目的 研究参芪扶正注射液联合伊立替康和西妥昔单抗治疗晚期直肠癌的临床疗效和安全性。方法 选取2013年1月-2015年5月武汉市第八医院收治的晚期直肠癌患者80例,随机分为对照组和治疗组,每组各40例。对照组患者在每个化疗周期的第1、8、15天静脉滴注盐酸伊立替康注射液,90 mg/m²,滴注时间30~90 min,同时静脉滴注西妥昔单抗注射液,首次剂量是400 mg/m²,滴注时间大于2 h,然后每周250 mg/m²,滴注时间大于1 h。治疗组在对照组化疗基础上静脉滴注参芪扶正注射液,250 mL/次,1次/d,化疗前3 d开始使用,连续使用14 d。每4周为1个化疗周期。连续治疗2个化疗周期后评定疗效。观察两组的临床疗效,同时比较两组治疗前后CD⁴⁺CD²⁵⁺调节性T细胞、肿瘤坏死因子α(TNF-α)、白介素12(IL-12)及生活质量评分的变化。结果 治疗后,对照组和治疗组的总有效率分别为37.5%、60.0%,两组比较差异具有统计学意义(P < 0.05)。治疗后,对照组CD⁴⁺CD²⁵⁺细胞、IL-12、TNF-α降低,治疗组CD⁴⁺CD²⁵⁺细胞显著降低,IL-12、TNF-α升高,同组治疗前后差异具有统计学意义(P < 0.05);且治疗后,治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P < 0.05)。治疗后,两组心理评分、躯体评分、认知评分、社会评分、角色评分均显著升高,同组治疗前后差异具有统计学意义(P < 0.05);治疗后,治疗组心理评分、躯体评分、认知评分、社会评分均显著高于对照组,两组比较差异具有统计学意义(P < 0.05)。结论 参芪扶正注射液联合伊立替康和西妥昔单抗治疗晚期直肠癌具有较好的临床疗效,可调节患者的免疫功能,提高患者的生活质量,具有一定的临床推广应用价值。

Objective To study the clinical effect and safety of Shenqi Fuzheng Injection combined with irinotecan and cetuximab in treatment of advanced colorectal cancer. Methods Patients (80 cases) with advanced colorectal cancer in Eighth Hospital of Wuhan City from January 2013 to May 2015 were randomly divided into control and treatment groups, and each group had 40 cases. The patients in the control group were iv administered with Irinotecan Hydrochloride Injection on the first, eighth, and fifteenth day of each chemotherapy cycle, 90 mg/m², and drop injection time was 30-90 min. They were iv administered with Cetuximab Solution for infusion with the first dosage of 400 mg/m², and the injection time was more than 2 h. And then the dosage was adjusted to 250 mg/m² per week, and the injection time was more than 1 h. The patients in the treatment group were iv administered with Shenqi Fuzheng Injection on the basis of control group 3 d before chemotherapy, 250 mL/time, once daily, and for 14 d. Every four weeks was as one chemotherapy cycle, and two groups were treated for two cycles. After treatment, the efficacy was evaluated, and the changes of CD4⁺CD25⁺ regulatory T cells, TNF-α, IL-12, and scores of quality life in two groups before and after treatment were compared. Results After treatment, the efficacies in the control and treatment groups were 37.5% and 60.0%, respectively, and there were differences between two groups (P < 0.05). After treatment, CD⁴⁺CD²⁵⁺ cell, IL-12, and TNF-α in the control group reduced, CD⁴⁺CD²⁵⁺ cell significantly reduced in the treatment group, while TNF-α and IL-12 were increased, and the difference was statistically significant in the same group (P < 0.05). The improved degree of those observation indicators in the treatment group was better than those in the control group, with significant difference between two groups (P < 0.05). After treatment, psychological scores, physical scores, cognitive scores, social scores and role scores in two groups were significantly higher, and the difference was statistically significant in the same group (P < 0.05). Psychological scores, physical scores, cognitive scores, and social scores in treatment group were significantly higher than those in the control group, with significant difference between two groups (P < 0.05). Conclusion Shenqi Fuzheng Injection combined with irinotecan and cetuximab has good clinical curative effect in treatment of advanced colorectal cancer, and can adjust the immune function of patients, also can improve the life quality of patients, which has certain clinical application value.