Objective  To investigate the clinical efficacy and safety of the Camrelizumab combined with Shenqi Fuzheng injection of advanced non-squamous non-small cell lung cancer (NSCLC).

Methods  Patients with advanced squamous  NSCLC diagnosed and treated in the department of medical oncology of The First Affiliated Hospital of Xi'an Jiaotong University from January 2018 to January 2023 were selected as the study subjects, and all patients were treated with pemetrexed combined with carboplatin chemotherapy. On the basis of the chemotherapy regimen, patients were divided into the Camrelizumab group (treated with Carelizumab) and the Camrelizumab+SFI group (treated with Camrelizumab+SFI). The short-term and long-term efficacy were evaluated using objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS). Survival data were analyzed using Kaplan-Meier method. The occurrence of side effects the adverse drug reactions was evaluated according to the common terminology standard for adverse events (CTCAE 4.03).

Results  A total of 95 patients with advanced NSCLC were included in this study. Among them, 48 patients were in the Camrelizumab group, and 47 patients were in the Camrelizumab+SFI group. The ORR of advanced non-squamous NSCLC patients in the Camrelizumab+SFI group and Carolizumab group were 59.57% and 45.83%, respectively (χ²=1.799, P=0.180), with DCR of 78.72% and 58.33%, respectively (χ²=4.569, P=0.033). The median PFS (8.87 months vs. 6.30 months, P=0.001 7) and median OS (9.13 months vs. 7.73 months, P=0.037) of patients in the Camrelizumab+SFI group were significantly higher than those in the Camrelizumab group. In addition, there was no significant difference in the incidence of adverse reactions between two groups (P>0.05).

Conclusion  Camrelizumab combined with Shenqi Fuzheng injection can improve the disease control rate and prolong the PFS and OS of patients with advanced non-squamous NSCLC.

1.Siegel RL, Miller KD, Fuchs HF, et al. Cancer Statistics, 2021[J]. CA Cancer J Clin, 2021, 71(1): 7-33. DOI: 10. 3322/caac.21654.

2.Soukalas N, Kiakou M, Tsapakidis K, et al. PD-1 and PD-L1 as immunotherapy targets and biomarkers in non-small cell lung cancer[J]. J BUON, 2019, 24(3): 883-888. https://pubmed.ncbi.nlm.nih.gov/31424637/.

3.柳国成, 曾荔山, 吴秀风. 血浆ProGRP与血清NSE在小细胞肺癌中的诊断价值[J]. 临床合理用药杂志, 2020, 13(7): 23-24. [Liu GC, Zeng LS, Wu XF. The diagnostic value of plasma ProGRP and serum NSE in small cell lung cancer[J]. Journal of Clinical Rational Drug Use, 2020, 13(7): 23-24.] DOI: 10.15887/j.cnki.13-1389/r.2020.07.010.

4.Goldstraw P, Chansky K, Crowley J, et al. The IASLC lung cancer staging project: proposals for revision of the TNM stage groupings in the forthcoming (eighth) edition of the TNM classification for lung cancer[J]. J Thorac Oncol, 2016, 11: 39-51. DOI: 10.1016/j.jtho.2015.09.009.

5.Zhu QG, Zhang SM, Ding XX, et al. Driver genes in non-small cell lung cancer: characteristics, detection methods, and targeted therapies[J]. Oncotarget, 2017, 8(34): 57680-57692. DOI: 10.18632/oncotarget.17016.

6.顾宁宁, 宋振鑫, 王红梅, 等. 卡瑞利珠单抗联合白蛋白结合型紫杉醇三线及以上方案治疗晚期非小细胞肺癌患者的临床疗效及其预后的影响因素研究[J]. 实用心脑肺血管病杂志, 2021, 29(6): 22-27, 33. [Gu NN, Song ZX, Wang HM, et al. A study on the clinical efficacy and prognostic factors of the combination of Carolizumab and albumin bound paclitaxel triple line and above regimen in the treatment of advanced non-small cell lung cancer patients[J]. Journal of Practical Cardiovascular Disease, 2021, 29(6): 22-27, 33.] DOI: 10.12114/j.issn.1008-5971. 2021.00.116.

7.Mo H, Huang J, Xu J, et al. Safety, anti-tumour activity, and pharmacoki-netics of fixed-dose SHR-1210, an anti-PD-1antibody in advanced solid tumours: a dose-escalation, phase1study[J]. Br J Cancer, 2018, 119(5): 538-545. DOI: 10.1038/s41416-018-0100-3.

8.王鹏, 郝朋朋, 李全奎. 一线PD-1单抗与贝伐单抗双靶联合化疗治疗晚期非鳞非小细胞肺癌临床观察[J]. 社区医学杂志, 2023, 21(20): 1052-1057. [Wang P, Hao PP, Li QK. Clinical observation of first-line PD-1monoclonal antibody and bevacizumab dual target chemotherapy in the treatment of advanced non-small cell lung cancer[J]. Journal of Community Medicine, 2023, 21(20): 1052-1057.] DOI: 10.19790/j.cnki.JCM. 2023.20.03.

