健脾解毒方治疗脾虚湿热型晚期大肠癌的临床疗效评价

目的:评价健脾解毒方对脾虚湿热型晚期大肠癌患者的临床疗效。方法:共选90例化疗失败的脾虚湿热型晚期大肠癌患者,随机分为治疗组和对照组,每组各45例。在常规对症支持治疗的基础上,治疗组服用健脾解毒方煎剂,对照组服用复方斑蝥胶囊,连续治疗6个月。观察健脾解毒方对总生存期(overall survival,OS)、中医证候及细胞免疫功能的影响。结果:共有84例患者完成试验,其中治疗组43例、对照组41例。治疗组的中位OS为102 d(95%CI:95.6~108.4 d),对照组中位OS为80 d(95%CI:76.1~83.9d),治疗组较对照组显著延长(P0.01);治疗组中医证候疗效显著改善15例、部分改善17例、无改善11例,对照组中显著改善9例、部分改善10例、无改善22例,治疗组的证候改善率明显优于对照组(P0.05);治疗组治疗后CD4+、CD4+/CD8+水平均显著高于对照组(P0.01)。结论:健脾解毒方可以延长化疗失败的晚期大肠癌患者生存期,改善临床症状,提高生活质量,提高细胞免疫功能。

Clinical Efficacy Evaluation of Jianpi Jiedu Recipe in the Treatment of Advanced Colorectal Cancer with Syndrome of Dampness-heat Due to Spleen Deficiency

  Objective:To evaluate the clinical efficacy of Jianpi Jiedu Recipe on patients of advanced colorectal cancer with syndrome of dampness-heat due to spleen deficiency.   Methods: A total of 90 patients of advanced colorectal cancer with syndrome of dampness-heat due to spleen deficiency who failed to chemotherapy were randomly divided into the treatment group and control group,45 cases in each group. Based on the routine symptomatic supportive treatment,the patients in the treatment group were treated with the decoction of Jianpi Jiedu Recipe,the control group was treated with compound cantharis capsules,with a course of continuous 6 months. The effects of Jianpi Jiedu Recipe on the overall survival(OS),Chinese medical syndrome and cellular immune function were observed.   Results: A total of 84 patients completed the trial,including 43 cases in the treatment group and 41 cases in the control group. The median OS of the treatment group was 102 days (95%CI:95.6-108.4 days),and the median OS of the control group was 80 days (95%CI:76.1-83.9 days). The median OS of the treatment group was significantly prolonged compared with the control group(P<0.01). For the Chinese medical syndrome,there were 15 cases with significant improvement,17 cases with partial improvement and 11 cases with no improvement in the treatment group. In the control group,there were 9 cases with significant improvement,10 cases with partial improvement and 22 cases with no improvement. The improvement rate on syndrome in the treatment group was obviously better than that in the control group(P<0.05). After treatment,the levels of CD4⁺ and CD4⁺/CD8⁺ ratio in the treatment group were significantly higher than those in the control group(P<0.01).   Conclusion: Jianpi Jiedu Recipe can prolong the survival time of patients with advanced colorectal cancer after chemotherapy failure,improve the clinical symptoms and enhance the quality of life,and increase the cellular immune function.