平消胶囊联合FOLFOX4方案治疗大肠癌的临床研究

Clinical study of Pingxiao Capsules combined with FOLFOX4 scheme in treatment of colorectal cancer

目的：观察平消胶囊联合FOLFOX4化疗方案对大肠癌患者术后临床疗效、生活质量及免疫功能的影响。方法选取襄阳市中心医院2013年6月—2014年12月大肠癌病例96例，随机分为治疗组（48例）和对照组（48例）。对照组给予FOLFOX4方案化疗，注射用奥沙利铂130 mg/m2，1次/d，持续静脉滴注，3 h内滴完，第1天；注射用亚叶酸钙100 mg/m2，1次/d，静脉滴注，第1～5天；氟尿嘧啶注射液600 mg/m2，1次/d，静脉滴注，24 h持续滴注，或至少6 h以上滴完，第1～5天。治疗组给予FOLFOX4方案化疗，并于化疗第1天开始给予平消胶囊8粒/次，3次/d。3周为1个疗程，连续观察4个疗程。比较两组患者的临床疗效、生活质量、体质量、免疫功能和毒副反应。结果治疗组有效率为91.67%，对照组有效率为79.17%，两组有效率比较差异具有统计学意义（P＜0.05）。治疗组KPS评分改善率为87.50%，对照组KPS评分改善率为70.85%，两组KPS评分改善率比较差异具有统计学意义（P＜0.05）。治疗组体质量改善率为91.7%，对照组体质量改善率为62.5%，两组体质量改善率比较差异具有统计学意义（P＜0.05）。治疗后治疗组CD3＋、CD4＋、CD4＋/CD8＋、NK细胞明显升高，CD8＋明显降低，与治疗前比较差异具有统计学意义（P＜0.05、0.01），与对照组治疗后比较差异具有统计学意义（P＜0.05）。治疗后治疗组IgG、IgM水平较治疗前明显升高（P＜0.01），与对照组比较差异具有统计学意义（P＜0.05）。结论平消胶囊联合FOLFOX4方案化疗对大肠癌术后患者的生活质量、体质量变化疗效均明显优于单纯化疗，可显著增强患者术后早期机体免疫功能，提高生活质量，有很好的临床应用价值。

Objective To observe the impact of Pingxiao Capsules combined with FOLFOX4 scheme on clinical efficacy, quality of life, and immune function among patients with colorectal cancer after operation.Methods The 96 cases of colorectal cancer patients admitted to Xiangyang Central Hospital from June 2014 to December 2013 were randomly divided into the control group and the treatment group, and each group had 48 cases. The control group was treated with FOLFOX4 scheme （including oxaliplatin,Calcium folic acid, and fluorouracil） conventional chemotherapy. The patients in the control group were iv administered with Oxaliplatin for injection 130 mg/m2, once daily, intravenous dripping within 3 h in the first day. And then they were iv administered with Calcium folic acid for injection 100 mg/m2, once daily, intravenous dripping from the first day to the fifth day. Finally Fluorouracil Injection was iv administered 600 mg/m2, once a day, continuous intravenous drip for 24 h continuous infusion, or at least more than 6 h drops, from first day to fifth day. The treatment group was given Pingxiao Capsules at the basis of chemotherapy for the first day, 8 capsules / time, three times daily. One course of treatment was 3 weeks. After four courses of treatment, changes in efficacy, quality of life, weight change, immune function, and toxicity in two groups were compared.Results After treatment, the efficacies in the treatment and control groups were 91.67% and 79.17%, respectively, and there were differences between two groups （P〈 0.05）. The KPS score improvement rates of the treatment and control groups were 87.50% and 70.85%, respectively, and the differences were statisticallysignificant between two groups （P〈 0.05）. The body weight improvement rates of the treatment and control groups were 91.7% and 62.5%, respectively, with significant differences between two groups （P〈 0.05）. After treatment, CD3＋, CD4＋, CD4＋/CD8＋, and NK cells were significantly increased, but CD8＋ in two groups significantly reduced, and the difference was statistically significant in the same group （P 〈 0.05, 0.01）. Compared with the control group, these indicators in treatment group improved better, with significant differences between two groups （P 〈 0.05）. After treatment, the levels of IgG and IgM were significantly increased, and the difference was statistically significant in the same group （P 〈 0.01）. And these indicators in treatment group improved better than those in the control group, with significant differences between two groups （P 〈 0.05）.Conclusion Pingxiao Capsules combined with the chemotherapy of FOLFOX scheme for patients with colorectal cancer after operation is significantly better than patients treated with chemotherapy in enhancing early immune function of colorectal cancer patients undergoing postoperative chemotherapy, improving quality of life, which has a good clinical value.