| ObjectiveThe purpose of this study was to observe the effect and safety of the Shugan Jianpi method on the quality of life(Quality of Life,QOL)of postoperative chemotherapy patients with breast cancer.Combined with the professional theoretical knowledge of traditional Chinese medicine and clinical practice,to explore the advantages and characteristics of traditional Chinese medicine in the treatment of breast cancer based on syndrome differentiation,to provide effective methods for improving the QOL of postoperative chemotherapy patients with breast cancer,and to provide more ideas and references for comprehensive treatment of malignant tumors and improving patients’ QOL.Methods:Collecting postoperative chemotherapy patients with breast cancer who were hospitalized in the second affiliated Hospital of Tianjin University of traditional Chinese Medicine from January 2019 to December 2020.According to the inclusion and exclusion criteria,66 subjects were selected and randomly divided into observation group(n = 33)and control group(n = 33).The observation group was given routine symptomatic treatment of western medicine plus oral Shugan Jianpi decoction,while the control group was given routine symptomatic treatment of western medicine alone.After continuous treatment for 28 days,the scores and indexes of patients before and after treatment were observed and recorded.The quality of life score(EORTCQLQ-BR53),TCM syndrome score and functional status(KPS)score of breast cancer patients were mainly observed to evaluate the effect of Shugan Jianpi recipe on the quality of life of postoperative chemotherapy patients with breast cancer.Blood routine and liver and kidney function were used as safety indicators to monitor the safety of the two groups.The observed data were statistically processed by SPSS26.0 software,and the changes of quality of life and adverse reactions of the two groups were compared and analyzed,and a conclusion was drawn.Results:In the course of clinical study,a total of 6 patients fell off,including 3 cases in the control group and 3 cases in the observation group.Finally,60 patients actually completed the clinical study,including 30 cases in the control group and 30 cases in the observation group.1.Baseline situationThe data of age,marital status,operation mode,chemotherapy cycle,QOL score(EORTC QLQ-BR53),KPS score and TCM syndrome score of the two groups before treatment were statistically analyzed.The results showed that P > 0.05,there was no statistical difference,indicating that there was comparability between the two groups.2.The quality of life score(EORTC QLQ-BR53)Observation group: after treatment,the scores of overall health status,functional collar and symptom field in the observation group were compared with those before treatment(P <0.05),and there was statistical difference.Control group: After treatment,the scores of general health status,functional field,fatigue,nausea and vomiting,pain,shortness of breath,insomnia,side effects of systematic therapy,breast symptoms,arm symptoms and hair loss in the control group were significantly lower than those before treatment(P < 0.05).There was no statistical significance in the scores of anorexia,constipation and diarrhea(P > 0.05).Between the two groups: After treatment,the scores of overall health status,physical function,emotional function and fatigue,nausea and vomiting,insomnia,loss of appetite,diarrhea and arm symptoms were compared between the two groups(P < 0.05).There was statistical difference.There was no significant difference in the scores of role function,cognitive function,social function,somatotype,future view,pain,shortness of breath,constipation,side effects of systematic therapy,breast symptoms and alopecia(P > 0.05).3.Functional status(KPS)scoreObservation group: there was significant difference in KPS score before and after treatment(P < 0.05).Control group: there was no significant difference in KPS score before and after treatment(P > 0.05).Between the two groups: there was significant difference in KPS score between the two groups after treatment(P < 0.05).4.TCM symptom scoreObservation group: the TCM syndrome scores of patients after treatment were significantly higher than those before treatment(P < 0.05).Control group: the TCM syndrome scores of patients after treatment were significantly higher than those before treatment(P < 0.05).Between the two groups: there was significant difference in TCM syndrome scores between the two groups after treatment(P < 0.05).Curative effect: there was significant difference in the curative effect of TCM syndrome between the two groups after treatment(P < 0.05).5.Safety monitoringComparing the blood routine(WBC,HGB,PLT),liver function(ALT,AST),renal function(UREA,Cr)of the two groups before and after treatment,the results showed that P>0.05,no statistical difference.Conclusions:1.The Shugan Jianpi method can effectively improve the quality of life of postoperative chemotherapy patients with breast cancer.2.The Shugan Jianpi method can effectively improve the overall health status,physical function and emotional function of postoperative chemotherapy patients with breast cancer,and reduce clinical symptoms such as fatigue,nausea and vomiting,insomnia,loss of appetite,diarrhea,arm symptoms and so on.3.The Shugan Jianpi method can effectively reduce the TCM symptoms of postoperative chemotherapy patients with breast cancer.4.The Shugan Jianpi Method has no obvious adverse reactions and is safe. |