参一胶囊联合卡培他滨维持治疗晚期大肠癌的临床研究

目的评价参一胶囊联合卡培他滨维持治疗晚期大肠癌的疗效和安全性。方法对61例经过一线治疗后达到完全缓解、部分缓解或稳定的晚期大肠癌患者,采用随机分组的方法进行维持治疗。其中试验组（30例）应用参一胶囊联合卡培他滨维持治疗,对照组（31例）单用卡培他滨维持治疗。结果试验组和对照组的中位无进展生存期（PFS）分别为10.0个月和8.0个月,试验组无疾病进展生存状况显著优于对照组（P=0.003）。试验组骨髓抑制发生率显著低于对照组（P〈0.05）。结论对于晚期大肠癌患者,参一胶囊联合卡培他滨维持治疗对比单用卡培他滨维持治疗能延长患者的PFS,减少骨髓抑制的发生。

Clinical study of Shen Yi capsule combined with capecitabine in maintenance treatment of advanced colorectal cancer

Objective To observe the clinical effect and safety of Shen Yi capsule plus capecitabine in the maintenance treatment of advanced colorectal cancer. Method Sixty-one patients of advanced colorectal cancer after firstline chemotherapy with CRPR and SD were randomized into experiment group administered with Shen Yi capsule and capecitabine（30 cases） or control group receiving capecitabine alone（31 cases）. Result The median PFS was10.0 months in experiment group and 8.0 months in control group, and there was significant difference in between（P=0.003）. Bone marrow suppression rate of experiment group was significantly less than that of control group（P 0.05）. Conclusion The combination of Shen Yi capsule and capecitabine can prolong PFS of patients, as well as reduce bone marrow suppression in advanced colorectal cancer when given in maintenance treatment.