目的 观察参附注射液联合FOLFOX4方案治疗直肠癌的临床研究。方法 选取武警上海市总队医院2014年5月-2016年6月收治的直肠癌患者120例作为研究对象，采用随机数字表法将患者分为对照组和治疗组，每组各60例。对照组采用FOLFOX4方案治疗；治疗组在对照组的基础上，静脉滴注参附注射液，30～60 mL加入5%葡萄糖注射液250 mL，1次/d，连续10 d，最长20 d。从治疗开始，两组均观察1个月。观察两组的临床疗效，比较两组生活质量评分、营养指标、血清免疫指标和毒副作用。结果 治疗后，对照组、治疗组疾病控制率分别为88.33%、95.00%，两组疾病控制率比较差异具有统计学意义（P<0.05）。治疗后，对照组、治疗组卡氏（KPS）评分提高率分别为41.67%、58.33%，两组KPS评分提高率比较差异具有统计学意义（P<0.05）。治疗后，两组患者白蛋白（ALB）、前白蛋白（PA）、总蛋白（TP）、转铁蛋白（TF）水平以及IgG、IgA、IgM水平和总淋巴细胞计数（TLC）均明显降低，与同组治疗前比较差异有统计学意义（P<0.05）；且治疗组这些观察指标比对照组降低得更明显（P<0.05）。治疗组不良反应发生率均低于对照组，两组不良反应发生率比较差异具有统计学意义（P<0.05）。结论 参附注射液联合FOLFOX4方案治疗直肠癌疗效显著，可明显改善临床疗效，提高患者生活质量，改善营养指标和血清免疫指标，减轻毒副作用，具有一定的临床推广应用价值。

Objective To observe the clinical curative effect of Shenfu Injection combined with FOLFOX4 regimen in treatment of rectal cancer. Methods Patients (120 cases) with rectal cancer in Shanghai Armed Police Corps Hospital from May 2014 to June 2016 were enrolled in this study. According to the random number table, patients were divided into the control group and treatment group, and each group had 60 cases. Patients in the control group were treated with FOLFOX4 regimen. Patients in the treatment group were iv administered with Shenfu Injection on the basis of the control group, 30-60 mL added into 5% glucose Injection 250 mL, once daily, lasted for 10-20 d. Patients in two groups were observed for one month. After treatment, the efficacy was evaluated, and quality of life, nutritional indexes, serum immune indexes, and adverse reactions in two groups were compared. Results After treatment, disease control rates in the control and treatment groups were 88.33% and 95.00%, respectively, and there were differences between two groups (P<0.05). Improvement rates of KPS score in the control and treatment groups were 41.67% and 58.33%, respectively, and there were differences between two groups (P<0.05). After treatment, levels of ALB, PA, TP, TF, IgG, IgA, IgM, and TLC in two groups were significantly decreased (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group (P<0.05). Compared with the control group, adverse reaction rates in the treatment group were lower than those in the treatment group, with significant difference between two groups (P<0.05). Conclusion Shenfu Injection combined with FOLFOX4 regimen have clinical curative effect in treatment of rectal cancer, can obviously improve the clinical symptoms, improve the quality of life, improve nutritional index and serum immune index, reduce adverse reactions, which has a certain clinical application value.