康力欣胶囊联合辨证中药维持治疗晚期结直肠癌的临床观察

Clinical Study of Kanglixin Capsule Combined with Differentiated Chinese Medicine in Maintenance of Advanced Colorectal Cancer

目的:评价康力欣胶囊联合辨证中药维持治疗晚期结直肠癌的疗效和安全性。方法:对69例经过一线标准治疗后达到完全缓解、部分缓解或稳定的晚期转移性结直肠癌患者,采用区组随机化方法,将符合标准患者按1∶1比例分为治疗组与对照组,其中治疗组(35例)应用康力欣胶囊联合辨证中药维持治疗,对照组(34例)单用辨证中药维持治疗,观察患者无进展生存期及生活质量变化。结果:治疗组和对照组的中位无疾病进展生存期(Progression Free Survival,PFS)分别为7个月和5个月,治疗组无疾病进展生存时间优于对照组(P=0.023)。结论:对于晚期结直肠癌患者,康力欣胶囊维持治疗能延长患者PFS,辨证中药联合康力欣胶囊口服可作为晚期结直肠癌维持治疗选择之一。

Objective：To observe the clinical effect and safety of Kanglixin capsule combined with differentiated Chinese medicine in the maintenance of advanced colorectal cancer.Methods：Sixty-nine patients of advanced colorectal cancer with a response evaluation of CR, PR or SD after first-line chemotherapies were randomized into two groups.Patients in experiment group, 35 cases, were administered with Kanglixinin capsule combined with differentiated Chinese medicine, and those in control group, 34 caese, were administered with differentiated Chinese medicine only.Results：The median PFS was 7 months in the experiment group and 5 months in the control group, and there was significant difference （P=0.023）.Conclusion：Kanglixin capsule can prolong PFS of patients and is a good choice in the maintenance of advanced colorectal cancer.