作者：刘晶晶，易良杰

单位：

516000广东省惠州市，广州中医药大学惠州医院肿瘤科

单位（英文）：

Department of Oncology, Huizhou Hospital of Guangzhou University of Traditional Chinese Medicine, Huizhou 516000, China

关键词：

　癌，非小细胞肺；参芪扶正注射液；卡瑞利珠单抗；化疗；治疗结果

关键词（英文）：

Carcinoma, non-small-cell lung; Shenqi Fuzheng injection; Carrilizumab; Chemotherapy; Treatment outcome

中图分类号：

R 730.26

DOI：

10.12114/j.issn.1008-5971.2024.00.048

基金项目：

广东省中医药局科研项目（20231347）

摘要：

目的　观察参芪扶正注射液辅助卡瑞利珠单抗联合化疗一线治疗晚期非小细胞肺癌（NSCLC）的 临床疗效。方法　选取2021年4月—2023年4月广州中医药大学惠州医院收治的96例晚期NSCLC患者为研究对象，采 用随机数字表法将患者分为对照组和观察组，每组48例。对照组患者采用卡瑞利珠单抗联合化疗一线治疗，观察组 患者在对照组基础上接受参芪扶正注射液辅助治疗，21 d为1个周期，连续治疗4个周期。比较两组患者临床疗效、 Ⅲ～Ⅳ级毒副作用发生率及治疗前后T淋巴细胞亚群、血清细胞角质蛋白19片段抗原21-1（CYFRA21-1）水平、血 清趋化因子CXCL12水平、中文版肺癌患者生活质量测定量表（FACT-L）评分。结果　观察组患者疾病控制率为 81.2%（39/48）、客观缓解率为62.5%（30/48），分别高于对照组的41.7%（20/48）、31.2%（15/48）（P＜0.05）。 观察组患者Ⅲ～Ⅳ级毒副作用发生率为25.0%（12/48），低于对照组的45.8%（22/48）（P＜0.05）。治疗后，两 组患者CD3 + T淋巴细胞、CD4 + T淋巴细胞百分比分别高于本组治疗前，且观察组患者高于对照组（P＜0.05）。治疗 后，两组患者血清CYFRA21-1、趋化因子CXCL12水平及FACT-L评分分别低于本组治疗前，且观察组患者低于对照 组（P＜0.05）。结论　参芪扶正注射液辅助卡瑞利珠单抗联合化疗一线治疗可提高晚期NSCLC患者临床疗效，减少 Ⅲ～Ⅳ级毒副作用，改善患者免疫功能和生活质量，降低患者肿瘤标志物水平。

英文摘要：

Objective To observe the clinical efficacy of Shenqi Fuzheng injection adjuvant carrelizumab combined with chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) . Methods A total of 96 patients with advanced NSCLC admitted to Huizhou Hospital of Guangzhou University of Traditional Chinese Medicine from April 2021 to April 2023 were selected as the research objects. The patients were divided into control group and observation group by random number table method, with 48 cases in each group. The patients in the control group were treated with carrelizumab combined with chemotherapy as the first-line treatment. The patients in the observation group were treated with Shenqi Fuzheng injection adjuvant carrelizumab on the basis of the control group. Twenty-one was a treatment cycle, and the patients were continuously treated for 4 cycles. The clinical efficacy, incidence of toxic and side effects of grade Ⅲ-Ⅳ, T lymphocyte subsets, serum cyto keratin 19 fragment antigen 21-1 (CYFRA21-1) level, chemokine CXCL12 level and Chinese version Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) score before and after treatment were compared between the two groups. Results The disease control rate was 81.2% (39/48) and the objective remission rate was 62.5% (30/48) in the observation group, which were higher than 41.7% (20/48) and 31.2% (15/48) in the control group, respectively (P < 0.05) . The incidence of toxic and side effects of grade Ⅲ-Ⅳ in the observation group was 25.0 % (12/48) , which was lower than 45.8 % (22/48) in the control group (P < 0.05) . After treatment, the percentages of CD3 + T lymphocytes and CD 4 + T lymphocytes in the two groups were higher than those before treatment, respectively, and those in the observation group were higher than those in the control group (P < 0.05) . After treatment, the levels of serum CYFRA21-1 and chemokine CXCL12 and Chinese version FACT-L score in the two groups were lower than those before treatment, respectively, and those in the observation group were lower than those in the control group (P < 0.05) . Conclusion Shenqi Fuzheng injection adjuvant carrelizumab combined with chemotherapy first-line treatment can improve the clinical efficacy of patients with advanced NSCLC, reduce the toxic and side effects of grade Ⅲ-Ⅳ, improve the immune function and quality of life of patients, and reduce the level of tumor markers of patients.

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