目的 探讨重组人血管内皮抑制素注射液联合西妥昔单抗注射液和FOLFIRI方案治疗晚期结直肠癌的临床疗效。方法 选取2014年3月-2016年3月天津市公安医院收治的晚期结直肠癌化疗患者的80例，随机分为对照组和治疗组，每组各40例。对照组静脉滴注西妥昔单抗注射液，首次剂量400 mg/m²，维持剂量250 mg/m²；并在西妥昔单抗治疗结束后60 min开始进行FOLFIRI方案：治疗第1天静脉滴注盐酸伊立替康注射液，180 mg/m²加入到生理盐水250 mL中；治疗第1、2天静脉滴注亚叶酸钙注射液，200 mg/m²加入到生理盐水250 mL中；治疗第1天静脉推注氟尿嘧啶注射液，400 mg/m²，然后2 400 mg/m²持续静脉泵入。治疗组在对照组基础上静脉滴注重组人血管内皮抑制素注射液，15 mg加入到生理盐水500 mL中，连续治疗10 d。两组患者均以2周为1个疗程，治疗4个疗程。观察两组的临床疗效，比较两组的免疫功能和肿瘤标志物水平情况。结果 治疗后，对照组和治疗组的客观反应率（ORR）分别为45.0%、67.5%，疾病控制率（DCR）分别为85.0%、92.5%，两组比较差异有统计学意义（P<0.05）。治疗后，两组CD⁴⁺、CD⁴⁺/CD⁸⁺均显著升高，而CD⁸⁺均显著下降，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些观察指标的改善程度明显优于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组癌胚抗原（CEA）、糖类抗原199（CA199）水平均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组这些观察指标的下降程度明显优于对照组，两组比较差异具有统计学意义（P<0.05）。两组无进展生存期（PFS）、总生存期（OS）和不良反应发生率比较差异无统计学意义。结论 重组人血管内皮抑制素注射液联合西妥昔单抗注射液和FOLFIRI方案治疗晚期结直肠癌具有较好的临床疗效，可改善免疫功能，降低肿瘤标志物水平，具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Recombinant Human Endostatin Injection combined with Cetuximab Solution for infusion and FOLFIRI chemotherapy in treatment of advanced colorectal cancer. Methods Patients (80 cases) with advanced colorectal cancer in Tianjin Public Security Hospital from March 2014 to March 2016 were randomly divided into control and treatment groups, and each group had 40 cases. Patients in the control group were iv administered with Cetuximab Solution for infusion, the first dose of 400 mg/m², maintenance dose of 250 mg/m², once daily. The FOLFIRI chemotherapy started after the end of cetuximab treatment for 60 min. Patients in the control group were iv administered with Irinotecan Hydrochloride Injection in the first day treatment, 180 mg/m² added into normal saline 250 mL; and were iv administered with Calcium Folinate Injection in the first and second day treatment, 200 mg/m² added into normal saline 250 mL. In the same time, they were also iv administered with Fluorouracil Injection in the first day treatment, 400 mg/m², then 2 400 mg/m² continuous intravenous infusion. Patients in the treatment group were iv administered with Recombinant Human Endostatin Injection on the basis of the control group, 15 mg added into normal saline 500 mL, continuous treatment of 10 d. Patients in two groups were treated for 4 courses, 2 weeks as one course. After treatment, the clinical efficacies were evaluated, and immune function and tumor marker levels in two groups were compared. Results After treatment, the ORR in the control and treatment groups were 45.0% and 67.5%, respectively, and the DCR in the control and treatment groups were 85.0% and 92.5%, respectively, and there was difference between two groups (P<0.05). After treatment, CD⁴⁺ and CD⁴⁺/CD⁸⁺ in two groups were significantly increased, but the CD⁸⁺ in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups (P<0.05). After treatment, CEA and CA199 levels in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). There were no difference of PFS, OS and adverse reaction rates between two groups. Conclusion Recombinant Human Endostatin Injection combined with Cetuximab Solution for infusion and FOLFIRI chemotherapy has clinical curative effect in treatment of advanced colorectal cancer, can improve immune function, and decrease tumor marker levels, which has a certain clinical application value.