目的 分析信迪利单抗联合紫杉醇(白蛋白结合型)、奈达铂(TN化疗方案)方案治疗非小细胞肺癌(NSCLC)晚期患者的疗效及对血清肿瘤标志物和免疫细胞水平的影响.方法 将患者随机分为对照组(第1天静脉注射80 mg·m-2奈达铂+260 mg·m-2紫杉醇)和试验组(在对照组基础上静脉滴注信迪利单抗200 mg).2组均21 d为1个周期,治疗4个周期.比较2组患者抗肿瘤疗效、肿瘤标志物、肺功能、免疫细胞因子及药物不良反应发生情况,统计2组1年生存情况.结果 治疗期间共脱落7例.最终试验组和对照组分别有98和96例患者纳入分析.治疗后,试验组和对照组的客观缓解率(ORR)分别为43.88％(43例/98例)和29.17％(28例/96例),疾病控制率(DCR)分别为77.55％(76例/98例)和60.42％(58例/96例),在统计学上差异有统计学意义(P＜0.05).治疗后,试验组和对照组的糖类抗原125(CA125)分别为(39.03±5.97)和(42.15±6.35)U·mL-1,鳞状细胞癌抗原(SCCA)分别为(4.58±0.63)和(5.29±0.84)ng·mL-1,用力肺活量(FVC)分别为(2.96±0.52)和(2.71±0.49)L,第 1 秒用力呼气容积(FEV1)/FVC 分别为(68.47±11.39)％和(64.92±10.43)％,Th1/Th2 分别为 5.01±0.63 和 5.36±0.74,Th17/Treg 分别为 1.04±0.15 和 1.20±0.19,CD4+/CD8+分别为 1.36±0.19 和 1.23±0.17,在统计学上差异均有统计学意义(均P＜0.05).试验组和对照组总药物不良反应发生率分别为25.51％(25例/98例)和22.92％(22例/96例),在统计学上差异无统计学意义(P＞0.05).2组1年总存活曲线比较,在统计学上差异无统计学意义(P＞0.05).结论 信迪利单抗联合TN化疗方案治疗晚期NSCLC可增强抗肿瘤疗效,降低肿瘤标志物水平,改善肺功能及免疫功能,且安全性良好.
Objective To analyze the efficacy of sintilizumab combined with paclitaxel(albumin-bound)and nedaplatin(TN chemotherapy regimen)in patients with advanced non-small cell lung cancer(NSCLC)and its effects on serum tumor markers and immune cell levels.Methods The patients were divided into control group and treatment group according to random number table method.In the control group,80 mg·m-2 nedaplatin and 260 mg·m-2 paclitaxel(albumin-bound type)were injected intravenally on the 1st day for 21 days.The etreatment group was given sindilizumab 200 mg intravenously on the basis of the control group,21 days a cycle for 4 cycles.The anti-tumor efficacy,tumor markers,lung function,immune cytokines and adverse drug reactions of the two groups were compared after 4 cycles of treatment,and the 1-year survival of the two groups was statistically analyzed.Results A total of 7 cases fell off during treatment.Finally,98 patients in the treatment group and 96 patients in the control group were included in the analysis.After treatment,the objective response rate(ORR)of treatment group and control group were 43.88％(43 cases/98 cases)and 29.17％(28 cases/96 cases);the disease control rate(DCR)were 77.55％(76 cases/98 cases)and 60.42％(58 cases/96 cases),the difference was statistically significant(all P＜0.05).After treatment,carbohydrate antigen 125(CA125)in treatment group and control group were(39.03±5.97)and(42.15±6.35)U·mL-1;squamous cell carcinoma antigen(SCCA)were(4.58±0.63)and(5.29±0.84)ng·mL-1;forced vital capacity(FVC)were(2.96±0.52)and(2.71±0.49)L;forced expiratory volume in the first second(FEV1)/FVC were(68.47±11.39)％and(64.92±10.43)％;Th1/Th2 were 5.01±0.63 and 5.36±0.74;Th17/Treg were 1.04±0.15 and 1.20±0.19;CD4+/CD8+were 1.36±0.19 and 1.23±0.17,respectively.The differences were statistically significant(all P＜0.05).The total incidence of adverse drug reactions in treatment group and control group were 25.51％(25 cases/98 cases)and 22.92％(22 cases/96 cases),respectively,the difference was not statistically significant(P＞0.05).There was no significant difference in 1-year overall survival curves between the two groups(P＞0.05).Conclusion Sindilizumab combined with TN chemotherapy regimen in the treatment of advanced NSCLC can enhance the anti-tumor efficacy,reduce the level of tumor markers,improve lung function and immune function,and has good safety.
刘丹;张海涛;林欢;王春
南京医科大学附属脑科医院、南京市胸科医院呼吸科,江苏南京 210029
药学
非小细胞肺癌;信迪利单抗;紫杉醇(白蛋白结合型);奈达铂
non-small cell lung cancer;sindillimab;albumin binding paclitaxel;nedaplatin
《中国临床药理学杂志》 2024 (005)
640-644 / 5
江苏省自然科学基金资助项目(BK20211256)
10.13699/j.cnki.1001-6821.2024.05.002
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