目的 探究回生口服液联合重组人血管内皮抑制素和奥沙利铂治疗晚期非小细胞肺癌的临床疗效及安全性。方法 选择2015年1月—2017年1月于郑州大学附属郑州中心医院诊治的晚期非小细胞肺癌患者103例，随机将患者分成对照组（51例）和治疗组（52例）。对照组患者静脉滴注重组人血管内皮抑制素注射液，第1～14天每次7.5 mg/m²溶于250 mL生理盐水中，1次/d，同时静脉滴注注射用奥沙利铂，85 mg/m²加入250 mL生理盐水，1次/14 d；治疗组在对照组基础上口服回生口服液，3次/d，10 mL/次。21 d为1个治疗周期，两组患者均连续治疗3个周期。观察两组患者近期和远期临床疗效，同时比较治疗前后两组患者肿瘤标志物水平、免疫功能指标和不良反应。结果 治疗后，对照组客观缓解率和疾病控制率分别为19.61%、45.10%，均分别显著低于治疗组的28.85%、67.31%，两组比较差异具有统计学意义（P<0.05）。治疗后，治疗组疾病进展时间要明显长，1年和2年生存率明显高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，治疗组患者血清癌胚抗原（CEA）、CA125、人鳞状细胞癌相关抗原（SCCAg）水平均显著降低（P<0.05），且治疗组患者CEA、CA125、SCCAg水平明显低于对照组（P<0.05）。治疗后，对照组CD3⁺、CD4⁺、CD4⁺/CD8⁺水平显著降低，同组治疗前后比较差异具有统计学意义（P<0.05）；治疗后治疗组血清CD3⁺、CD4⁺、CD4⁺/CD8⁺水平高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗期间，对照组不良反应发生率为27.45%，显著高于治疗组的9.62%，两组比较差异具有统计学意义（P<0.05）。结论 回生口服液联合重组人血管内皮抑制素注射液和奥沙利铂治疗晚期非小细胞肺癌疗效好，安全性高，可显著延长患者生存期。

Objective To investigate the clinical efficacy and safety of Huisheng Oral Liquid combined with recombinant human endostatin and oxaliplatin in treatment of advanced non-small cell lung cancer Methods Patients (103 cases) with advanced non-small cell lung cancer in Zhengzhou Central Hospital Affiliated to Zhengzhou University from January 2015 to January 2017 were randomly divided into control (51 cases) and treatment (52 cases) groups. Patients in the control group were iv administered with Recombinant Human Endostatin Injection, 7.5 mg/m² added into 250 mL normal saline for 1-14 d, once daily. At the same time they were iv administered with Oxaliplatin for injection, 85 mg/m² added into 250 mL normal saline, once every 14 d. Patients in the treatment group were po administered with Huisheng Oral Liquid on the basis of the control group, 10 mL/time, three times daily. A treatment cycle had 21 d, and patients in two groups were treated for 3 cycles. After treatment, the short-term and long-term clinical efficacy was evaluated, and the tumor marker levels, the immune function indicators and adverse reactions in two groups before and after treatment were compared. Results After treatment, the objective reaction rate and clinical benefit rate in the control group were 19.61% and 45.10%, which were significantly lower than 28.85% and 67.31% in the treatment group, respectively, and there were differences between two groups (P < 0.05). After treatment, the duration of disease progression in the treatment group was significantly prolonged, 1 year and 2 year survival rate was significantly higher than that in the control group, with significant difference between two groups (P < 0.05). After treatment, the serum CEA, CA125 and SCCAg levels in two groups were significantly decreased (P < 0.05), and these tumor marker levels in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, CD3⁺, CD4⁺, CD4⁺/CD8⁺ levels in the control group were significantly decreased, and and there were differences in the same group (P < 0.05). After treatment, the serum CD3⁺, CD4⁺, CD4⁺/CD8⁺ levels in the treatment group were significantly higher than that in the control group (P < 0.05). During the treatment, the adverse reactions rate in the control group was 27.45%, which was significantly higher than 9.62% in treatment the group, with significant difference between two groups (P < 0.05). Conclusion Huisheng Oral Liquid combined with recombinant human endostatin and oxaliplatin in treatment of advanced non-small cell lung cancer is effective and safe, which can significantly prolong the survival of patients.

河南省高等学校重点科研项目（16A320045）