| Objective: To evaluate the clinical feasibility and safety of Buqi Huoxue decoction(Buqi Huoxue decoction)combined with immunotherapy and chemotherapy in the treatment of esophageal cancer with qi deficiency and blood stasis.Methods: A total of 60 patients who met the criteria were enrolled in this randomized controlled trial.According to the random number table method,60 patients were divided into a control group and an observation group,30 cases in each group.The control group was given conventional treatment,which included: all patients were given camrelizumab 200 mg iv d1 for injection,repeated every 4 weeks,as a course of treatment;S-1 capsules 25 mg po d1-D21 bid(0.5h after breakfast and dinner),discontinued for 1 week,as a course of treatment.Observation group: on the basis of the control group,Buqi Huoxue decoction was orally decocted with water,1 dose per day,about 300 ml,taken twice,1 hour after breakfast and dinner.The two groups received two courses of treatment for a total of 8 weeks.The size of primary tumor,TCM syndrome score,Piper fatigue scale,KPS score,immune function index and safety index of the two groups were accurately recorded before treatment and at the end of treatment.Results: All the 60 cases included in this study completed all clinical tests as scheduled,and no cases dropped out.There was no significant difference in general baseline data between the two groups(P>0.05).The results showed that:(1)In terms of short-term efficacy evaluation: there was no significant difference in short-term efficacy between the observation group and the control group(P>0.05).Although the ORR of the two groups was the same,the DCR of the observation group(73.3%)was higher than that of the control group(66.7%).(2)TCM syndrome scores and efficacy evaluation: the TCM syndrome scores of the two groups were significantly improved after treatment(P<0.05).The improvement of the observation group was more significant than that of the control group,the difference was statistically significant(P<0.05).(3)Piper scale score and curative effect evaluation: after treatment,the scores of behavior,emotion,feeling and cognition in the observation group were significantly improved(P<0.05),and there was no significant change in the control group(P>0.05).After treatment,the scores in the observation group improved better than those in the control group(P<0.05).In terms of efficacy evaluation,the difference between the two groups was statistically significant(P<0.05).(4)The KPS scores of the two groups after treatment were improved compared with those before treatment,and the total effective rate of the two groups(observation group 76.7% vs control group 50%)was statistically significant(P<0.05).(5)Immunological indicators: CD4+ and CD4+/CD8+ values in the observation group after treatment increased,CD8+ values decreased,the comparison before and after treatment was statistically significant;In the control group,the change range was small(P<0.05).After treatment,there were statistically significant differences in immune function indexes between the two groups(P<0.05).(6)There was no severe bone marrow suppression and liver and kidney function damage in the two groups before and after treatment,and the blood indexes were within the normal range of medication,and the difference was not statistically significant.Conclusion: Compared with immunotherapy and chemotherapy alone in the treatment of esophageal cancer of qi deficiency and blood stasis type,Buqi Huoxue decoction combined with chemotherapy can improve the TCM syndrome score,Piper scale score,KPS score and immunological indexes of the patients,and the traditional Chinese medicine decoction is safe and has no obvious adverse reactions,which has good clinical application value. |
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