目的 探討重組人血管內(nèi)皮抑制素注射液聯(lián)合西妥昔單抗注射液和FOLFIRI方案治療晚期結(jié)直腸癌的臨床療效。方法 選取2014年3月-2016年3月天津市公安醫(yī)院收治的晚期結(jié)直腸癌化療患者的80例，隨機分為對照組和治療組，每組各40例。對照組靜脈滴注西妥昔單抗注射液，首次劑量400 mg/m²，維持劑量250 mg/m²；并在西妥昔單抗治療結(jié)束后60 min開始進行FOLFIRI方案：治療第1天靜脈滴注鹽酸伊立替康注射液，180 mg/m²加入到生理鹽水250 mL中；治療第1、2天靜脈滴注亞葉酸鈣注射液，200 mg/m²加入到生理鹽水250 mL中；治療第1天靜脈推注氟尿嘧啶注射液，400 mg/m²，然后2 400 mg/m²持續(xù)靜脈泵入。治療組在對照組基礎(chǔ)上靜脈滴注重組人血管內(nèi)皮抑制素注射液，15 mg加入到生理鹽水500 mL中，連續(xù)治療10 d。兩組患者均以2周為1個療程，治療4個療程。觀察兩組的臨床療效，比較兩組的免疫功能和腫瘤標志物水平情況。結(jié)果 治療后，對照組和治療組的客觀反應(yīng)率（ORR）分別為45.0%、67.5%，疾病控制率（DCR）分別為85.0%、92.5%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05）。治療后，兩組CD⁴⁺、CD⁴⁺/CD⁸⁺均顯著升高，而CD⁸⁺均顯著下降，同組治療前后比較差異有統(tǒng)計學(xué)意義（P<0.05）；且治療組這些觀察指標的改善程度明顯優(yōu)于對照組，兩組比較差異具有統(tǒng)計學(xué)意義（P<0.05）。治療后，兩組癌胚抗原（CEA）、糖類抗原199（CA199）水平均顯著降低，同組治療前后比較差異有統(tǒng)計學(xué)意義（P<0.05）；且治療組這些觀察指標的下降程度明顯優(yōu)于對照組，兩組比較差異具有統(tǒng)計學(xué)意義（P<0.05）。兩組無進展生存期（PFS）、總生存期（OS）和不良反應(yīng)發(fā)生率比較差異無統(tǒng)計學(xué)意義。結(jié)論 重組人血管內(nèi)皮抑制素注射液聯(lián)合西妥昔單抗注射液和FOLFIRI方案治療晚期結(jié)直腸癌具有較好的臨床療效，可改善免疫功能，降低腫瘤標志物水平，具有一定的臨床推廣應(yīng)用價值。

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.