中医辨证维持治疗晚期结直肠癌的临床研究

目的评价中医辨证在晚期结直肠癌维持期的疗效。方法将符合晚期结直肠癌维持治疗诊断标准的120例患者随机分为中药组60例和卡培他滨组各60例。卡培他滨组按照每日总剂量（常规用量每日2000mg／m2）分早晚各1次饭后0．5h吞服，连用2周间隔1周。中药组以“证素”为基础，参考《大肠癌病证规律及中医证素诊疗规范化探讨》进行中医辨证汤剂治疗。2组均持续用药至肿瘤进展或出现无法耐受的不良反应为止。结果中药组的中位无疾病进展时间（PFS）为5．4个月，卡培他滨组中位PFS为2个月，2组比较差异有统计学意义（P=0．021〈0．05）；与卡培他滨组比较，中药组可以明显提高晚期结直肠癌患者的NK细胞及CD4／CD8（P〈0．05），可以明显改善患者的卡氏评分（P〈0．01）。结论中医辨证维持治疗具有延长患者PFS、改善免疫功能、提高生活质量的作用。

Clinical study of maintenance treatment with TCM syndrome differentiation on advanced colorectal cancer

Objective To evaluate the efficacy of TCM syndrome differentiation for the maintenance therapy in patients with advanced colorectal cancer. Methods 120 patients who met the diagnostic criteria for maintenance treatment of advanced colorectal cancer, were randomly divided into a TCM group and a capecitabine group, 60 patients in each group. The capecitabine group was taken oral administration （ normal dosage 2000 mg/m2 daily） 0. 5 h after meals one in the morning and one in the evening for continuous two weeks then for one-week interval. The TCM group was referred to Discussion on the Disease-Syndrome Rules and Standardization of TCM Elements Diagnosis-Treatment in Colorectal Cancer for the TCM syndrome differentiation in the basis of syndrome elements. The two groups continued to take medicine till cancer progression or side effects beyond sufferance. Results The median progression free survival （PFS） in the TCM group was 5.4 months, while in the capecitabine group was 2 months, which had significant difference （P = 0. 021 〈0. 05） ; Compare with the capecitabine group, the TCM group could apparently improve NK cells and CD4/CD8 （P 〈0. 05）, as well as the patients＇ Karnofsky performance score （ P 〈 0. 01 ）. Conclusion The maintenance therapy by TCM syndrome differentiation in patients with advanced colorectal cancer can effectively prolong the PFS, improve immune function and enhance the quality of life.