【摘要】 目的：比较分析接受西妥昔单抗联合FOLFOXIRI化疗方案(伊立替康、奥沙利铂、亚叶酸钙、5-Fu)与单纯FOLFOXIRI方案相比，在治疗进展期结肠癌患者中的疗效与安全性。方法：依据治疗方式将86例进展期结肠癌患者随机分为联合用药组(n=50)和单独用药组(n=36),单独用药组患者行根治术前仅接受FOLFOXIRI化疗方案，联合用药组在FOLFOXIRI方案的基础上联合西妥昔单抗治疗，比较两组患者的化疗相关指标、药物不良反应及1、2、3年无病生存期(DFS)和总生存期(OS),采用Kaplan-Merier法进行生存分析。结果：联合用药组患者肿瘤退缩分析(TRG)降级、T级分期降级、N分期降级发生率均优于单独用药组，其差异具有统计学意义(P<0.05),不良反应包括白细胞下降、腹泻、肝肾功能损害、神经系统毒性、口腔黏膜炎症等，差异均无统计学意义(P>0.05),两组患者1、2、3年无病生存率分别为66.1%、15.3%,11.4%和79.2%,49.7%,28.1%,其2、3年DFS差异有显著的统计学意义(P=0.021、P=0.036),两组患者1、2、3年总生存率分别是83.7%、61.0%、15.1%和88.6%、77.2%,38.3%,两组患者的2、3年OS差异具有显著的统计学意义(P=0.031)。结论：与单纯FOLFOXIRI化疗方案相比，西妥昔单抗联合FOLFOXIRI方案治疗进展期结肠癌在肿瘤晚期和延长患者生存期方面具有明显优势，不良反应和相关并发症方面未见明显增加，提高总生存时间方面效果明显。更多还原

【Abstract】 Objective: To compare and analyze the efficacy and safety of the combination therapy of cetuximab with FOLFOXIRI(irinotecan, oxaliplatin, folic acid, 5-FU) versus FOLFOXIRI alone in treating patients with advanced colorectal cancer. Methods: Eighty-six patients were randomly assigned to either the combined treatment group(n=50) or the single treatment group(n=36). The single treatment group received only FOLFOXIRI chemotherapy before radical surgery, while the combined treatment group received FOLFOXIRI therapy combined with cetuximab. Chemotherapy-related indicators, drug adverse reactions, as well as 1-, 2-, and 3-year disease-free survival(DFS) and overall survival(OS) rates were compared between the two groups using Kaplan-Meier analysis. Results: The incidence rates of tumor regression grade(TRG) downgrading, T stage downgrading, and N stage downgrading in the combined treatment group were all significantly better than those in the single treatment group(P<0.05). Adverse reactions including leukopenia, diarrhea, liver and kidney function damage, neurological toxicity, oral mucosal inflammation showed no statistically significant differences between groups(P>0.05). The 1-, 2-, and 3-year DFS rates for both groups were respectively; 66.1%,15.3%,11.4% vs.79.2%,49.7%,28.1%. Differences at year-2 & year-3 DFS were statistically significant(P=0.021,P=0..036), while OS at year-2 and year-3 were found to be significantly different(P=0.031). Conclusion: Compared to sole FOLFOXIRI chemotherapy regimen, the combination of cetuximab with FOLFOXIRI regimen for advanced colorectal cancer patients demonstrated notable advantages in tumor downstaging, promoting patient survival without a marked increase in adverse effects or complications, and had a substantial impact on improving overall survival time.更多还原