目的 观察采用芪珍胶囊联合甲磺酸阿帕替尼片治疗二线及以上治疗失败晚期胃癌的临床疗效。方法 选取2021年8月—2023年5月在陕西省核工业二一五医院收治的96例二线及以上治疗失败晚期胃癌患者，按照随机数字表法将患者分为对照组（48例）和治疗组（48例）。对照组早餐后0.5 h口服甲磺酸阿帕替尼片，0.5 g/次，1次/d。治疗组在对照组的基础上口服芪珍胶囊，5粒/次，3次/d。4周为1个疗程，两组治疗6个疗程后进行评价。。对比两组临床疗效、肿瘤标志物、细胞免疫功能指标。患者出院后开始随访1年，观察两组的无进展生存时间（PFS）、总生存时间（OS）。结果 治疗组的客观缓解率（ORR）、疾病控制率（DCR）高于对照组（P＜0.05）。治疗后，两组血清癌胚抗原（CEA）、糖类抗原199（CA199）、糖类抗原125（CA125）水平下降（P＜0.05），治疗组血清CEA、CA199、CA125水平低于对照组（P＜0.05）。治疗后，两组CD8⁺下降，CD3⁺、CD4⁺、CD4⁺/CD8⁺升高（P＜0.05），治疗组患者CD8⁺低于对照组，CD3⁺、CD4⁺、CD4⁺/CD8⁺高于对照组（P＜0.05）。治疗组的无进展生存时间（PFS）、总生存时间（OS）分别为6.5、10.0个月，均高于对照组的PFS和OS（4.3、5.7个月，P＜0.05）。结论 二线及以上治疗失败晚期胃癌采用芪珍胶囊联合甲磺酸阿帕替尼片治疗后，可控制疾病进展，降低肿瘤标志物水平，提高患者的免疫功能，延长患者的生存期。

Objective To observe the clinical efficacy of Qizhen Capsules combine with Apatinib Mesylate Tablets in treatment of second-line and above treatment failure advanced gastric cancer. Methods 96 Patients with advanced gastric cancer who failed in second-line and above treatment in No.215 Hospital of Shaanxi Nuclear Industry from August 2021 to May 2023 were divided into control group (48 cases) and study group (48 cases) by random number table method. Patients in the control group took orally Apatinib Mesylate Tablets half an hour after breakfast, 0.5 g/time, once daily. Patients in the treatment group were po administered with Qizhen Capsules on the basis of the control group, 5 capsules/time, 3 times daily. Four weeks was one course of treatment, and two groups of patients were evaluated after six courses of treatment. The clinical efficacy, tumor markers, and cellular immune function indicators were compared between two groups. The patients were followed up for 1 year after discharge, and the tumor progression-free survival time (PFS) and overall survival time (OS) in two groups were observed. Results The ORR and DCR of the treatment group were higher than those of the control group (P < 0.05). After treatment, the serum levels of CEA, CA199, and CA125 decreased in both groups (P < 0.05), and the serum levels of tumor markers in the treatment group were lower than those in the control group (P < 0.05). After treatment, CD8⁺ decreased in both groups, while CD3⁺, CD4⁺, and CD4⁺/CD8⁺ increased (P < 0.05). CD8⁺ in the treatment group was lower than that in the control group, while CD3⁺, CD4⁺, and CD4⁺/CD8⁺ were higher than those in the control group (P < 0.05). PFS and OS of the treatment group were 6.5 and 10.0 months, respectively, which were higher than the PFS and OS of the control group of 4.3 and 5.7 months (P < 0.05). Conclusion The combination of Qizhen Capsules and Apatinib Mesylate Tablets in treatment of advanced gastric cancer with second-line or higher treatment failure can control disease progression, reduce tumor marker levels, improve patient immune function, and prolong patient survival.

R979.1

陕西省科技计划项目(2021JQ-539)