Clinical Study Of Fuzheng Jiedu Decoction In The Treatment Of Cancer-related Fatigue In The Patients With Spleen Deficiency Syndrome And Gastrointestinal Tumor Undergoing Chemotherapy

ObjectiveTo evaluate the efficacy and safety of Fuzheng Jiedu Decoction in the treatment of cancer-related fatigue in the patients with spleen deficiency syndrome and gastrointestinal tumor undergoing chemotherapy.MethodsThis study is a prospective,randomized and controlled trial.From July 2020 to January 2021,52 patients who met the inclusion criteria in outpatients and wards of Guangdong Hospital of Traditional Chinese Medicine were collected.In this study,52 patients were divided into treatment group and control group by random number table method,with 26 patients in each group.The treatment group was given Fuzheng Jiedu Decoction orally on the basis of chemotherapy and symptomatic treatment,while the control group was given Jiedu Decoction orally on the basis of chemotherapy and symptomatic treatment.The course of treatment was 8 weeks.The primary efficacy indicator was the Revised Piper’s Fatigue Scale-Chinese Version(RPFS-CV),and the secondary efficacy indicators were European Organization for Research and Treatment Quality of Life Questionnaires(EORTC QLQC30),KPS score,TCM syndrome score table of spleen deficiency,peripheral blood test(red blood cell(RBC),white blood cell(WBC),hemoglobin(HGB),platelet(PLT),albumin(ALB),T lymphocyte subsets).Baseline comparison of basic information was conducted before treatment in both groups,and then,primary efficacy indicator,secondary efficacy indicators and medication safety were evaluated at the eighth week of treatment.The data in the study will be statistically analyzed by SPSS 18.0 software.Results52 patients,including 26 in the treatment group and 26 in the control group,were enrolled in this study.No case shedding or loss of follow-up occurred during the study.All the 52 patients were analyzed for the primary efficacy indicator,while in the analysis of the secondary efficacy indicators,some patients refused to detect the level of T lymphocyte subsets in peripheral blood,so 45 patients participated in the analysis of this indicator,and 52 patients were included for the analysis of the remaining secondary efficacy indicators.In terms of the main efficacy indicators(Piper fatigue score),the scores of behavioral dimension,affective dimension,perceptual dimension,cognitive dimension and total score of this group of patients in the treatment group were decreased after 8 weeks of treatment compared with those before treatment,with statistical significance(P<0.05).After 8 weeks of treatment,the behavioral,emotional and perceptual dimensions and total scores of the treatment group were lower than those of the control group,and the difference between the two groups was statistically significant(P<0.05).The secondary efficacy indicators:①EORTC QLQ-C30 score:Functional areas:After 8 weeks of treatment,the scores of body,role and emotional function of patients in the treatment group were higher than those before treatment,with statistical significance(P<0.05).After 8 weeks of treatment,the scores of physical and emotional function in the treatment group were higher than those in the control group,and the difference was statistically significant(P<0.05).Total health status and symptom areas:After 8 weeks of treatment,the scores of total health status,fatigue,nausea and vomiting,pain,insomnia,loss of appetite and diarrhea in the treatment group were decreased compared with those before treatment,with statistical significance(P<0.05).After 8 weeks of treatment,there were statistically significant differences in the scores of total health status,fatigue,pain,insomnia,loss of appetite and diarrhea between the treatment and control groups(P<0.05).②KPS score:After 8 weeks of treatment,the KPS score of patients in the treatment group was higher than that before treatment,and the difference was statistically significant(P<0.05).After 8 weeks of treatment,the KPS score of the treatment group was higher than that of the control group,and the difference was statistically significant(P<0.05).③TCM syndrome score table of spleen deficiency:After 8 weeks of treatment,the scores of temper weakness syndrome in the treatment group decreased compared with before treatment,and the difference was statistically significant(P<0.05).In the treatment group and the control group,after 8 weeks of treatment,there were statistically significant differences in the syndrome scores and efficacy evaluation of temper weakness between the two groups(P<0.05).④Peripheral blood test:After 8 weeks of treatment,the levels of CD3+and CD4+in peripheral blood of patients in the treatment group were higher than those before treatment,and the difference was statistically significant(P<0.05).After 8 weeks of treatment,the levels of ALB,CD4+and CD4+/CD8+in the treatment group were higher than those in the control group,and the difference between the two groups was statistically significant(P<0.05).Safety evaluation:There was no statistical significance in the occurrence of leukopenia,anemia and other adverse events and the use of major adjuvant drugs between the two groups(P>0.05).No grade 4 or 5 adverse events occurred in both groups,and grade 3 adverse events occurred in 2 patients,including 1 case of leukopenia and 1 case of anemia in the treatment group.In this study,the incidence rate of grade 2 adverse events is low,and the maj ority of adverse events were grade 1.The overall data show that Fuzheng Jiedu Decoction has good safety.Conclusion1.Fuzheng Jiedu Decoction can improve the behavior,emotion and perception functions of patients with cancer-related fatigue after chemotherapy for the gastrointestinal tumor with spleen deficiency syndrome,and can effectively improve the overall level of fatigue of patients.2.Fuzheng Jiedu Decoction can improve patients’ physical and emotional functions,relieve fatigue,nausea and vomiting,pain,insomnia,loss of appetite and diarrhea,and improve patients’ overall health status.3.Fuzheng Jiedu Decoction can reduce the TCM syndrome score and improve the quality of life of patients.4.Fuzheng Jiedu Decoction can improve the nutritional status and immune function of patients.5.Fuzheng Jiedu Decoction has good safety.