目的 探讨安罗替尼与DP方案（多西他赛+顺铂）联合治疗晚期非小细胞肺癌的临床效果。方法 选择2018年1月—2021年12月亳州市人民医院收治的100例晚期非小细胞肺癌患者，随机分为对照组和治疗组，每组各50例。对照组给予DP方案化疗，每个周期的第1天静脉滴注多西他赛注射液，75mg/m²，同时静脉滴注顺铂注射液75mg/m²。在对照组基础上，治疗组口服盐酸安罗替尼胶囊，12mg/次，1次/d。以21d为1个周期，两组均连续治疗4个周期。观察两组患者临床疗效，比较治疗前后两组患者癌症治疗功能评价系统-肺癌模块（FACT-L）评分和卡氏功能状态量表（KPS）评分，血清鳞状上皮细胞癌抗原（SCC）、癌胚抗原（CEA）和细胞角蛋白片段19（CYFRA21-1）水平，及血管生成调节因子血管内皮生长因子（VEGF）、内皮抑素（ES）和基质金属蛋白酶-9（MMP-9）水平。结果 治疗后，治疗组疾病控制率（DCR）比对照组（84.0%vs70.0%）、客观缓解率（ORR）比对照组（68.0%vs52.0%）均显著升高（P<0.05）。与治疗前相比，治疗后两组FACT-L评分和KPS评分均显著升高（P<0.05），且以治疗组的升高更显著（P<0.05）。相比治疗前，治疗后两组血清SCC、CEA、CYFRA21-1、VEGF、MMP-9水平均显著降低，而ES水平则均显著升高（P<0.05），且均以治疗组的改善更显著（P<0.05）。结论 安罗替尼与DP方案联用治疗晚期非小细胞肺癌能取得较为满意的疗效，可明显提高患者生存质量，降低体内肿瘤标志物水平，且患者耐受性较好。

Objective To investigate the clinical effect of anlotinib combined with DP regimen in treatment of advanced non-small cell lung cancer. Methods Patients (100 cases) with advanced non-small cell lung cancer in the People’s Hospital of Bozhou from January 2018 to December 2021 were randomly divided into control and treatment group, and each group had 50 cases. Patients in the control group were administered with DP chemotherapy, including intravenous drip of Docetaxel Injection, 75 mg/m², and patients were also iv administered with Cisplatin Injection at the first day per cycle, 75 mg/m². Patients in the treatment group were po administered with Anlotinib Hydrochloride Capsules on the basis of control group, 12 mg/time, once daily. 21 d was one cycle, and they were both treated for 4 cycles of continuous treatment. After treatment, the clinical evaluation was evaluated, the FACT-L score and KPS scores, tumor marker SCC, CEA and CYFRA21-1 levels, the levels of serum angiogenesis regulators VEGF, ES and MMP-9 in two groups before and after treatment were compared. Results After treatment, the disease control rate (DCR) and objective response rate (ORR) of the treatment group were 84.0% and 68.0%, respectively, which were significantly higher than those of the control group (70.0% and 52.0%) (P < 0.05). Compared with before treatment, the FACT-L score and KPS score in two groups after treatment were significantly increased (P < 0.05), and which in the treatment group were higher than that in the control group (P< 0.05). Compared with those before treatment, the serum levels of SCC, CEA, CYFRA21-1, VEGF and MMP-9 were significantly decreased, while the level of ES were significantly increased in two groups after treatment (P < 0.05), and these factors levels in the treatment group were significantly better than those in the control group (P < 0.05). Conclusion The combination of amlotinib and DP regimen can achieve satisfactory anti-tumor effect in the treatment of advanced non-small cell lung cancer, which can significantly improve the quality of life of patients, reduce the level of tumor markers in vivo, and the patients are well tolerated.

R979.1

国家创新药重点监测专项科研基金资助项目（E-2018-32-190033）