作者：薛倩1 ，何强1 ，陈虹1 ，吴红海1 ，许佳睿1 ，侯春立2

单位：

1.050000河北省石家庄市，中国人民解放军联勤保障部队第九八〇医院临床药学科　2.050000河北省石家 庄市，中国人民解放军联勤保障部队第九八〇医院肿瘤科

单位（英文）：

1.Department of Clinical Pharmacy, the 980th Hospital of the Joint Logistics Support Force of PLA, Shijiazhuang 050000, China 2.Department of Oncology, the 980th Hospital of the Joint Logistics Support Force of PLA, Shijiazhuang 050000, China

关键词：

癌，非小细胞肺；免疫检查点抑制剂；血管生成抑制剂；榄香烯；卡瑞利珠单抗；治疗结果

关键词（英文）：

　Carcinoma, non-small-cell lung; Immune checkpoint inhibitors; Angiogenesis inhibitors; Elemene; Camrelizumab; Treatment outcome

中图分类号：

R 730.26

DOI：

10.12114/j.issn.1008-5971.2024.00.024

基金项目：

2022年度河北省医学科学研究课题项目（20220276）

摘要：

目的　探讨卡瑞利珠单抗联合重组人血管内皮抑制素及榄香烯治疗晚期非小细胞肺癌（NSCLC）的 有效性及安全性。方法　选取2019年7月—2020年7月中国人民解放军联勤保障部队第九八〇医院收治的首次就诊的 100例晚期NSCLC患者为研究对象，采用随机数字表法将其分为联合治疗组与常规治疗组，各50例。患者入院后均行 常规对症支持治疗，后采用一线化疗方案治疗。常规治疗组在化疗基础上采用重组人血管内皮抑制素联合榄香烯注 射液治疗；联合治疗组在常规治疗组基础上采用卡瑞利珠单抗注射液治疗，21 d为1个疗程，均连续治疗3个疗程。 比较两组治疗后客观缓解率（ORR）、疾病控制率（DCR），治疗前后肿瘤标志物〔糖类抗原125（CA125）、癌胚 抗原（CEA）、细胞角蛋白19片段抗原21-1（CYFRA21-1）〕，治疗期间毒副作用发生率。随访36个月，随访截至 2023-07-31，记录两组总生存时间（OS）和无进展生存时间（PFS）。结果　治疗后，联合治疗组ORR和DCR高于 常规治疗组（P＜0.05）。治疗后两组CA125、CEA及CYFRA21-1分别低于本组治疗前，且联合治疗组CA125、CEA 及CYFRA21-1低于常规治疗组（P＜0.05）。治疗期间，联合治疗组和常规治疗组Ⅰ～Ⅱ级、Ⅲ～Ⅳ级神经系统损 伤、甲状腺功能减退、胃肠道反应、蛋白尿发生率比较，差异无统计学意义（P＞0.05）。随访期间常规治疗组失访6 例，联合治疗组失访4例。常规治疗组患者中位OS为9.0个月，生存率为27.3%；联合治疗组患者中位OS为27.5个月， 生存率为45.7%。联合治疗组生存率高于常规治疗组（P＜0.05）。常规治疗组患者中位PFS为7.0个月，无进展生存 率为13.6%；联合治疗组患者中位PFS为24.5个月，无进展生存率为28.3%。联合治疗组无进展生存率高于常规治疗组 （P＜0.05）。结论　卡瑞利珠单抗联合重组人血管内皮抑制素及榄香烯能有效提高晚期NSCLC患者近期临床疗效，降 低肿瘤标志物水平，提高生存率及无进展生存率，同时未增加患者毒副作用发生情况。

英文摘要：

Objective To investigate the efficacy and safety of camrelizumab combined with recombinant human endostat and elemene in the treatment of advanced non-small cell lung cancer (NSCLC) . Methods A total of 100 patients with advanced NSCLC admitted to the 980th Hospital of the Joint Logistics Support Force of PLA for the first time from July 2019 to July 2020 were selected as the research objects. The patients were divided into combined treatment group (n=50) and conventional treatment group (n=50) using a random number table method. After admission, all patients were given routine symptomatic supportive treatment and then were treated with first-line chemotherapy regimen. The conventional treatment group was treated with recombinant human endostat and elemene injection on the basis of chemotherapy, while combined treatment group was treated with camrelizumab injection on the basis of conventional treatment group. All were treated for 3 courses (21 d/course) . The objective response rate (ORR) and disease control rate (DCR) after treatment, tumor markers [carbohydrate antigen 125 (CA125) , carcinoembryonic antigen (CEA) , cytokeratin 19 fragment antigen 21-1 (CYFRA21-1) ] before and after treatment, and the incidence of side effects during the treatment were compared between the two groups. The patients were followed up for 36 months, until July 31, 2023, and the overall survival (OS) and progression-free survival (PFS) in the two groups were recorded. Results After treatment, ORR and DCR in combined treatment group were higher than those in conventional treatment group (P < 0.05) . After treatment, CA125, CEA and CYFRA21-1 in the two groups were lower than those before treatment respectively, CA125, CEA and CYFRA21-1 in combined treatment group were lower than those in conventional treatment group (P < 0.05) . During treatment, there was no significant difference in the incidence of grade Ⅰ-Ⅱand grade Ⅲ-Ⅳ nervous system injury, hypothyroidism, gastrointestinal reactions and proteinuria between the two groups (P > 0.05) . During follow-up period, 6 cases were lost in the conventional treatment group and 4 cases were lost in the combined treatment group. The median OS of patients in the conventional treatment group was 9.0 months and the overall survival rate was 27.3%; the median OS of patients in the combined treatment group was 27.5 months and the overall survival rate was 45.7% . The survival rate in the combined treatment group was higher than that in the conventional treatment group (P < 0.05) . The median PFS of patients in the conventional treatment group was 7.0 months and the progression-free survival rate was 13.6%; the median PFS of patients in the combined treatment group was 24.5 months and the progression-free survival rate was 28.3%. The progression-free survival rate in the combined treatment group was higher than that in the conventional treatment group (P < 0.05) . Conclusion Camrelizumab combined with recombinant human endostat and elemene can effectively improve short-term curative effect of advanced NSCLC patients, decrease the level of tumor markers, increase overall survival rate and progression-free survival rate, and do not increase the incidence of side effects.

参考文献：