| Objective:The purpose of this study was to observe the clinical efficacy of Yiyi Fuzi Baijiang San combined with XELOX chemotherapy regimen in the treatment of stage IV colorectal cancer patients(cold-heat mixed syndrome).Methods:In this study,patients were randomly divided into an observation group and a control group.The control group was given XELOX chemotherapy regimen for 2 cycles.An additional Chinese medicine prescription was taken orally for 42 consecutive days in the observation group.The curative effect was evaluated according to the shortterm objective effects,TCM symptoms scores,tumor markers,quality of life scores,and fecal occult blood test results.We also analyzed the adverse reactions.Results:A total of 76 cases were included in this study,38 cases in each group.During the course of the study,two cases of each group fell off,and a total of 72 valid cases were obtained.1.Comparison of short-term objective curative effects of tumors: The treatment effectiveness rates of the two groups were 16.67%(observation group)and 19.44%(control group),and the disease control rates were 91.67%(observation group)and 80.56%(control group).A statistical comparison of the two rates in two groups both showed P>0.05,so the difference was not statistically significant;2.Comparison of TCM symptoms scores: In this study,all TCM symptoms scores in the observation group were significantly lower after treatment(P<0.05),while the scores in the control group were significantly lower only in terms of abdominal pain,bloating,stool with pus and blood,and constipation(P<0.05).Compared between the groups,the observation group was better than the control group in improving the scores of TCM symptoms such as bloating,constipation,fatigue,afraid of cold and cold limbs(P<0.05),but there was no statistical difference between the two groups in other scores(P>0.05);3.Comparison of tumor markers: The average values of CEA and CA199 in the two groups were significantly lower after treatment(P<0.05).And compared between the groups after treatment,there were also significant differences in the average values and degrees of decrease of the two tumor markers(P<0.05);4.Comparison of KPS scores: The KPS scores of patients in the observation group were significantly improved after treatment(P<0.05),while the scores in the control group were not significantly improved(P>0.05);Compared between groups,the observation group was better than the control group(P<0.05);5.Comparison of the fecal occult blood test results: After treatment,the fecal occult blood test results were significantly improved in both groups(P<0.05),but there was no significant difference between the groups(P>0.05);6.Safety evaluation: There was a significant difference in leukopenia between the two groups after treatment(P<0.05),but the other adverse reactions were not statistically different.Conclusion:There is no significant difference between the two treatment schemes in the recent objective efficacy of tumors and improvement of the fecal occult blood test results,but the addition of traditional Chinese medicine can significantly improve some TCM symptoms scores of the patients,reduce tumor marker levels,and improve the patients’ quality of life.It can also improve patients’ tolerance to chemotherapy,and is safe and reliable. |
