| Background:At present,the incidence and mortality of malignant tumors continue to rise.According to the 2018 Global Cancer Statistics Report,the number and incidence of malignant tumors in China and the world are still rising.But with the continuous improvement of medical technology and level,the number of patients who can achieve tumor-bearing survival and long-term survival is also increasing.Therefore,for this part of patients,in addition to focusing on the treatment of the tumor itself,it is also necessary to pay attention to the clinical symptoms closely related to the quality of life.Cancer-related fatigue is one of the most common clinical symptoms in patients with malignant tumors.Like adverse reactions such as nausea and vomiting,it is also related to the quality of life of patients.The incidence of CRF is very high.It has been reported that the incidence of CRF in chemotherapy patients can be as high as 90%or more,but its clinical attention is very low,and currently Western medicine has limited treatment and poor efficacy.However,Traditional Chinese medicine(TCM)has a unique theoretical system and a wealth of treatments,and there are many effective reports of traditional Chinese medicine to treat cancer-related weakness.However,most of the current research does not regard CRF as the main observation index,most of the current studies do not regard CRF as the main observation index,most of them are only as secondary or even additional indicators,and the evaluation indicators are not uniform.Objective:To evaluate the efficacy of Shenqi Fuzheng Injection(SFI),a commonly used Chinese patent medicine for the treatment of advanced non-small cell lung cancer(NSCLC)related faitgue,to observe its effects on clinical symptoms of lung cancer,especially on the manifestations of qi-deficiency in TCM and on the KPS score.Methods:A prospective,multicenter cohort study was conducted to include patients with stage ???V NSCLC with qi-deficiency syndrome.Take SFI as the intervention factor,the research was divided into treatment group and control group,and control group was used the standard chemotherapy regimen for NSCLC recommended by the NCCN guidelines and the routine symptomatic treatment of vomiting and antiallergic.On this basis,the treatment group was treated with SFI for 250ml/day.Two chemotherapy cycles were observed,and each chemotherapy cycle was treated with intervention drugs ?7 days.The fatigue was evaluated before treatment,after the first cycle,and after the second cycle,by Piper fatigue revision scale,and the TCM clinical symptom score and KPS score were observed.Results:From April 2016 to January 2019,a total of 122 cases of stage ???V NSCLC with qi-deficiency syndrome were included in the three centers,including 62 cases in treatment group(Shenqi+chemotherapy group)and 60 cases incontrol group(Chemotherapy group).In the final treatment group,1 case was detached,1 case was excluded,and 1 case was detached from the control group.The results of the analysis found that there was no significant difference in age,gender,total fatigue score,the dimension of fatigue scale,TCM clinical symptom score of lung cancer,qi-deficiency syndrome score and KPS score between the two groups at baseline level.After treatment,the total score of fatigue scale was4.40 ±1.14,5.01±0.98 in the treatment group and the control group after the first course of treatment.The scores of the Shenqi+chemotherapy group were improved compared with the baseline score of 5.17 ±1.27 and the control group,and the difference was statistically significant.P values were 0.000 and 0.002 respectively;after the second course of treatment,the total score of fatigue in the Shenqi+chemotherapy group was7.12±2.93,and that in the control group was 9.38±2.16.The total score of fatigue in the two groups was higher after the second course of treatment.Baseline increased significantly and was statistically significant,but the comparison showed that the fatigue score of the Shenqi+chemotherapy group was still significantly lower than that of the control group,P value was 0.000.In the behavioral dimension,emotional dimension,physical dimension and cognitive dimension,the results showed that except for the behavioral dimension,after each treatment cycle,the fatigue scores of the treatment group were significantly lower than the control group in the other three dimensions,and the difference was statistically significant.After the treatment,the symptoms of TCM in the two groups were significantly improved after the second course of treatment.Compared with the control group,the scores of TCM symptoms were significantly improved,and the number of effective cases in the treatment group was statistically different.On the symptoms of fatigue,the scores of Shenqi+chemotherapy group were significantly improved compared with baseline and control group after each cycle of treatment,the difference was statistically significant.On the KPS score,it was found that although the KPS score of the patients in this group increased gradually with the prolongation of the intervention time after the intervention of SFI,the score of the control group decreased gradually.However,there was no significant improvement in the scores of the last two tests in the group and among the groups.Conclusion:SFI can alleviate and improve the fatigue symptoms and overall fatigue of patients with chemotherapy-related fatigue in NSCLC,especially in the emotional dimension,physical dimension and cognitive dimension.But as the chemotherapy cycle increases,it does not fundamentally reverse the patient's fatigue symptoms.SFI is effective in improving the TCM clinical symptoms of patients with chemotherapy in NSCLC,helps to improve the overall symptom score and improves the symptoms of fatigue.SFI can stabilize the KPS score of patients with non-small cell lung cancer during chemotherapy,but it does not show significant advantages. |
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