摘要目的:探讨程序性细胞死亡受体1(PD-1)单抗联合化疗在ⅢA期非小细胞肺癌(NSCLC)术前新辅助治疗中的有效性和安全性。方法:选取2019年1月至2020年10月期间在甘肃省肿瘤医院行术前新辅助治疗的ⅢA期NSCLC患者65例，其中男38例，女27例；<65岁者40例，≥65岁者25例。根据术前新辅助治疗方案不同分为对照组(31例)和观察组(34例)。对照组采用注射用白蛋白结合型紫杉醇+顺铂治疗，观察组在对照组基础上联合免疫治疗(卡瑞利珠单抗/信迪利单抗)，均行2周期术前新辅助治疗。比较两组影像学临床疗效、T淋巴细胞亚群、药物毒副反应、手术切除率、主要病理缓解(MPR)、完全病理缓解(pCR)和术后并发症，分析影响MPR的因素。结果:观察组影像学临床疗效部分缓解(PR)和客观缓解率(ORR)均优于对照组( P<0.05)。观察组治疗后CD3 +细胞阳性率、CD4 +细胞阳性率、CD8 +细胞阳性率和CD4 +/CD8 +细胞比值均高于对照组( P<0.05)。观察组药物毒副反应在皮肤反应性毛细血管增生症(RCCEP)/皮疹、甲状腺功能异常、心肌酶异常方面均高于对照组( P<0.05)。观察组(卡瑞利珠单抗组/信迪利单抗组)组内比较，卡瑞利珠单抗组毒副反应在RCCEP/皮疹、骨髓抑制、心肌酶异常方面均高于信迪利单抗组( P<0.05)。观察组的MPR和pCR均高于对照组( P<0.05)。两组在手术切除率、手术方式和术后并发症方面差异均无统计学意义( P>0.05)。单因素分析结果显示，ECOG评分、病理类型、新辅助治疗方案与MPR相关( P<0.05)。二元 logistic回归分析结果显示，ECOG评分和新辅助治疗方案是影响MPR的独立危险因素( P<0.05)。 结论:PD-1单抗联合化疗可获得更好的MPR和pCR，提升患者免疫功能。但免疫治疗药物引起的毒副反应值得关注，不同免疫药物之间毒副反应有所不同。

abstractsObjective:To study the effectiveness and safety of programmed cell death receptor 1(PD-1) monoclonal antibody combined with chemotherapy in the preoperative neoadjuvant treatment of stage ⅢA non-small cell lung cancer(NSCLC).Methods:A total of 65 patients with stage ⅢA NSCLC who underwent preoperative neoadjuvant treatment in our hospital from January 2019 to October 2020 were selected. According to the preoperative neoadjuvant treatment plan, they were divided into control group(31 cases) and observation group(34 cases). Patients in the control group were treated with albumin-bound paclitaxel and cisplatin for injection, and the patients in the observation group were treated with immunotherapy(carrelizumab/sintilizumab) on the basis of the control group, all underwent 2 cycles of preoperative neoadjuvant treatment. Compared the clinical efficacy of imaging, T lymphocyte subsets, drug side effects, surgical resection rate, major pathological remission(MPR), complete pathological remission(pCR) and postoperative complications of the two groups of patients, and analyzed the factors those affected MPR.Results:The clinical efficacy of PR and ORR of imaging in the observation group was better than that of the control group( P<0.05). The positive rate of CD3 + cells, the positive rate of CD4 + cells, the positive rate of CD8 + cells and the ratio of CD4 + /CD8 + cells in the observation group after treatment were higher than those in the control group( P<0.05). The drug toxicity of the observation group was higher than that of the control group in RCCEP/rash, abnormal thyroid function, and abnormal myocardial enzymes( P<0.05). Compared among the observation group(carrelizumab group/sintilizumab group), the toxicity of carrelizumab group was higher than that of sintilizumab group in RCCEP/skin rash, bone marrow suppression and abnormal myocardial enzymes( P<0.05). The MPR and pCR of the observation group were higher than those of the control group( P<0.05). There was no significant difference in surgical resection rate, surgical methods and postoperative complications between the two groups( P>0.05). The results of univariate analysis showed that ECOG score, pathological type, neoadjuvant treatment plan were related to MPR( P<0.05). The results of binary logistic regression analysis showed that ECOG score and neoadjuvant treatment plan were independent risk factors affecting MPR( P<0.05). Conclusion:PD-1 monoclonal antibody combined with chemotherapy can enable patients to obtain better MPR and pCR, and can improve the immune function of patients. But the side effects caused by immunotherapy drugs are worthy of attention, and the side effects are different between different immune drugs.