| Objective:This study observed the clinical efficacy and safety of Jianpi Jiedu Quyu prescription combined with mFOLFOX6+ bevacizumab in the treatment of patients with advanced spleen deficiency and toxic stasis colorectal cancer,and provided clinical ideas for the treatment of advanced colorectal cancer with integrated traditional Chinese and western medicine.Methods:Sixty-four patients with advanced spleen deficiency and toxic stasis colorectal cancer were randomly divided into two groups,with 32 patients in each group.The treatment plan of the control group is mFOLFOX6 +bevacizumab,and the treatment plan of the treatment group is based on the control group combined with Jianpi Jiedu Quyu prescription.The 14-day period was 1 cycle,and the two groups were treated for 3 consecutive cycles.Record and compare the TCM syndrome scores,curative effect of solid tumor,KPS score,CEA,CA19-9 levels and adverse reactions before and after treatment in the two groups.The collected data were analyzed with statistical software SPSS 26.0,and it was considered that P<0.05 was statistically significant.Results:1.Baseline comparison: There was no statistically significant difference between the treatment group and the control group in terms of age,sex,primary and metastatic sites and various observation indicators before treatment(P>0.05),which could be compared.2.Comparison of TCM syndromes: After treatment,there were statistical differences in scores between the two groups and within each group(P<0.05).The effective rate of TCM syndrome in the treatment group and the control group were 80.00% and 54.84%,respectively,and the difference was statistically significant(P<0.05).There were statistical differences between the treatment group and the control group in improving drowsiness and fatigue,eating less and not eating too much,abdominal pain refusing to press,nausea and vomiting,loose stools,posterior weight and blood in stool(P<0.05),indicating that the treatment group had a more significant effect in improving TCM syndromes.3.Comparison of curative effect of solid tumor: ORR and DCR of the treatment group were 26.67% and 76.67% respectively,while ORR and DCR of the control group were 22.58% and 70.97% respectively.The data of the two groups showed that the effective rate of the treatment group was higher than that of the control group,but there was no statistical difference(P>0.05),indicating that the two groups had the same effect in the control of solid tumors.4.Comparison of KPS scores: After treatment,the scores of the two groups were compared,and the difference was statistically significant(P<0.05).Within the treatment group,the difference was statistically significant(P<0.05),while the control group had no statistically significant difference(P>0.05).The effective rates of the treatment group and the control group were 86.67% and 74.19%,respectively,with statistical significance(P<0.05),indicating that the treatment group had a more significant effect in improving the functional status of patients.5.Comparison of tumor markers: There were statistically significant differences in CEA before and after treatment between the two groups(P<0.05),but no statistically significant differences in CA19-9(P>0.05).After treatment,CEA was compared between the two groups,the difference was statistically significant(P<0.05),but CA19-9 was not statistically significant(P>0.05),indicating that the treatment group was better than the control group in reducing CEA level,and the two groups had similar effects in reducing CA19-9 level.6.Safety comparison: No grade III or IV adverse reactions occurred in two groups,and the occurrence of adverse reactions in the treatment group was lower than that in the control group,with statistically significant differences in myelosuppression,nausea,vomiting and diarrhea(P<0.05),while no statistically significant differences in other adverse reactions(P>0.05).It showed that the treatment group had more advantages and better safety in reducing the occurrence of adverse reactions in patients.Conclusions:Jianpi Jiedu Quyu prescription combined with western medicine in the treatment of patients with advanced spleen deficiency and toxic stasis colorectal cancer can significantly improve the patient’s discomfort,promote the recovery of patients’ functional status,effectively improve the quality of life of patients,significantly reduce the level of CEA,and significantly reduce the incidence of side effects after treatment,which is worthy of clinical promotion. |