目的 探讨注射用黄芪多糖联合AP方案治疗晚期非小细胞肺癌的有效性与安全性。方法 选择2020年1月—2021年12月天津市第五中心医院收治的124例晚期非小细胞肺癌患者，按随机数字表法将分为对照组和治疗组，每组各62例。对照组采取AP方案治疗，即第1天静脉滴注注射用培美曲塞二钠，500mg/m²溶于100mL生理盐水；滴注完30min后再静脉滴注注射用顺铂注射用顺铂，75mg/m²溶于500mL生理盐水。在对照组基础上，治疗组第1～14天静滴滴注注射用黄芪多糖，250mg加入500mL生理盐水，1次/d。所有患者均以21d为1个疗程，连续治疗4个疗程。观察两组患者临床疗效，比较治疗前后两组患者血清细胞角蛋白片段19（CYFRA21-1）、鳞状上皮细胞癌抗原（SCC-Ag）、癌胚抗原（CEA）、白细胞介素-8（IL-8）和转化生长因子-β1（TGF-β1）水平，FACT-L评分，及外周血CD3⁺、CD4⁺水平和CD4⁺/CD8⁺和不良反应。结果 治疗后，治疗组疾病控制率（DCR）比对照组（88.71%vs70.97%）、客观缓解率（ORR）比对照组（51.61%vs33.87%）均显著升高（P<0.05）。治疗后，两组血清肺癌标志物CYFRA21-1、SCC-Ag、CEA、IL-8和TGF-β1水平均显著低于治疗前（P<0.05），且以治疗组的下降更显著（P<0.05）。治疗后，两组FACT-L中评分及其总分比治疗前均显著增加（P<0.05），且以治疗组的升高更显著（P<0.05）。治疗后，对照组外周血CD3⁺、CD4⁺水平和CD4⁺/CD8⁺比值治疗前均显著下降，而治疗组治疗后CD3⁺、CD4⁺水平和CD4⁺/CD8⁺比值显著升高（P<0.05）；且治疗后治疗组患者外周血CD3⁺、CD4⁺水平和CD4⁺/CD8⁺比值高于对照组（P<0.05）。治疗组白细胞减少发生率（12.90%vs32.26%）、胃肠道反应发生率（12.90%vs29.03%）、血小板减少发生率（11.29%vs25.81%）均较对照组显著下降（P<0.05）。结论 注射用黄芪多糖对AP方案具有增效减毒的功效，有望成为晚期非小细胞肺癌治疗方案的重要组成部分。

Objective To investigate the efficacy and safety of Astragalus Polysaccharide for injection combined with AP regimen in treatment of advanced non-small cell lung cancer. Methods Patients (124 cases) with advanced non-small cell lung cancer in Tianjin Fifth Central Hospital from January 2020 to December 2021 were randomly divided into control and treatment group, and each group had 62 cases. Patients in the control group were administered with AP regimen, Pemetrexed Disodium for injection was dissolved in 100 mL saline for 500 mg/m² by intravenous drip, and Cisplatin for injection was administered intravenously after Pemetrexed Disodium for injection after 30 min and 75 mg/m² in 500 mL saline, d1. Patients in the treatment group were iv administered with Astragalus Polysaccharide for injection on the basis of the control group, 250 mg dissolved in 500 mL saline, once daily, d1 — d14. All patients were treated with 21 d as a course of treatment for 4 consecutive courses. After treatment, the clinical evaluation was evaluated, the levels of serum CYFRA21-1, SCC-Ag, CEA, IL-8 and TGF-β1, FACT-L scores, CD3⁺, CD4⁺ and CD4⁺/CD8⁺ of peripheral blood, and adverse reactions in two groups before and after treatment were compared. Results After treatment, the disease control rate (DCR) of the treatment group was significantly higher than that of the control group (88.71% vs 70.97%), and the objective remission rate (ORR) was significantly higher than that of the control group (51.61% vs 33.87%). After treatment, the levels of serum lung cancer markers CYFRA21-1, SCC-Ag, CEA, IL-8 and TGF-β1 in two groups were significantly lower than those before treatment (P < 0.05), and especially in the treatment group (P< 0.05). After treatment, the FACT-L score and its total score in twp groups were significantly higher than those before treatment (P < 0.05), and especially in the treatment group (P < 0.05). After treatment, the levels of CD3⁺, CD4⁺ and the ratio of CD4⁺/CD8⁺ in peripheral blood of the control group were significantly decreased before treatment, while the levels of CD3⁺, CD4⁺ and the ratio of CD4⁺/CD8⁺ were significantly increased in the treatment group after treatment (P < 0.05). After treatment, the levels of CD3⁺, CD4⁺ and the ratio of CD4⁺/CD8⁺ in peripheral blood of the treatment group were higher than those of the control group (P < 0.05). The incidence of leukopenia (12.90% vs 32.26%), gastrointestinal reaction (12.90% vs 29.03%) and thrombocytopenia (11.29% vs 25.81%) in the treatment group were significantly lower than those in the control group (P < 0.05). Conclusion Astragalus Polysaccharide for injection combined with AP regimen in treatment of advanced non-small cell lung cancer has the effect of increasing efficiency and reducing toxicity, and which is expected to become an important part of the treatment of advanced non-small cell lung cancer.

R979.1

天津市科技计划项目（20JCZDJC99240）