目的 探讨鸦胆子油乳注射液联合AP方案治疗晚期非小细胞肺癌的临床疗效。方法 选取2019年12月—2022年1月在太仓市中医医院就诊的80例晚期非小细胞肺癌患者，按照随机数字表法将80例患者随机分为对照组和治疗，每组各40例。对照组患者给予AP方案治疗，第1天静脉滴注注射用培美曲塞二钠，500mg/m²，第1～3天静脉滴注顺铂注射液，25mg/m²。治疗组在对照组基础上静脉滴注鸦胆子油乳注射液，20mL加入250mL生理盐水中，1次/d，连续治疗14d后停止7d。21d为1个疗程，两组患者连续治疗3个疗程。观察两组的临床疗效，比较两组的肺功能指标、生活质量、血清中基质金属蛋白酶2（MMP-2）、碱性成纤维细胞生长因子（bFGF）、细胞角蛋白21-1片段（CYFRA21-1）水平以及药物不良反应。结果 治疗后，治疗组的有效率82.50%明显高于对照组的有效率62.50%，差异有统计学意义（P<0.05）。治疗后，治疗组的用力肺活量（FVC）、第1秒用力呼气的容积占预计值的百分比（FEV1% pred）、一秒用力呼气容积（FEV1）均显著升高（P<0.05），且治疗组的FVC、FEV1% pred、FEV1均高于对照组（P<0.05）。治疗后，两组的生命质量测定量表（QLQ-LC43）评分均显著降低（P<0.05），并且治疗组QLQ-LC43评分明显低于对照组，差异有统计学意义（P<0.05）。治疗后，两组的血清MMP-2、bFGF、CYFRA21-1水平较治疗前降低（P<0.05）；治疗组的血清MMP-2、bFGF、CYFRA21-1水平低于对照组，差异有统计学意义（P<0.05）。治疗组消化道反应、肾毒性、骨髓抑制、肝功能异常发生例数少于对照组（P<0.05）。结论 鸦胆子油乳注射液联合AP方案可提高晚期非小细胞肺癌的临床疗效，改善患者的肺功能和生活质量，调节血清MMP-2、bFGF、CYFRA21-1水平，安全性较好。

Objective To investigate the clinical efficacy of Javanica Oil Emulsion Injection combined with AP regimen in treatment of advanced non-small cell lung cancer. Methods Patients (80 cases) with advanced non-small cell lung cancer in Taicang Hospital of Traditional Chinese Medicine from December 2019 to January 2022 were randomly divided into control and treatment groups, and each group had 40 cases. Patients in the control group were given AP regimen. At the first day, patients were iv administered with Pemetrexed Disodium for injection, 500 mg/m², and at the first to third day, patients were iv administered with Cisplatin Injection, 25 mg/m². Patients in the treatment group were iv administered with Javanica Oil Emulsion Injection on the basis of the control group, 20 mL added into normal saline 250 mL. After 14 d of continuous treatment, it stopped for 7 d. A course of treatment had 21 d, and patients in two groups were consecutive treated for 3 courses. After treatment, the clinical efficacies were evaluated, and the pulmonary function indexes, quality of life, the levels of MMP-2, bFGF, and CYFRA21-1, and adverse drug reactions in two groups were compared. Results After treatment, the effective rate of 82.50% in the treatment group was significantly higher than 62.50% in the control group, and the difference was statistically significant (P < 0.05). After treatment, the FVC, FEV1% pred, and FEV1 in the treatment group were significantly increased (P < 0.05), and FVC, FEV1% pred, and FEV1 in the treatment group were higher than those in the control group (P < 0.05). After treatment, the QLQ-LC43 score of two groups were significantly decreased (P < 0.05), and the QLQ-LC43 score of the treatment group was significantly lower than that of the control group (P < 0.05). After treatment, the serum levels of MMP-2, bFGF, and CYFRA21-1 in two groups were decreased (P < 0.05). The serum levels of MMP-2, bFGF, and CYFRA21-1 in the treatment group were significantly lower than those in the control group (P < 0.05). The incidence of digestive tract reaction, nephrotoxicity, bone marrow suppression, and abnormal liver function in the treatment group was significantly lower than that in the control group (P < 0.05). Conclusion Javanica Oil Emulsion Injection combined with AP regimen can improve the clinical efficacy of advanced non-small cell lung cancer, improve the lung function and quality of life of patients, and regulate the levels of serum MMP-2, bFGF, CYFRA21-1, with good safety.

R979.1

太仓市科技计划项目（TC2019JCYL14）