西妥昔单抗联合FOLFOX4方案治疗转移性大肠癌的临床研究  

Clinical study on cetuximab combined with FOLFOX4 chemotherapy in treatment of metastatic colorectal cancer

作　　者：胡剑平[1] 毛岸荣[1] 辛海贝[1] 黄河[1] 

机构地区：[1]解放军第八五医院,上海200030

出　　处：《现代药物与临床》2017年第3期500-504,共5页Drugs & Clinic

摘　　要：目的探讨西妥昔单抗注射液联合FOLFOX4方案治疗转移性大肠癌的临床疗效。方法选择2014年6月—2015年12月解放军第八五医院收治的转移性大肠癌患者75例作为研究对象,将全部患者随机分为对照组(37例)和治疗组(38例)。对照组给予FOLFOX4方案治疗:第1天静脉滴注注射用奥沙利铂,85 mg/m^2加入到5%葡萄糖溶液250 m L中;在治疗第1、2天静脉滴注氟尿嘧啶注射液,300 mg/m^2加入到生理盐水250 m L中;在第1、2天静脉滴注亚叶酸钙注射液,400mg/m^2加入到生理盐水250 m L中。治疗组在对照组的基础上静脉滴注西妥昔单抗注射液500 mg/m^2,首次静脉滴注时间>2 h,其后静脉滴注时间>1 h,1次/周。2周为1个疗程,两组患者均治疗4个疗程。观察两组的临床疗效,比较两组的肿瘤标志物水平和不良反应情况。结果治疗后,对照组和治疗组的总有效率分别为40.5%、52.6%,疾病控制率分别为70.3%、89.5%,两组比较差异有统计学意义(P<0.05)。治疗后,两组血清癌胚抗原(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)。对照组和治疗组皮疹总发生率分别为8.11%、34.2%,两组比较差异有统计学意义(P<0.05);但其他不良反应比较差异均无显著性。结论西妥昔单抗注射液联合FOLFOX4方案治疗转移性大肠癌具有较好的临床疗效,可降低肿瘤标志物水平,安全性好,具有一定的临床推广应用价值。Objective To investigate the clinical effect of Cetuximab Solution for infusion combined with FOLFOX4 chemotherapy in treatment of metastatic colorectal cancer.Methods Patients （75 cases） with metastatic colorectal cancer in 85 Hospital of People＇s Liberation Army from June 2014 to December 2015 were randomly divided into the control group （37 cases） and the treatment group （38 cases）. Patients in the control group were treated with FOLFOX4 chemotherapy and iv administered with Oxaliplatin for injection in the first day treatment, 85 mg/m^2 added into normal saline 250 mL. And they were also iv administered with Fluorouracil Injection in the first and second day treatment, 300 mg/m^2 added into normal saline 250 mL. In the same time, patients in the control group were iv administered with Calcium Folinate Injection in the first and second day treatment, 400 mg/m^2 added into normal saline 250 mL. Patients in the treatment group were iv administered with Cetuximab Solution for infusion on the basis of the control group, 500 mg/m^2, intravenous infusion of 2 h at the first time, followed by intravenous infusion of 1 h, once weekly. Patients in two groups were treated for 4 courses, 2 weeks as one course. After treatment, the clinical efficacies were evaluated, and tumor marker levels and adverse reactions in two groups were compared.Results After treatment, the clinical efficacies in the control and treatment groups were 40.5% and 52.6%, respectively, the disease control rates in two groups were 70.3% and 89.5%, respectively, and there was difference between two groups （P 〈 0.05）. After treatment, the levels of CEA and CA199 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）. The total incidence of skin rash in the control and treatment groups were 8.

关 键 词：西妥昔单抗注射液 注射用奥沙利铂 氟尿嘧啶注射液 亚叶酸钙注射液 转移性大肠癌 癌胚抗原 糖类抗原199 

分 类 号：R979.1[医药卫生—药品]