目的 探討鴉膽子油乳注射液聯(lián)合AP方案治療晚期非小細胞肺癌的臨床療效。方法 選取2019年12月—2022年1月在太倉市中醫(yī)醫(yī)院就診的80例晚期非小細胞肺癌患者，按照隨機數(shù)字表法將80例患者隨機分為對照組和治療，每組各40例。對照組患者給予AP方案治療，第1天靜脈滴注注射用培美曲塞二鈉，500mg/m²，第1～3天靜脈滴注順鉑注射液，25mg/m²。治療組在對照組基礎(chǔ)上靜脈滴注鴉膽子油乳注射液，20mL加入250mL生理鹽水中，1次/d，連續(xù)治療14d后停止7d。21d為1個療程，兩組患者連續(xù)治療3個療程。觀察兩組的臨床療效，比較兩組的肺功能指標、生活質(zhì)量、血清中基質(zhì)金屬蛋白酶2（MMP-2）、堿性成纖維細胞生長因子（bFGF）、細胞角蛋白21-1片段（CYFRA21-1）水平以及藥物不良反應。結(jié)果 治療后，治療組的有效率82.50%明顯高于對照組的有效率62.50%，差異有統(tǒng)計學意義（P<0.05）。治療后，治療組的用力肺活量（FVC）、第1秒用力呼氣的容積占預計值的百分比（FEV1% pred）、一秒用力呼氣容積（FEV1）均顯著升高（P<0.05），且治療組的FVC、FEV1% pred、FEV1均高于對照組（P<0.05）。治療后，兩組的生命質(zhì)量測定量表（QLQ-LC43）評分均顯著降低（P<0.05），并且治療組QLQ-LC43評分明顯低于對照組，差異有統(tǒng)計學意義（P<0.05）。治療后，兩組的血清MMP-2、bFGF、CYFRA21-1水平較治療前降低（P<0.05）；治療組的血清MMP-2、bFGF、CYFRA21-1水平低于對照組，差異有統(tǒng)計學意義（P<0.05）。治療組消化道反應、腎毒性、骨髓抑制、肝功能異常發(fā)生例數(shù)少于對照組（P<0.05）。結(jié)論 鴉膽子油乳注射液聯(lián)合AP方案可提高晚期非小細胞肺癌的臨床療效，改善患者的肺功能和生活質(zhì)量，調(diào)節(jié)血清MMP-2、bFGF、CYFRA21-1水平，安全性較好。

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

太倉市科技計劃項目（TC2019JCYL14）