目的 探讨抗生素（ATB）及质子泵抑制剂（PPI）对免疫检查点抑制剂（ICI）治疗疗效的影响。方法 选取2020年12月至2022年11月于甘肃省肿瘤医院进行ICI治疗的晚期实体肿瘤患者为研究对象，通过电子病历收集相关临床信息，采用Kaplan-Meier生存曲线分析抗生素、PPI使用对患者总生存期（OS）及无进展生存期（PFS）的影响，通过Cox单因素和多因素比例风险模型分析患者预后的影响因素。结果 未使用抗生素（Non-ATB）组患者的中位PFS及中位OS明显优于使用抗生素（ATB）组，ATB的使用与接受ICI治疗的晚期实体恶性肿瘤患者的PFS及OS显著相关，ATB的使用是影响接受ICI治疗的晚期实体恶性肿瘤患者PFS及OS的独立预后因素。未使用PPI（Non-PPI）组患者的中位PFS及中位OS明显优于使用PPI（PPI）组，PPI的使用与接受ICI治疗的晚期实体恶性肿瘤患者PFS及OS显著相关，PPI的使用是影响接受ICI治疗的晚期实体恶性肿瘤患者OS的独立预后因素。未合并使用ATB或（和） PPI患者的中位PFS及中位OS明显优于合并使用ATB或（和） PPI组，合并使用ATB或（和） PPI与接受ICI治疗的晚期实体恶性肿瘤患者的PFS及OS显著相关，合并使用ATB或（和） PPI是影响接受ICI治疗的晚期实体恶性肿瘤患者PFS及OS的独立预后因素。结论 在晚期实体肿瘤患者中，ATB及PPI的使用可能会降低ICI治疗的疗效。

Objective To investigate the effect of antibiotics (ATB) and proton pump inhibitors (PPI) on the efficacy of immune checkpoint inhibitor therapy. Methods Patients with advanced solid tumors who underwent immune checkpoint inhibitor therapy in Gansu Provincial Cancer Hospital from December 2020 to November 2022 were selected as the study subjects, and relevant clinical information was collected through electronic medical records. The Kaplan-Meier survival curve was used to analyze the impact of ATB and PPI use on overall survival (OS) and progression-free survival (PFS). The Cox univariate and multivariate proportional hazards models were used to analyze the influencing factors of patient prognosis. Results The median PFS and median OS of patients in the non-ATB group were significantly better than those in the ATB group, and the use of ATB was significantly correlated with PFS and OS in patients with advanced solid malignancies treated with ICI, and the use of ATB was an independent prognostic factor affecting PFS and OS in patients with advanced solid malignancies treated with ICI. The median PFS and median OS of patients in the non-PPI group were significantly better than those in the PPI group, and the use of PPI was significantly correlated with PFS and OS in patients with advanced solid malignancies treated with ICI, and the use of PPI was an independent prognostic factor affecting the OS of patients with advanced solid malignancies treated with ICI. The median PFS and median OS of patients without concomitant ATB and/or PPI were significantly better than those in the concomitant ATB and/or PPI group, and the concomitant ATB or/or PPI was significantly associated with PFS and OS in patients with advanced solid malignancies treated with ICI, and the concomitant use of ATB and/or PPI was an independent prognostic factor affecting PFS and OS in patients with advanced solid malignancies treated with ICI. Conclusion The use of antibiotics and proton pump inhibitors may reduce the efficacy of ICI in patients with advanced solid tumors.

R969

兰州市科学技术局兰州市科技发展指导性计划项目（2022-5-108）； 甘肃省药品监督管理局药品监管科学研究项目（2025GSMPA078）