| Objective: This study is to observe the clinical efficacy and safety of Zini Kang Ai Fang Decoction in the treatment of cancer-related fatigue in patients with colorectal cancer of Spleen and Stomach weakness Type,and then to evaluate the effect of Zini Kang Ai Fang Decoction on quality of life of cancer-related fatigue in patients with colorectal cancer of Spleen and Stomach weakness Type,so as to provide scientific basis for TCM treatment of cancer-related fatigue.Methods: A total of 52 patients with cancer-related fatigue in patients with colorectal cancer of Spleen and Stomach weakness Type were selected from the inpatients or outpatients of Xianhu District of the first affiliated hospital of the Guangxi University of Chinese Medicine from January 2022 to January2023.The experimental group and the control group were randomly divided into 26 cases by SPSS Random Table method.The experimental group was treated with Zini Kang Ai Fang Decoction combined with usual treatments,while the control group was treated with usual treatments.And the safety indexes(WBC,HGB,PLT,AST,Alt,CR),TCM syndrome score,Piper score,KPS score,EORTC QLQ-C30 score were observed and recorded before and after two treatment cycles in both groups.Adverse events were evaluated and recorded during the entire observation period.Data were analysed with SPSS version 26.0.Results: 1.Baseline data: there was no significant difference in sex,age,tumor type and tumor stage between the two groups(P>0.05).2.KPS score: there was no significant difference in KPS score between the two groups before treatment(P>0.05),but there was significant difference in KPS score between the two groups after treatment.The KPS score of the Observation Group after treatment was significantly higher than that of the control group,the difference was significant(P<0.05).3.Piper score: there was no significant difference in the total score,behavioral dimension,emotional dimension,physical dimension and cognitive dimension between the two groups before treatment(P>0.05);There was no significant difference in the total score and the four dimensions of fatigue between the two groups after treatment(P>0.05).The Piper score of the Observation Group after treatment was lower than that before treatment(P< 0.05).4.TCM syndrome score: there was no significant difference between the two groups in the total score of syndrome,mental fatigue,shortness of breath,fatigue,self-sweating,lazy speech,pale or pale complexion,dizziness,palpitation,insomnia,numbness of hands and feet,tongue and pulse condition before treatment(P>0.05),the total score of syndrome and all symptoms were decreased after treatment,and the difference was statistically significant(P<0.05).The decrease of TCM syndrome score in the observation group was significantly greater than that in the control group,and the difference was statistically significant(P<0.05).5.EORTC QLQ-C30 score: there was no statistical significance in functional domain,symptom domain,single domain and general health status before treatment between the two groups(P>0.05).After treatment,the functional domain,symptom domain,single domain and general health status in the observation group decreased significantly(P<0.05).In the control group,the functional domains of body,pain,cognition and emotion decreased after treatment(P<0.05),while the functional domains of role and social function did not change significantly,there was no significant difference between the two groups(P >0.05),but the symptom domain of the control group decreased after treatment(P<0.05).In the control group,shortness of breath,anorexia and diarrhea decreased significantly after treatment(P<0.05).There was no significant difference in the fields of insomnia,constipation and economic difficulties before and after treatment in the control group(P>0.05),but the general health status of the control group decreased after treatment,the difference was significant(P<0.05).6.There was no significant difference in safety index between the two groups before treatment(P>0.05),but there was no significant difference in WBC,HGB,Alt and AST between the two groups after treatment(P>0.05),and there was significant difference in PLT between the two groups after treatment(P<0.05),there was significant difference in CR index in the control group after treatment(P<0.05).Conclusions: 1.Zini Kang Ai Fang Decoction combined with routine western medicine can effectively improve the clinical symptoms,TCM syndrome score and quality of life of patients with cancer-related fatigue related to colorectal cancer,and the clinical effect is better than that of simple Western medicine treatment.2.Zini Kang Ai Fang Decoction combined with routine western medicine has remarkable clinical effect and reliable safety in treating colorectal cancer-related cancer-related fatigue. |