参一胶囊联合FL化疗方案对结直肠癌患者的影响

Chemotherapy combined with Chinese medicine Shenyi capsule for patients with colorectal cancer

目的探讨参一胶囊联合FL化疗方案对结直肠癌的疗效。方法选取结直肠癌患者113例随机分为对照组(50例)和治疗组(63例)。对照组使用FL方案化疗配合安慰剂治疗(FL化疗方案:5-FU,425 mg/m2,持续静脉注射,第1-5天;CF,20 mg/m2,静脉注射,第1-5天;28天为1个疗程),治疗组使用参一胶囊(20 mg/次,1天2次,饭前30分钟温开水送服)替换安慰剂治疗。比较两组疗效及不良反应等情况。结果治疗组总有效率和生活质量评分优于对照组,且差异均有统计学意义(均P<0.05)。治疗组不良反应为口咽干燥、口腔溃疡各1例。治疗组治疗周期结束后,T淋巴细胞转化率、CD3、CD4、CD4/CD8均较治疗前有明显提高(均P<0.05);而对照组上述指标均较治疗前下降(均P<0.05)。治疗组术后8周血清中VEGF表达水平低于治疗组术后0周及对照组,且差异均具有统计学意义(均P<0.01)。结论在化疗过程中联合使用参一胶囊治疗结直肠癌,可提高疗效。

Objective To assess the efficacy of chemotherapy combined with Chinese medicine Shenyi capsule for colorectal cancer. Methods One-hundred-and-thirteen patients with colorectal cancer were randomly assigned to receive FL regime（ 5-FU,425 mg / m2,d1-5; CF,20 mg/m2,d1-5; 28 d as a course） with Shenyi capsules（ 20 mg bid）（ study group,n = 63） or FL regime with placebo（ control group,n = 50）. Therapeutic effects and adverse reactions were observed. Results The overall effective rate and score of quality of life in study group were significant higher than those in control group（ both P〈0. 05）. Side effects in study group involved dry mouth and throat（ one case） and oral ulcer（ one case）. After treatment,the rates of CD4,CD3 and T cell conversion and the ratio of CD4 / CD8 were significantly increased in study group（ all P〈0. 05）,while decreased in control group（ all P〈0. 05）. Serum VEGF level at 8 weeks after operation in study group was lower than that in control group,and also lower than that in study group immediately after operation（ both P〈0. 01）. Conclusion Combination of FL chemotherapy with Shenyi capsule can improve the therapeutic efficacy for patients with colorectal cancer.