目的 探討注射用黃芪多糖聯(lián)合AP方案治療晚期非小細(xì)胞肺癌的有效性與安全性。方法 選擇2020年1月—2021年12月天津市第五中心醫(yī)院收治的124例晚期非小細(xì)胞肺癌患者，按隨機(jī)數(shù)字表法將分為對照組和治療組，每組各62例。對照組采取AP方案治療，即第1天靜脈滴注注射用培美曲塞二鈉，500mg/m²溶于100mL生理鹽水；滴注完30min后再靜脈滴注注射用順鉑注射用順鉑，75mg/m²溶于500mL生理鹽水。在對照組基礎(chǔ)上，治療組第1～14天靜滴滴注注射用黃芪多糖，250mg加入500mL生理鹽水，1次/d。所有患者均以21d為1個療程，連續(xù)治療4個療程。觀察兩組患者臨床療效，比較治療前后兩組患者血清細(xì)胞角蛋白片段19（CYFRA21-1）、鱗狀上皮細(xì)胞癌抗原（SCC-Ag）、癌胚抗原（CEA）、白細(xì)胞介素-8（IL-8）和轉(zhuǎn)化生長因子-β1（TGF-β1）水平，F(xiàn)ACT-L評分，及外周血CD3⁺、CD4⁺水平和CD4⁺/CD8⁺和不良反應(yīng)。結(jié)果 治療后，治療組疾病控制率（DCR）比對照組（88.71%vs70.97%）、客觀緩解率（ORR）比對照組（51.61%vs33.87%）均顯著升高（P<0.05）。治療后，兩組血清肺癌標(biāo)志物CYFRA21-1、SCC-Ag、CEA、IL-8和TGF-β1水平均顯著低于治療前（P<0.05），且以治療組的下降更顯著（P<0.05）。治療后，兩組FACT-L中評分及其總分比治療前均顯著增加（P<0.05），且以治療組的升高更顯著（P<0.05）。治療后，對照組外周血CD3⁺、CD4⁺水平和CD4⁺/CD8⁺比值治療前均顯著下降，而治療組治療后CD3⁺、CD4⁺水平和CD4⁺/CD8⁺比值顯著升高（P<0.05）；且治療后治療組患者外周血CD3⁺、CD4⁺水平和CD4⁺/CD8⁺比值高于對照組（P<0.05）。治療組白細(xì)胞減少發(fā)生率（12.90%vs32.26%）、胃腸道反應(yīng)發(fā)生率（12.90%vs29.03%）、血小板減少發(fā)生率（11.29%vs25.81%）均較對照組顯著下降（P<0.05）。結(jié)論 注射用黃芪多糖對AP方案具有增效減毒的功效，有望成為晚期非小細(xì)胞肺癌治療方案的重要組成部分。

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

天津市科技計劃項(xiàng)目（20JCZDJC99240）