复方斑鳌胶囊联合FOLFOX6方案治疗老年结肠癌肝转移的临床研究

Clinical study on Compound Banmao Capsules combined with FOLFOX6 chemotherapy in treatment of elderly hepatic metastasis of colonic carcinoma

目的探讨复方斑鳌胶囊联合FOLFOX6方案治疗老年结肠癌肝转移的临床疗效。方法将延安大学附属医院2011年11月—2013年11月接受治疗的老年结肠癌肝转移患者98例,随机分为对照组和治疗组,每组各49例,对照组患者给予FOLFOX6方案进行化疗:氟尿嘧啶注射液2 800 mg/m^2持续泵入46 h,第1天静脉滴注亚叶酸钙注射液400 mg/m^2;第1天静脉滴注注射用奥沙利铂85 mg/m^2,2周为1个疗程。治疗组患者在对照组的基础上口服复方斑鳌胶囊,3粒/次,2次/d。两组均治疗3个月。治疗后对患者进行为期3年的随访,观察两组的临床疗效,比较两组的免疫功能指标和不良反应情况。结果治疗后,对照组的客观缓解率和疾病控制率分别为36.7%、77.5%;治疗组的分别为46.9%、89.7%;两组客观缓解率和疾病控制率比较差异具有统计学意义(P<0.05)。治疗组1、2、3年的生存率分别为95.9%、87.7%、63.2%,均显著高于对照组的83.6%、65.3%、46.9%,两组比较差异均具有统计学意义(P<0.05)。治疗组的腹泻腹痛、恶心呕吐、白细胞计数下降、周围神经病变和皮疹的不良反应发生率均明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论复方斑鳌胶囊联合FOLFOX6方案治疗老年结肠癌肝转移患者疗效确切,能够有效提高患者免疫功能,且不良反应小,具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Compound Banmao Capsules combined with FOLFOX6 chemotherapy in treatment of elderly hepatic metastasis of colonic carcinoma.Methods Elderly patients （98 cases） with hepatic metastasis of colonic carcinoma in Yan＆#39;an University Affiliated Hospital from November 2011 to November 2013 were randomly divided into control and treatment groups, and each group had 49 cases. The patients in the control group were treated by FOLFOX6 chemotherapy. The patients in the control group were pumped with Fluorouracil Injection for 46 h, 2800 mg/m2. They were iv administered with Calcium Folinate Injection in the first day, 400 mg/m2. And they were also iv administered with Oxaliplatin for injection, 85 mg/m2. Two weeks were one course. The patients in the treatment group werepo administered with Compound Banmao Capsules, 3 grains/time, twice daily. Two groups were treated for 3 months. They were followed-up for 3 years after treatment. The efficacy was evaluated, and the immune function indexes and adverse reactions in two groups were compared.Results After treatment, the objective response rate and disease control rate of control group were 36.7% and 77.5%, while those index of treatment group were 46.9% and 89.7%, and there were differences between two groups （P 〈 0.05）. Survival rate of 1, 2, and 3 years in the treatment （95.9%, 87.7%, and 63.2%） were higher than those in control group （83.6%, 65.3%, and 46.9%） with significant difference （P 〈 0.05）. The incidences of diarrhea and stomachache, nausea and vomiting, leucopenia, peripheral neuropathy, and rash in treatment group were significantly lower than those in the control group, and the differences were statistically significant between two groups （P〈 0.05）. Conclusion Compound Banmao Capsules combined with FOLFOX6 chemotherapy has a good effect in treatment of elderly hepatic metastasis of colonic carcinoma, can promote the immune function with less adverse reactions, which has a certain clinical application value.