨治疗,抗PD-1联合治疗组在单纯化疗方案组基础上联合信迪利单抗治疗,2组均以21 d为1个疗程,持续治疗6个月。比较2组近期疗效,治疗前后肿瘤标志物[甲胎蛋白(AFP)、糖类抗原19-9(CA19-9)、癌胚抗原(CEA)]、T淋巴细胞(CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))、血管内皮功能指标[血管内皮生长因子-A(VEGF-A)、血管内皮生长因子-D(VEGF-D)、血管内皮生长因子受体-1(VEGFR-1)]水平变化,以及不良反应。结果抗PD-1联合治疗组治疗客观缓解率(ORR)与疾病控制率(DCR)分别为88.89%和96.30%,均高于单纯化疗方案组的70.37%和83.33%,差异均有统计学意义(χ^(2)_(ORR)=5.708,P=0.017;χ^(2)_(DCR)=4.960,P=0.026);治疗4个疗程后,2组AFP、CA19-9、CEA及VEGF-A、VEGFR-1水平均较治疗前降低,CD8^(+)水平较治疗前降低,而CD4^(+)、CD4^(+)/CD8^(+)及VEGF-D水平均较治疗前升高,且抗PD-1联合治疗组上述指标变化程度均大于单纯化疗方案组(P<0.01);抗PD-1联合治疗组与单纯化疗方案组不良反应总发生率(7.41%vs.11.11%)比较差异无统计学意义(χ^(2)=0.441,P=0.507)。结论信迪利单抗联合奥沙利铂与卡培他滨化疗方案可有效治疗进展期胃癌,降低肿瘤标志物水平,改善T淋巴细胞亚群及血管内皮功能,且安全性较高。 Objective To evaluate the efficacy of sintilimab combined with oxaliplatin and capecitabine(XELOX)in the adjuvant treatment of advanced gastric cancer.Methods A total of 108 patients with advanced gastric cancer admitted to Ningde Municipal Hospital of Ningde Normal University from January 2021 to December 2024 were selected and randomly divided into an anti-PD-1 combination therapy group and a chemotherapy-alone regimen group using a random number table,with 54 cases in each group.The chemotherapy-alone regimen group received oxaliplatin+capecitabine(XELOX)chemotherapy.The anti-PD-1 combination therapy group was treated with sintilimab in addition to the XELOX regimen.Both groups received a 21-day course of treatment,continues for 6 months.The short-term efficacy and the incidence of adverse reactions,furthermore,the changes in the levels of tumor markers(AFP,CEA,CA19-9),Tlymphocyte subsets(CD4^(+),CD8^(+),CD4^(+)/CD8^(+)),and vascular endothelial function indicators(VEGF-A,VEGF-D,VEGFR-1)were assessed before and after treatment were compared between the two groups.Results In the anti-PD-1 combination therapy group,the objective response rate(ORR)and disease control rate(DCR)were 88.89%and 96.30%,respectively,both of which were significantly higher than those in the chemotherapy-alone regimen group(70.37%and 83.33%),with statistically significant differences(χ^(2)_(ORR)=5.708,P=0.017;χ^(2)_(DCR)=4.960,P=0.026).Four cycles after treatment,the levels of AFP,CA19-9,CEA,VEGFA,and VEGFR-1 in both groups decreased compared to pretreatment levels.The CD8^(+)level also decreased,while the levels of CD4^(+),CD4^(+)/CD8^(+),and VEGF-D increased compared to pretreatment.Furthermore,the extent of change in all aforementioned indices was greater in the anti-PD-1 combination therapy group than in the chemotherapy-alone regimen group(P<0.01).The overall incidence of adverse reactions showed no statistically significant difference between the anti-PD-1 combination therapy group(7.41%)and the chemotherapy-alone regimen group(11.11%)(χ^(2)=0.441,P=0.507).Conclusion The combination of Sintilimab and oxaliplatin+capecitabine(XELOX)chemotherapy regimen is effective for the treatment of advanced gastric cancer.This combination can effectively reduce the levels of tumor markers,improve Tlymphocyte subsets and vascular endothelial function indicators,and exhibits high safety.
作者 林欣 郑款恒 阮召杰 LIN Xin;ZHENG Kuanheng;RUAN Zhaojie(Ningde Municipal Hospital of Ningde Normal University,Fujian Province,Ningde 352100,China)
出处 《临床合理用药》 2025年第36期16-20,共5页 Chinese Journal of Clinical Rational Drug Use
基金 医校融合发展专项(一般项目)(2024ZX90)。
关键词 进展期胃癌 信迪利单抗 奥沙利铂 卡培他滨 肿瘤标志物 T淋巴细胞亚群 血管内皮生长因子 Advanced gastric cancer Sintilimab Oxaliplatin Capecitabine Tumor markers Tlymphocyte subsets Vascular endothelial growth factor
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