宜肺扶正抗癌汤联合信迪利单抗、培美曲塞治疗晚期非鳞非小细胞肺癌的临床效果

米虽才 陈志明 罗建文

[摘要] 目的 探讨宜肺扶正抗癌汤联合信迪利单抗、培美曲塞治疗晚期非鳞非小细胞肺癌的临床疗效。 方法 选择2019年2月至2020年4月厦门市中医院肿瘤科收治的晚期非鳞非小细胞肺癌患者56例，分为对照组（28例）和观察组（28例），对照组予信迪利单抗联合培美曲塞治疗，观察组加用宜肺扶正抗癌汤治疗。比较两组的治疗疗效，对患者免疫功能、生存质量评分的影响，及药物相关不良事件发生情况。 结果 治疗3个月后，观察组的疾病控制率达到96.43%;客观缓解率为67.86%，显著高于对照组，差异有统计学意义（P<0.05）。观察组患者的CD3+、CD4+、CD4+/CD8+指标水平较治疗前升高，且显著高于对照组;CD8+指标水平降低，且低于对照组，差异有统计学意义（P<0.05）。两组患者在生存质量评分中的生理职能、躯体疼痛方面较治疗前均有所提高，且观察组的获益更加显著，差异有统计學意义（P<0.05）。两组患者均未出现严重的药物相关不良事件，观察组红/白细胞减少、肝肾功能损伤、血小板降低、肺炎不良事件发生率低于对照组，差异有统计学意义（P<0.05）。 结论 宜肺扶正抗癌汤联合信迪利单抗、培美曲塞治疗晚期非鳞非小细胞肺癌的疗效较好，可提高治疗疗效，使患者的免疫功能改善、生存质量提升，并减少药物不良事件的发生。

[关键词] 非小细胞肺癌;宜肺扶正抗癌汤;信迪利单抗;培美曲塞;治疗疗效

[Abstract] Objective To explore the clinical efficacy of Yifei Fuzheng Anti-tumor Decoction combined with Sintilizumab and Pemetrexed in the treatment of advanced non-squamous non-small cell lung cancer. Methods A total of 56 patients admitted to department of oncology， Xiamen Hospital of Traditional Chinese Medicine from February 2019 to April 2020 were divided into the control group（28 cases） and the observation group （28 cases）. The control group was treated with sintilimab combined with pemetrexed. The observation group was also treated with Yifei Fuzheng Anti-cancer Decoction. The therapeutic effect of the two groups， the influence on the patient′s immune function， quality of life score， and the occurrence of drug-related adverse events were compared. Results After three months of treatment， the disease control rate of the observation group reached 96.43%. The objective remission rate of the observation group was 67.86%， which was significantly higher than that of the control group（P<0.05）. The CD3+， CD4+， CD4+/CD8+ levels of the observation group were higher than before treatment and significantly higher than those of the control group， and the CD8+ levels decreased and were lower than those of the control group（P<0.05）. The physiological functions and physical pain in the quality of life scores of the two groups were improved compared with before treatment， and the benefit of the observation group was more significant（P<0.05）. There were no drug-related severe adverse events in both groups. The adverse events such as red/white blood cell reduction， liver and kidney function damage， platelet reduction， and pneumonia in the observation group were significant lower than that in the control group（P<0.05）. Conclusion Yifei Fuzheng Anti-cancer Decoction combined with sintilizumab and pemetrexed is effective in the treatment of advanced non-squamous non-small cell lung cancer， which can improve the therapeutic effect， improve the patient′s immune function， improve the quality of life， and reduce the adverse drug events.

[Key words] Non-small cell lung cancer; Yifei Fuzheng Anti-tumor Decoction; Sintilimab; Pemetrexed; Therapeutic efficacy

非小细胞肺癌（Non-small cell lung cancer，NSCLC）作为常见的肺癌类型，非鳞非小细胞肺癌（Non-squamous cell non-small cell lung cancer，nsqNSCLC）占其中的绝大部分，此类患者早期诊断的特异性症状较少，大部分患者确诊时为肺癌中晚期，在患者积极配合治疗的前提下，其5年生存率依然较低[1]。近年来，以PD-1/PD-L1抑制剂为代表的免疫检查点抑制剂（Immune checkpoint inhibitors，ICIs）在肺癌治療过程中使部分患者的生存时间得到了明显延长[2-3]。

信迪利单抗是PD-1/PD-L1抑制剂药物之一，目前正在我国进行多项用于NSCLC治疗的临床试验[4]。为最大程度地提升治疗疗效，本研究引入中医药联合信迪利单抗、培美曲塞治疗晚期nsqNSCLC，经临床验证，取得了较为理想的治疗效果，现报道如下。

1 资料与方法

1.1一般资料

选择2019年2月至2020年4月厦门市中医院肿瘤科收治的晚期nsqNSCLC患者56例为研究对象。纳入标准[5]：①经病理组织学确诊为nsqNSCLC Ⅲb期、Ⅳ期，经基因检测无驱动基因突变，或TKI治疗失败后，且TPS≥1%，生存时间>180 d;②患者或家属知情并同意参与本研究;③完整接受治疗疗程，且治疗依从性较理想，资料保存完整。排……