养正消积胶囊联合FOLFIRI方案治疗结直肠癌的临床研究

Clinical study on Yangzheng Xiaoji Capsules combined with FOLFIRI scheme in treatment of colorectal cancer

目的观察养正消积胶囊联合FOLFIRI方案治疗结直肠癌的临床效果。方法选取2013年4月—2015年3月于陕西省肿瘤医院接受过手术治疗的84例结直肠癌患者,按就诊及入院顺序编号,以随机数字表法分为对照组和治疗组,每组各42例。对照组采用FOLFIRI化疗方案,治疗组在对照组基础上口服养正消积胶囊,4粒/次,3次/d。两组患者均连续治疗2个疗程。观察两组患者的临床疗效,比较两组治疗前后T细胞亚群(CD^(3+)、CD^(4+)、CD^(8+))及NK细胞活性的变化,考察毒副反应情况和生活质量的改善情况。结果治疗后,对照组和治疗组的总有效率分别为61.90%、85.71%,两组总有效率比较差异具有统计学意义(P<0.05)。治疗后,治疗组CD^(3+)、CD^(4+)和NK细胞活性明显上升,CD8+活性降低,同组治疗前后差异具有统计学意义(P<0.05);且治疗组这些观察指标的改善程度明显优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组骨髓抑制、便秘发生率分别为2.38%、4.76%,均低于对照组(P<0.05),其恶心/呕吐、肝肾功能异常、腹泻、黏膜炎发生率均略低于对照组,但差异无统计学意义。治疗后,治疗组KPS评分明显升高,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组KPS评分的上升幅度明显高于对照组,两组比较差异具有统计学意义(P<0.05)。结论养正消积胶囊联合FOLFIRI化疗方案治疗结直肠癌具有较好的临床疗效,强化患者免疫抵抗力,改善生活质量,提高治疗的安全性,具有一定的临床推广应用价值。

Objective To observe the clinical efficacy of Yangzheng Xiaoji Capsules combined with FOLFIRI scheme in treatment of colorectal cancer. Methods Patients（84 cases） with colorectal cancer who received surgical treatment in Shaanxi Provincial Tumor Hospital from April 2013 to March 2015 were numbered according to the order of registration and admission, and divided into the control group and treatment group according to the random number table method, and each group had 42 cases. The patients in the control group were treated by FOLFIRI chemotherapy scheme. The patients in the treatment group were po administered with Yangzheng Xiaoji Capsules, 4 capsules/time, three times daily. The patients in two groups were treated for two courses. After treatment, the clinical efficacies were evaluated, and the changes of T lymphocyte subsets（CD^（3＋）, CD^（4＋）, and CD^（8＋）） and NK cell activity were compared between the two groups. In the same time, incidence of adverse reactions and improvement of quality of life between two groups were analyzed. Results After treatment, the clinical efficacies in the control and treatment groups were 61.90% and 85.71%, respectively, and there was difference between two groups（P〈 0.05）. After treatment, CD^（3＋）, CD^（4＋） and NK activity of the treatment group were significantly increased, while CD^（8＋） activity was decrease, and the difference was statistically significant in the same group（P〈 0.05）. And those immune function indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈 0.05）. After treatment, the incidence rates of myelosuppression and constipation in the treatment group were 2.38% and 4.76%, and lower than those in the control group（P〈 0.05）. The incidence rates of nausea/vomiting, hepatorenal dysfunction, diarrhea, and mucosal inflammation were slightly lower than those in the control group, but the differences were not statistically significant. After treatment, KPS score in the treatment group were significantly increased, and the difference was statistically significant in the same group（P〈 0.05）. After treatment, the rise ranges in the treatment group higher than those in the control group, with significant difference between two groups（P〈 0.05）. Conclusion Yangzheng Xiaoji Capsules combined with FOLFIRI scheme has clinical curative effect in the treatment of colorectal cancer, can strengthen immunity, improve the quality of life of patients, is less adverse reactions, which has a certain clinical application value.