信迪利单抗注射液联合化疗治疗复发或转移NSCLC患者疗效观察  

Efficacy observation of sintilimab injection combined with chemotherapy in the treatment of patients with recurrent or metastatic NSCLC

作　　者：章左林 童舟[2] 徐金发[1] ZHANG Zuo-lin;TONG Zhou;XU Jin-fa(Gynecological Papillary neck Tumor Department,Chizhou People's Hospital,Chizhou Anhui 247000,China;Department of Oncology,Chizhou People's Hospital,Chizhou Anhui 247000,China)

机构地区：[1]池州市人民医院妇乳头颈肿瘤病区,安徽池州247000 [2]池州市人民医院肿瘤科,安徽池州247000

出　　处：《临床和实验医学杂志》2023年第13期1374-1378,共5页Journal of Clinical and Experimental Medicine

基　　金：安徽省自然科学基金(编号:1908085QA27)。

摘　　要：目的 探讨信迪利单抗注射液联合化疗治疗复发或转移非小细胞肺癌(NSCLC)患者的临床疗效。方法 选取2020年1月至2021年3月池州市人民医院收治的60例NSCLC患者进行前瞻性研究。按照随机数字表法将患者分为对照组和观察组,每组各30例,对照组采用注射用紫杉醇260 mg/m2,分别于治疗第1天和第8天注射紫杉醇,观察组在其基础上予信迪利单抗注射液200 mg加入0.9%氯化钠注射液100 mL中静脉滴注,3周使用1次。21 d为1个疗程,均连续治疗3个疗程。评估两种方法的临床疗效以及分析两组患者的生存率、KPS评分及不良反应发生率。结果 观察组总有效率为53.3%,疾病控制率为86.7%,均高于对照组(20.0%、46.7%),差异均有统计学意义(P<0.05)。治疗结束、治疗后3、6个月,观察组KPS评分分别为(87.6±5.7)、(85.5±4.3)、(85.8±5.2)分,均明显高于对照组[(86.3±5.4)、(78.5±4.1)、(79.7±5.4)分],差异均有统计学意义(P<0.05)。截至随访终点,对照组中位无进展生存期(PFS)为4.00个月(95%CI:1.65~6.35),中位总生存时间(OS)为8.00个月(95%CI:6.85~9.15);观察组中位PFS为5.00个月(95%CI:2.06~7.94),中位OS为10.00个月(95%CI:8.90~11.10)。观察组的中位PFS、OS均高于对照组,两组患者生存曲线面积比较,差异有统计学意义(P<0.05)。结论 信迪利单抗注射液联合注射用紫杉醇(白蛋白结合型)治疗复发或转移晚期NSCLC患者临床疗效显著,能延长患者PFS和OS,且患者耐受性良好。Objective To investigate the clinical efficacy of cindilizmab injection combined with chemotherapy in patients with recurrent or metastatic NSCLC.Methods From January 2020 to March 2021,60 NSCLC patients admitted to Chizhou People's Hospital were selected for prospective cohort study.According to the random number table method,patients were divided into a control group and an observation group,with 30 cases in each group.The control group was treated with paclitaxel injection(albumin binding type),and the observation group was treated with Sintilimab injection on the basis of paclitaxel injection.Both groups were treated continuously for 3 courses of treatment.The clinical efficacy of both methods were evaluate and the survival rate,KPS score and incidence of adverse effects of both groups were analyzed.Results The total effective rate of the observation group was 53.3%,and the disease control rate was 86.7%,both higher than the control group(20.0%,46.7%),the differences were statistically significant(P<0.05).At the end of treatment and 3 and 6 months after treatment,the KPS scores of the observation group were(87.6±5.7),(85.5±4.3)and(85.8±5.2)points,respectively,which were significantly higher than those of the control group(86.3±5.4),(78.5±4.1)and(79.7±5.4)points,the differences were statistically significant(P<0.05).As of the follow-up endpoint,the median progression-free survival(PFS)of the control group was 4.00 months(95%CI:1.65-6.35),and the median overall survival(OS)was 8.00 months(95%CI:6.85-9.15);the median PFS of the observation group was 5.00 months(95%CI:2.06-7.94),and the median OS was 10.00 months(95%CI:8.90-11.10).The median PFS and OS of the observation group were higher than those of the control group,and the difference in survival curve area between the two groups was statistically significant(P<0.05).Conclusion Sindilizmab injection combined with paclitaxel(albumin-binding type)in patients with relapsed or metastatic advanced NSCLC showed clinically effective results,prolonged PFS and O

关 键 词：信迪利单抗注射液 晚期肺癌 免疫治疗 化疗 

分 类 号：R734.2[医药卫生—肿瘤]