目的 探讨参一胶囊联合纳武利尤单抗注射液治疗晚期胃癌的临床疗效。方法 选取2023年4月—2025年11月徐州医科大学附属医院收治的晚期胃癌患者共86例，按照随机数字表法将患者分为对照组和治疗组，各43例。对照组静脉滴注纳武利尤单抗注射液3 mg/kg，1次/2周。治疗组在对照组基础上口服参一胶囊，2粒/次，2次/d。两组患者持续治疗8周。比较两组的治疗效果、体能状况、血清肿瘤标志物和外周血T淋巴细胞亚群指标。结果 治疗后，对照组和治疗组的客观缓解率分别为51.16%、62.79%，组间比较有明显差异（P＜0.05）。两组治疗后的东部肿瘤协作组体能状况评分标准（ECOG）评分显著降低（P＜0.05），且治疗组ECOG评分明显低于对照组（P＜0.05）。两组治疗后的血清糖类抗原72-4（CA724）、糖类抗原19-9（CA199）、神经元特异性烯醇化酶（NSE）水平均显著降低（P＜0.05），治疗组的血清CA724、CA199、NSE水平均明显低于对照组（P＜0.05）。两组治疗后的Treg、CD8⁺CD28^-明显降低，CD8⁺CD28⁺明显升高（P＜0.05）；治疗组治疗后的Treg、CD8⁺CD28^-明显低于对照组，CD8⁺CD28⁺明显高于对照组（P＜0.05）。结论 参一胶囊联合纳武利尤单抗注射液可提高晚期胃癌患者的疾病控制率，提高患者体能状况，降低肿瘤标志物水平，改善免疫功能。

Objective To investigate the clinical efficacy of Shenyi Capsules combined with Nivolumab Injection in treatment of advanced gastric cancer. Methods A total of 86 patients with advanced gastric cancer admitted to Affiliated Hospital of Xuzhou Medical University from April 2023 to November 2025 were selected and divided into control group and treatment group according to the random number table method, with 43 cases in each group. The control group received intravenous infusion of Nivolumab Injection at 3 mg/kg every 2 weeks. The treatment group was additionally administered oral Shenyi Capsules on top of the control group regimen, at 2 tablets per dose, twice daily. Two groups underwent continuous treatment for 8 weeks. The treatment effects, physical condition, serum tumor markers, and peripheral blood T lymphocyte subsets were compared between two groups. Results After treatment, the objective remission rates of the control group and the treatment group were 51.16% and 62.79%, respectively, with significant differences between two groups (P < 0.05). After treatment, the ECOG scores were significantly reduced in two groups (P < 0.05), and the ECOG scores of the treatment group were significantly lower than those of the control group (P < 0.05). After treatment, the serum levels of carbohydrate antigen 72-4 (CA724), carbohydrate antigen 19-9 (CA199), and neuron specific enolase (NSE) in two groups were significantly reduced (P < 0.05). The serum levels of CA724, CA199, and NSE in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, Treg and CD8⁺CD28^- levels were significantly reduced in two groups, while CD8⁺CD28⁺ levels were significantly increased (P < 0.05). The Treg and CD8⁺CD28^- levels in the treatment group were significantly lower than those in the control group, while CD8⁺CD28⁺ levels were significantly higher than those in the control group (P < 0.05). Conclusion The combination of Shenyi Capsules and Nivolumab Injection can improve the disease control rate of advanced gastric cancer patients, enhance their physical condition, reduce tumor marker levels, and improve immune function.

R975;R979.1