目的 探討欖香烯注射液聯(lián)合培美曲塞和順鉑（AP方案）治療晚期非小細(xì)胞肺癌的臨床療效。方法 選取2020年1月—2021年1月南通市腫瘤醫(yī)院收治的79例晚期非小細(xì)胞肺癌患者，采用隨機數(shù)字表法將所有患者分為對照組（39例）和治療組（40例）。對照組患者第1天靜脈滴注注射用培美曲塞二鈉，500 mg/m²與100 mL生理鹽水混合，30 min內(nèi)滴注完成。間隔30 min再靜滴順鉑注射液，75 mg/m²與500 mL生理鹽水混合，200 min滴注內(nèi)完成。在對照組治療的基礎(chǔ)上，治療組靜脈滴注欖香烯注射液，600 mg與500 mL生理鹽水混合，1次/d，連續(xù)滴注7 d。以7 d為1個療程，2個療程之間間隔21 d，兩組患者共治療4個療程。觀察兩組的近期臨床療效，比較兩組卡氏功能量表（KPS）評分、肺癌生存質(zhì)量評價量表（FACT-L）評分、T淋巴細(xì)胞亞群水平、腫瘤標(biāo)志物水平、不良反應(yīng)和總生存期（OS）。結(jié)果 治療后，治療組患者客觀緩解率（ORR）、疾病控制率（DCR）均明顯高于對照組，差異有統(tǒng)計學(xué)意義（P＜0.05）。治療后，兩組患者KPS評分、FACT-L評分均顯著升高（P＜0.05），且治療組KPS評分、FACT-L評分明顯高于對照組，差異有統(tǒng)計學(xué)意義（P＜0.05）。治療后，對照組CD4^＋/CD8^＋、CD3^＋、CD4^＋、CD8^＋均顯著降低，治療組患者CD4^＋/CD8^＋、CD3^＋、CD4^＋顯著升高，CD8^＋顯著下降，差異有統(tǒng)計學(xué)意義（P＜0.05）；治療后，治療組患者CD4^＋/CD8^＋、CD3^＋、CD4^＋顯著高于對照組，CD8^＋顯著低于對照組，差異有統(tǒng)計學(xué)意義（P＜0.05）。治療后，兩組患者血清癌胚抗原（CEA）、糖類抗原125（CA125）、糖類抗原199（CA199）水平均顯著下降（P＜0.05），且治療組血清CEA、CA125、CA199水平低于對照組（P＜0.05）。治療組Ⅲ、Ⅳ度不良反應(yīng)發(fā)生率低于對照組，差異有統(tǒng)計學(xué)意義（P＜0.05）。隨訪1年，對照組中位生存期為4個月，治療組患者中位生存期為6個月，治療組OS較對照組明顯延長（P＝0.030）。結(jié)論 欖香烯注射液聯(lián)合AP方案治療晚期非小細(xì)胞肺癌可改善患者生活質(zhì)量、功能狀態(tài)，調(diào)節(jié)T淋巴細(xì)胞亞群表達(dá)，降低腫瘤標(biāo)志物水平，降低不良反應(yīng)程度，延長生存時間。

Objective To investigate the clinical efficacy of Elemene Injection combined with pemetrexed and cisplatin (AP) chemotherapy scheme in treatment of advanced non-small cell lung cancer. Methods Patients (79 cases) with advanced non-small cell lung cancer in Nantong Tumor Hospital from January 2020 to January 2021 were divided into the control group (39 cases) and the treatment group (40 cases) according to random number table method. Patients in the control group were iv administered with Pemetrexed Disodium for injection at the first day, 500 mg/m² added into normal saline 100 mL, completed the infusion within 30 min. At 30 min intervals, patients in the control group were iv administered with Cisplatin Injection, 75 mg/m² added into normal saline 500 mL, completed the infusion within 200 min. Patients in the treatment group were iv administered with Elemene Injection on the basis of the control group, 600 mg added into normal saline 500 mL, once daily, continuous infusion for 7 d. Take 7 d as a course of treatment, the interval between two courses of treatment was 21 d, and patients in two groups were treated for 4 courses. After treatment, the clinical efficacies were evaluated, and KPS scores, FACT-L scores, T lymphocyte subpopulation level, the levels of tumor markers, adverse reactions, and OS of two groups were compared. Results After treatment, ORR and DCR of patients in the treatment group were significantly higher than those in the control group (P < 0.05). After treatment, KPS score and FACT-L score of two groups were significantly increased (P < 0.05), and KPS score and FACT-L score of the treatment group were significantly higher than those of the control group (P < 0.05). After treatment, the CD4⁺/CD8⁺, CD3⁺, CD4⁺, and CD8⁺ in the control group were significantly decreased, but CD4⁺/CD8⁺, CD3⁺, and CD4⁺ in the treatment group were significantly increased, but the CD8⁺ in the treatment group were significantly decreased (P < 0.05). After treatment, the CD4⁺/CD8⁺, CD3⁺, CD4⁺ in the treatment group were significantly higher than those in the control group, but the CD8⁺ in the treatment group was significantly lower than that in the control group, with a statistically significant difference (P < 0.05). After treatment, the serum levels of CEA, CA125, and CA199 in two groups were significantly decreased (P < 0.05), and the serum levels of CEA, CA125, and CA199 in the treatment group were lower than those in the control group (P < 0.05). The incidence of grade III and IV adverse reactions in the treatment group was lower than that in the control group, with a statistically significant difference (P < 0.05). During 1-year follow-up, the median survival period of patients in the control group was 4 months, and that of patients in the treatment group was 6 months. The OS in the treatment group was significantly longer than that in the control group (P＝0.030). Conclusion Elemene injection combined with AP chemotherapy scheme has a good therapeutic effect in treatment of advanced non-small cell lung cancer, can improve the quality of life and functional status, regulate the expression of T lymphocyte subsets, reduce the level of tumor markers, reduce the degree of adverse reactions, and prolong the survival time.

R979.1

江蘇省藥學(xué)會-正大天晴醫(yī)院藥學(xué)基金科研項目（Q202128）