9.姚凤龙, 王卫东, 郭加友. 卡瑞利珠单抗联合常规二联化疗方案用于晚期非鳞非小细胞肺癌的有效性及可行性[J]. 中外医学研究, 2022, 20(22): 18-21. [Yao FL, Wang WD, Guo JY. The efficacy and feasibility of the combination of Karelizumab and conventional dual chemotherapy regimen for advanced non-small cell lung cancer[J]. Chinese and Foreign Medical Research, 2022, 20(22): 18-21.] DOI: 10.14033/j.cnki.cfmr.2022.22.005.

10.Wan LQ, Tan Y, Jiang M, et al. The prognostic impact of traditional Chinese medicine monomers on tumor-associated macrophages in non-small cell lung cancer[J]. Chin J Nat Med, 2019, 17: 729-737. DOI: 10.1016/S1875-5364(19)30089-5.

11.Wang CY, Huang HS, Yc S, et al. Conventional treatment integrated with Chinese herbal medicine improves the survival rate of patients with advanced non-small cell lung cancer[J]. Complement Ther Med, 2018, 40: 29-36. DOI: 10.1016/j.ctim.2018.07.003.

12.陆烨, 王晨洁, 余蓉. 生脉饮加味联合化疗治疗晚期非小细胞肺癌临床研究[J]. 中医学报, 2014,29(10): 1400-1402. [Lu Y, Wang CJ, Yu R. Clinical study of modified Shengmai Yin combined with chemotherapy in the treatment of advanced non-small cell lung cancer[J]. Journal of Traditional Chinese Medicine, 2014, 29(10): 1400-1402.] DOI: 10.16368/j.issn.1674-8999. 2014.10.059.

13.李玮, 杨永丽, 胡佳佳, 等. 参芪扶正注射液联合含铂双药化疗治疗晚期非小细胞肺癌的疗效评价[J]. 中国医院药学杂志, 2022, 42(3): 299-303. [Li W, Yang YL, Hu JJ, et al. Evaluation of the efficacy of Shenqi Fuzheng injection combined with platinum containing dual drug chemotherapy in the treatment of advanced non-small cell lung cancer[J]. Chinese Journal of Hospital Pharmacy, 2022, 42(3): 299-303.] DOI: 10.13286/j.1001-5213. 2022.03.13.

14.贺卫星. 参芪扶正注射液辅助GP方案对晚期非小细胞肺癌的影响[J]. 实用中西医结合临床, 2021, 21(11): 44-45, 131. [He WX. The effect of Shenqi Fuzheng injection assisted GP regimen on advanced non-small cell lung cancer[J]. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2021, 21(11): 44-45, 131.] DOI: 10.13638/j.issn.1671-4040. 2021.11.022.

15.宋伟祥, 刘玉金, 李浏博. “清肺消积方”配合介入化疗治疗老年晚期肺癌30例临床研究[J]. 江苏中医药, 2018, 50: 34-37. [Song WX, Liu YJ, Li LB. Clinical study on the combination of "Qingfei Xiaoji Formula" and interventional chemotherapy in the treatment of30elderly patients with advanced lung cancer[J]. Jiangsu Traditional Chinese Medicine, 2018, 50: 34-37.] DOI: 10.3969/j.issn.1672-397X.2018.04.015.

16.黄坤林, 张秀美, 宋伟祥, 等. 中药辅助紫杉醇-顺铂方案经导管动脉灌注化疗治疗不可切除非小细胞肺癌的临床研究[J]. 介入放射学杂志, 2021, 30(2): 136-139. [Huang KL, Zhang XM, Song WX, et al. Clinical study on the treatment of unresectable non-small cell lung cancer with traditional Chinese medicine assisted paclitaxel cisplatin regimen via arterial infusion chemotherapy[J]. Journal of Interventional Radiology, 2021, 30(2): 136-139.] DOI: 10.3969/j.issn.1008-794X. 2021.02.007.

17.马扬, 叶海勇, 李慧琴, 等. 基于阴阳理论探讨中医药改善肿瘤微环境的途径[J]. 新中医, 2022, 54(1): 146-150. [Ma Y, Ye HY, Li HQ, et al. Exploring the pathways of traditional Chinese medicine to improve tumor microenvironment based on the theory of yin and yang[J]. New Traditional Chinese Medicine, 2022, 54(1): 146-150.] DOI: 10.13457/j.cnki.jncm.2022.01.032..

18.苏田. 扶正培元汤联合NP化疗方案治疗晚期NSCLC疗效及对血清IFN-γ, TGF-β和IL-10的影响[J]. 国际医药卫生导报, 2020, 26(20): 3. [Su T. Peiyuan Tang combined with NP chemotherapy regimen in the treatment of advanced NSCLC and its effect on serum IFN-γ, TGF-β and IL-10[J]. International Journal of Medicine and Health, 2020, 26(20): 3.] DOI: 10.3760/cma.j.issn.1007- 1245.2020.20.016.

19.Zhou CC, Chen GY, Huang YC, et al. Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial[J]. Lancet Respir Med, 2021, 9(3): 305-314. DOI: 10.1016/S2213-2600(20)30365-9.

