目的 探讨榄香烯注射液联合培美曲塞和顺铂（AP方案）治疗晚期非小细胞肺癌的临床疗效。方法 选取2020年1月—2021年1月南通市肿瘤医院收治的79例晚期非小细胞肺癌患者，采用随机数字表法将所有患者分为对照组（39例）和治疗组（40例）。对照组患者第1天静脉滴注注射用培美曲塞二钠，500 mg/m²与100 mL生理盐水混合，30 min内滴注完成。间隔30 min再静滴顺铂注射液，75 mg/m²与500 mL生理盐水混合，200 min滴注内完成。在对照组治疗的基础上，治疗组静脉滴注榄香烯注射液，600 mg与500 mL生理盐水混合，1次/d，连续滴注7 d。以7 d为1个疗程，2个疗程之间间隔21 d，两组患者共治疗4个疗程。观察两组的近期临床疗效，比较两组卡氏功能量表（KPS）评分、肺癌生存质量评价量表（FACT-L）评分、T淋巴细胞亚群水平、肿瘤标志物水平、不良反应和总生存期（OS）。结果 治疗后，治疗组患者客观缓解率（ORR）、疾病控制率（DCR）均明显高于对照组，差异有统计学意义（P＜0.05）。治疗后，两组患者KPS评分、FACT-L评分均显著升高（P＜0.05），且治疗组KPS评分、FACT-L评分明显高于对照组，差异有统计学意义（P＜0.05）。治疗后，对照组CD4^＋/CD8^＋、CD3^＋、CD4^＋、CD8^＋均显著降低，治疗组患者CD4^＋/CD8^＋、CD3^＋、CD4^＋显著升高，CD8^＋显著下降，差异有统计学意义（P＜0.05）；治疗后，治疗组患者CD4^＋/CD8^＋、CD3^＋、CD4^＋显著高于对照组，CD8^＋显著低于对照组，差异有统计学意义（P＜0.05）。治疗后，两组患者血清癌胚抗原（CEA）、糖类抗原125（CA125）、糖类抗原199（CA199）水平均显著下降（P＜0.05），且治疗组血清CEA、CA125、CA199水平低于对照组（P＜0.05）。治疗组Ⅲ、Ⅳ度不良反应发生率低于对照组，差异有统计学意义（P＜0.05）。随访1年，对照组中位生存期为4个月，治疗组患者中位生存期为6个月，治疗组OS较对照组明显延长（P＝0.030）。结论 榄香烯注射液联合AP方案治疗晚期非小细胞肺癌可改善患者生活质量、功能状态，调节T淋巴细胞亚群表达，降低肿瘤标志物水平，降低不良反应程度，延长生存时间。

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

江苏省药学会-正大天晴医院药学基金科研项目（Q202128）