| Objective:Observe the effect of Qingjie Fuzheng Granules on Cancer Related Fatigue of syndrome of deficiency of spleen qi and stomach qi of advanced colorectal cancer,evaluating its clinical efficacy and safety,and provide ideas for clinical diagnosis and treatment.Method:From the oncology department of our hospital,68 patients with CRF who conformed to the syndrome of deficiency of spleen qi and stomach qi of colorectal cancer in advanced stages were selected,and randomly divided into experimental group and control group according to the ratio of 1:1,34 cases in each group.The control group was only given routine symptomatic supportive treatment(including nutritional support,analgesia,laxative,hemostasis,etc.),and the experimental group added the Qingjie Fuzheng Granules on the basis of the control group.The observation period was 3 weeks.By observing and comparing the patient’s TCM syndrome integral,Piper fatigue scale,KPS score,PSQI scales and immune function index,etc,the efficacy of Qingjie Fuzheng Granules on Cancer Related Fatigue of the syndrome of deficiency of spleen qi and stomach qi of advanced colorectal cancer was evaluated,and its safety was assessed by blood routine examination,liver renal function,and electrocardiogram.Results:1.Compared the sex,age,BMI,tumor stage,tumor site and the Piper fatigue scale score,KPS score,PSQI score,TCM syndrome score and immune function index before treatment between two groups,the difference has not statistically significant(P>0.05).2.TCM syndrome score:TCM syndrome score before and after treatment was significantly decreased in both groups(P<0.05).Compared with the control group,TCM syndrome score in experimental group was significantly decreased after treatment(P<0.05).The effective rate was 84.4%in experimental group and 25.8%in control group,which was significantly higher than that in control group(P<0.05).3.Piper fatigue scale score:By compared internally,Piper total scores decreased significantly in both groups after treatment(P<0.05).Compared with the control group,Piper scores in experimental group decreased significantly after treatment(P<0.05).Through compare two groups of different dimensions fatigue scores inside the group,experimental group in all dimensions were significantly decreased(P<0.05),the control group only in the sense of fatigue and cognitive fatigue has decreased(P<0.05),no change in the behavior of fatigue and emotional fatigue(P>0.05),the dimension scores than the control group and experimental group were significantly decreased(P<0.05).From the evaluation of the efficacy of fatigue improvement,the effective rate of the experimental group was 59%,and that of the control group was 9.7%,the efficacy of the experimental group was significantly higher than that of the control group(P<0.05).Campared with the fatigue degree before treatment,the experimental group was significantly alleviated after treatment(P<0.05),while there was no significant change in the control group(P>0.05).4.KPS score:By internal comparison,there was no significant difference in KPS score in the two groups after treatment(P>0.05).The efficacy evaluation of the two groups was compared,and the difference was not statistically significant(P>0.05).5.PSQI scale score:There was no significant difference in PSQI score before and after treatment in the control group(P>0.05),and there was significant difference in PSQI score before and after treatment in the experimental group(P<0.05).Compared the efficacy evaluation between the two groups,There was no significant difference(P>0.05).6.Immune function index:Compared with the Immune function index before treatment,CD3~+,CD4~+,CD4~+/CD8~+increased and CD8~+decreased in the experimental group(P<0.05),while CD3~+,CD4~+,CD4~+/CD8~+decreased and CD8~+increased in the control group(P<0.05).Conclusion:The Qingjie Fuzheng Granules can effectively relieve fatigue symptoms,enhance immunity,and improve sleep quality in CRF patients of syndrome of deficiency of spleen qi and stomach qi of advanced colorectal cancer,with good safety and no obvious adverse reactions. |