20.雷小平, 孙雅菊. 参芪扶正注射液在晚期非小细胞肺癌患者治疗中的效果[J]. 中国医药导刊, 2023, 25(4): 425-429. [Lei XP, Sun YJ. The efficacy of Shenqi Fuzheng injection in the treatment of advanced non-small cell lung cancer patients[J]. Chinese Medical Journal, 2023, 25(4): 425-429.] DOI: 10.3969/j.issn.1009-0959.2023.04.013.

21.尚淑平, 张晓斌. 参芪扶正注射液联合NP方案对晚期非小细胞肺癌患者临床疗效[J]. 贵州医药, 2022, 46(5): 764-766. [Shang SP, Zhang XB. Clinical efficacy of Shenqi Fuzheng injection combined with NP regimen in patients with advanced non-small cell lung cancer[J]. Guizhou Medical Journal, 2022, 46(5): 764-766.] DOI: 10.3969/j.issn.1000-744X.2022.05.050.

22.吴惠珍, 邱学佳, 董占军, 等. 参芪扶正注射液联合常规化疗对晚期非小细胞肺癌患者免疫功能影响的Meta分析[J]. 中国药房, 2019, 30(22): 3143-3149. [Wu HZ, Qiu XJ, Dong ZJ, et al. Meta analysis of the effect of Shenqi Fuzheng injection combined with conventional chemotherapy on immune function in patients with advanced non-small cell lung cancer[J]. China Pharmacy, 2019, 30(22): 3143-3149.] DOI: 10.6039/j.issn. 1001-0408.2019.22.24.

23.俞欢, 费煜畅, 陈培丰. 参芪扶正注射液治疗晚期非小细胞肺癌化疗后骨髓抑制的Meta分析[J]. 浙江中西医结合杂志, 2019, 29(3): 240-244. [Yu H, Fei YC, Chen PF. Meta analysis of Shenqi Fuzheng injection in the treatment of bone marrow suppression after chemotherapy in advanced non-small cell lung cancer[J]. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2019, 29(3): 240-244.] DOI: 10.3969/j.issn.1005-4561.2019.03.026.

24.吴晋周, 靳建旭, 刘林涛. 参芪扶正注射液联合培美曲塞钠+顺铂化疗方案治疗晚期非小细胞肺癌的疗效研究[J]. 癌症进展, 2021, 19(13): 1341-1344. [Wu JZ, Jin JX, Liu LT. Study on the efficacy of Shenqi Fuzheng injection combined with pemetrexed sodium and cisplatin chemotherapy regimen in the treatment of advanced non-small cell lung cancer[J]. Cancer Progress, 2021, 19(13): 1341-1344.] DOI: 10.11877/j.issn.1672-1535. 2021.19.13.12.

25.Wang YH, Shi XH, Qi QH, et al. Safety of anlotinib capsules combined with PD-1 inhibitor camrelizumab in the third-line treatment of advanced non-small-cell lung cancer and their effect on serum tumor markers[J]. J Healthc Eng, 2021, 2021: 2338800. DOI: 10.1155/2021/2338800.

26.Gao GH, Zhao J, Ren SX, et al. Efficacy and safety of camrelizumab plus apatinib as second-line treatment for advanced squamous non-small cell lung cancer[J]. Ann Transl Med, 2022, 10(8): 441. DOI: 10.21037/atm-21-4792.

27.Huang YH, Wang J, Hu YT, et al. Microwave ablation plus camrelizumab monotherapy or combination therapy in non-small cell lung cancer[J]. Front Oncol, 2022, 12: 938827. DOI: 10.3389/fonc.2022.938827.

28.肖霄, 周阳云, 陈君君, 等. 中药注射剂抗肿瘤作用机制实验研究进展[J]. 中国药业, 2023, 32(19): 151-155. [Xiao X, Zhou YY, Chen JJ, et al. Progress in experimental research on the anti-tumor mechanism of traditional Chinese medicine injections[J]. China Pharmaceutical, 2023, 32(19): 151-155.] DOI: 10.3969/j.issn.1006-4931. 2023.19.032.

29.楼亭, 邵树巍. 参芪扶正注射液联合化疗治疗老年中晚期非小细胞肺癌患者的疗效观察[J]. 现代实用医学, 2020, 32(6): 632-634. [Lou T, Shao SW. Observation on the therapeutic effect of Shenqi Fuzheng injection combined with chemotherapy on elderly patients with advanced non-small cell lung cancer[J]. Modern Practical Medicine, 2020, 32(6): 632-634.] DOI: 10.3969/j.issn. 1671-0800.2020.06.015.

30.贾静, 张立英, 徐云霞,等. 参芪扶正注射液治疗晚期肺癌的疗效及对免疫功能、生活质量的影响[J]. 世界中西医结合杂志, 2020, 15(6): 1133-1135, 1139. [Jia J, Zhang LY, Xu YX, et al. Efficacy of Shenqi Fuzheng injection in the treatment of advanced lung cancer and its impact on immune function and quality of life[J]. World Journal of Integrated Traditional and Western Medicine, 2020, 15(6): 1133-1135, 1139.] DOI: 10.13935/j.cnki.sjzx.200637.