| Objective:Cancer-related fatigue(CRF)is one of the common concomitant symptoms in cancer patients.It occurs fast and lasts for a long time,seriously damaging the physical function of tumor patients and increasing their psychological burden.Further more,CRF severely reduces the quality of life of cancer patients.At present,the clinical intervention methods for CRF in clinic are limited and the effect is not significant enough.In this study,We aim to provide new treatment methods of cancer-related fatigue,ultimately in order to achieve the goal of improving the clinical symptoms and quality of life of cancer patients,by observing the clinical efficacy and safety of modified Shengyang Yiwei Decoction combined with Sanxian Decoction on patients with Qi-deficiency cancer-related fatigue.Method:A total of 60 patients with cancer-related fatigue of Qi deficiency type were selected from the oncology ward of Wuqing Traditional Chinese Medicine(TCM)Hospital Affiliated to Tianjin University of Traditional Chinese Medicine from May 2020 to January 2021.The patients were randomly divided into observation group and control group,with 30 cases in each group according to the time sequence of their visit.The control group were given the conventional therapy.On the basis of the routine trearment,the observation group were given oral Shengyang Yiwei Decoction combined with Sanxian Decoction.Therapeutic evaluation indicators mainly included the scores of TCM syndrome of Qi Deficiency,the Revised Piper Fatigue Scale-Chinese Version(RPFS-CV),Karnofsky Performance Status(KPS),European Organization for Research and Treatment Quality of Life Questionnaires-Cancer 30(EORTC QLQ-C30).Heart Rate(HR),White Blood Cell(WBC),Alanine Aminotransferase(ALT)and Creatinine(Cr)were regarded as safety indicators.Before and 2 weeks after the treatment,all the indicators and adverse reactions were recorded and evaluated.In this study,the results were statistically analyzed by SPSS 26.0.Results:1.A total of 60 patients with Qi-deficiency cancer-related fatigue were collected from the oncology ward of Wuqing TCM Hospital from May 2020 to January 2021.Among them,with two drop-out cases in the control group,one patient fell off in the observation group.Eventually,57 patients were included in the analysis.2.Baseline data: There were no statistically significant differences in terms of ge nder,age,tumor type and stage,and tumor diagnosis time between the two groups(P>0.05).3.Observation indicators:3.1 In terms of TCM syndrome scores of Qi Deficiency,the total scores of syndromes,scores of shortness of breath,mental fatigue,hypodynamia,spontaneous sweating and laziness to speak after treatment were lower than those before treatment between the two groups(P<0.05).Compared with the control group,the total scores of syndromes,scores of shortness of breath,mental fatigue,hypodynamia,spontaneous sweating and laziness to speak decreased more significantly in the observation group(P<0.05).The curative effect of the observation group was better than that of the control group(P<0.05).The overall effective rate in the observation group was 75.86 %,and that in the control group was 31.14 %,and the difference was statistically significant(P<0.05).3.2 KPS scores of the two groups after treatment were higher than before treatment(P<0.05).KPS scores of the observation group increased more significantly than that of the control group(P<0.05).3.3 In terms of Piper Fatigue score,the total average score of fatigue,behavioral dimension,emotional dimension,sensory dimension and cognitive dimension scores of the two groups after treatment were lower than those before treatment(P<0.05).The decrease of the observation group was more obvious than that of the control group(P<0.05).3.4 In terms of QLQ-C30: in terms of function,the scores of body,role,cognition,emotion and social function in the observation group were higher than those before treatment(P<0.05),and the scores of body and role function in the control group were higher than those before treatment(P<0.05).There was no significant difference in cognition,emotion and social function before and after treatment in the control group(P>0.05).The scores of physical,cognitive,emotional and social function in the observation group were significantly higher than those in the control group(P<0.05).The difference between the two groups about the scores of role function was not statistically significant(P>0.05).In the field of main symptoms,the scores of fatigue,nausea and vomiting and pain in the observation group after treatment were lower than those before treatment(P<0.05).The scores of fatigue and pain in the control group after treatment were lower than those before treatment(P<0.05).There was no significant difference in the scores of nausea and vomiting before and after treatment(P>0.05).Compared with the control group,the scores in the observation group decreased more significantly in terms of fatigue(P<0.05).The decrease of two groups in nausea and vomiting and pain was not significant(P>0.05).In the field of single symptoms,the scores of shortness of breath,insomnia,loss of appetite and diarrhea in the observation group after treatment were lower than those before treatment(P<0.05).There was no significant change in constipation and economic difficulties before and after treatment in the observation group(P>0.05).The scores of shortness of breath in the control group after treatment were lower than those before treatment(P<0.05).In the control group,the scores of insomnia,loss of appetite,constipation,diarrhea and economic difficulties had no significant decrease(P>0.05).Compared with the control group,in the observation group the scores of shortness of breath,anorexia and diarrhea decreased more significantly(P<0.05),while the scores of insomnia,constipation and economic difficulties were not significantly lower(P>0.05).In the field of overall quality of life,The scores of the two groups increased,and the observation group increased more significantly than the control group(P<0.05).4.Safety: There was no abnormality in the safety indexes of the two groups before and after treatment.And no adverse events occurred in either group.Conclusion:1.Modified Shengyang Yiwei Decoction combined with Sanxian Decoction and ro utine trearment can relieve the symptoms of Qi Deficiency,enhance the physical stren gth of CRF patients,multi-dimensionally improve the clinical symptoms and the qualit y of life.2.Modified Shengyang Yiwei Decoction combined with Sanxian Decoction and routine trearment in the treatment of CRF with Qi Deficiency has reliable clinical efficacy and safety.It is worthy of clinical promotion without side effects. |