Clinical Observation Of Qingrelishijiedu Therapy Combined With XELOX Chemotherapy On Advanced Colorectal Cancer Of Damp-Heat And Amassing Poison-Type

Objectives:This work is dedicated to investigate the clinical effect and safety of self-made Qingrejiedulishi therapy combined with XELOX treatment on the survival condition of advanced colorectal cancer patients(of damp-heat and amassing poison syndrome), to supplement the theoretical basis of the combined treatment of TCM and chemotherapy.Methods:The object of study are advanced colorectal cancer patients who were treated at the tumor hospital which is affiliated to Harbin Medical University, and accepted TCM therapy in the first affiliated hospital of Heilongjiang University of Chinese Medicine from November of 2012 to November of 2013. Based on randomized-controlled method, placebo-controlledtrial and selection criteria,80 cases in total of advanced colorectal cancer patients were chosen and arranged into two groups, notified by study group and control group. Basic treatment for both 2 groups is Capecitabine combined with Oxaliplatin for 6 weeks. The study group(A group) were additionally treated with Qingrejiedulishi therapy with 150ml, b.i.d. during the treatment period, however, the control group(B group) with placebo (Brown sugar water) with same dose. No extra anticancer drugs except necessary supportive treatment were used on both groups.The adverse reaction of visit to viewis due to be at the end of each chemotherapy cycle, and the efficiency of visit to view at the end of each 2 cycles of chemotherapy. The difference of clinical efficacy andtime-effect between two groups (according to the RECIST, e.g., response evaluation criteria in solid tumors), the KPS scores and the TCM Syndrome scores were evaluated and compared between the two groups both before and after corresponding treatments.Results:1. Baseline Data:The baseline data consisting of Gender index, cancer duration and pre-treatment, etc. has no statistically significant meaning(P>0.05) for two groups.2. Chemotherapy completion rate:Two groups after 2 and 6 cycles of chemotherapy, showing no statistically significant difference (P>0.05).; after 4 cycles,showingstatistically significant difference (P<0.05).3. Objective curative effects in solid tumors:The disease response rate and control rate for both A and B groups showed no statistically significant difference (P>0.05).4. TCM syndromes:The curative effect of group A superior to group B in the aspect of improvement of TCM syndromes, showing statistically significant difference (P<0.05); The TCM syndromescores were largely improved than before.5. KPS score:KPS scores of both groups weresignificantly changed, meanwhile A group got higher score than B group.Data showed statistically significant difference of the two group after the treatment period(P<0.05).6. Serum tumor markers detection:both CEA and CA199 drastically changed after treatment period, giving no statistically significant difference(P>0.05).7. The incidence of adverse reactions:The two groups showed that difference of the adverse reactions was statistically not significant(P>0.05).Conclusion:1. The combined treatment of self-made Qingrejiedulishi therapycombined and XELOX chemotherapy will reduce the tumor solids, help relieving TCM syndromes, improve the KPS scoring of the advanced colorectal cancer patients, showing better clinical efficacy than chemotherapy alone.2. The self-made Qingrejiedulishi therapycan relieve the adverse effects induced by chemotherapysignificantly; increase the completion of chemotherapy which is also is shown to be superior to the control group.