脾多肽注射液联合FOLFOX4或XELOX治疗Ⅲ/Ⅳ期结肠癌术后患者的疗效及不良反应的比较

Comparative studies of the clinical efficacy and adverse reaction of treating stage Ⅲ/Ⅳ colon cancer with lienal polypeptide injection combined with FOLFOX4 or XELOX

目的:探讨脾多肽联合FOLFOX4或XELOX方案用于Ⅲ/Ⅳ期结肠癌患者术后治疗的疗效及安全性。方法:回顾性收集选择2017年1月至2020年6月期间在广东省惠州市第六人民医院接受晚期结肠癌根治术的患者160例临床资料。将患者分为脾多肽注射液、奥沙利铂、亚叶酸钙联合氟尿嘧啶组[脾多肽+FOLFOX4组(脾F组),n=80]与脾多肽注射液、奥沙利铂联合卡培他滨组[脾多肽+XELOX组(脾X组),n=80],两组患者均于手术后8周开始进行6个疗程的治疗,治疗结束1个月后对两组患者的临床疗效、免疫水平、营养状况、生存质量及不良反应等方面进行为期2年的随访观察。结果:与脾F组相比,脾X组患者的ORR和DCR均显著提高(均P<0.05);CD3^(+)T、CD4^(+)T、NK细胞百分率、EORTC QLQ-C30评分和PNI水平均显著升高(均P<0.05),NLR、LMR、CA125、CA199、CEA均显著下降(均P<0.05)。脾X组患者白细胞或粒细胞减少、神经毒性、口腔黏膜炎和手足综合征等毒性作用和不良反应发生率均明显下降(均P<0.05)。两组患者2年PFS和OS无明显差异(均P>0.05)。结论:在Ⅲ/Ⅳ期结肠癌术后患者的治疗中,脾多肽注射液联合XELOX方案比联合FOLFOX4方案在改善不良反应发生率和生活质量方面具有明显优势。

Objective: To examine the efficacy and safety of lienal polypeptide injection combined with FOLFOX4 or XELOX in the treatment of stage Ⅲ/Ⅳ colon cancer. Methods: One hundred and sixty patients who underwent a curative resection of colon cancer in the Sixth People’s Hospital of Huizhou between January 2017 and June 2020 were included in the study. All patients were randomized into 2 groups of 80 each: patients who received lienal polypeptide injection combined with FOLFOX4(lienal polypeptide+FOLFOX4group) and patients who received lienal polypeptide injection combined with XELOX(lienal polypeptide + XELOX group). All patients were given six rounds of treatment. Two-year follow-up assessments of the clinical efficacy, immunity, nutritional status,quality of life and toxicity or adverse effects were conducted 1 months after the end of treatment. Results: Compared with the lienal polypeptide+FOLFOX4 group, the disease control rate(DCR) and objective response rate(ORR) of the lienal polypeptide+XELOX group were dramatically improved(all P<0.05). The percentage of CD3^(+)T cells, CD4^(+)T cells and NK cells, the EORTC QLQ-C30 scores and the level of PNI in the lienal polypeptide+XELOX group were higher(all P<0.05). NLR, LMR, CA125, CA199, and CEA were significantly decreased(all P<0.05). In terms of adverse effects, the incidence of leukopenia, neutropenia, neurotoxicity, oral mucositis, and hand foot syndrome in the lienal polypeptide + XELOX group were remarkably decreased compared with the lienal polypeptide + FOLFOX4 group(all P<0.05). No difference in progression-free survival(PFS) and overall survival(OS) was detectable(all P>0.05). Conclusion: Compared with lienal polypeptide injection combined with FOLFOX4, lienal polypeptide injection combined with XELOX has a significant advantage in decreasing the incidence of adverse events and improving the quality of life of Ⅲ/Ⅳ colon cancer patients.