Purpose of the Investigation:The clinical efficacy of Yiqi Detoxification Tongluo Formula was observed in the2nd-line curative management of late-stage ESCC with Qi deficiency and toxicity stagnation,compared with camrelizumab combined with apatinib and S-1 in the Western medicine treatment regimen alone,and evaluated the effects of Yiqi detoxification Tongluo Formula in the combination regimen on patients’ clinical Chinese medicine symptoms,ease of livelihood,oncology metrics,role of exemptions and poisonous of impact.In order to provide a new reference basis for the combined treatment of advanced esophageal squamous carcinoma with Chinese and Western medicine.Methods of the Investigation:In this study,60 patients with advanced esophageal squamous carcinoma with Qi deficiency and toxicity stagnation who met the incorporation standards and were referred to the Oncological Center of the First Affiliated Hospital of An Medical University from 2021.03 to 2022.06 were selected as study subjects,and the arbitrarily divided into Western medical treatment oriented cohort and combined Western and Chinese medical treatment cohort,with 30 patients in each cohort.The western medical treatment cohort was treated with camrelizumab,apatinib and S-1,while the other cohort was treated in association with Yi Qi detoxification and Tongluo formula.The primary observation indexes were DCR,ORR,change of TCM symptom score,KPS score,oncology metrics,role of exemptions and poisonous of impact in both cohort after 3 cycles of treatment(21 days as a cycle);the subsidiary observation indexes were PFS and OS of patients in both groups.Results:1.In this study,in the two cohorts,in terms of evidence of median age,gender etc differentiation,there were no statistically considerable differences in baseline data(P > 0.05).According to the results of the study,the ORR of the combined Chinese and Western medicine treatment cohorts and the Western medicine treatment cohorts were23.3% and 20.0%,respectively,and the DCR was 80.0% and 73.3%,respectively,with no statistically significant difference between the two cohorts(P>0.05);in terms of the TCM symptom score,the total TCM symptom score of both cohorts dropped dramatically compared with that before treatment,and the differences among cohorts were found to be either significant(P<0.01);The validity rate of 83.4% in the alliance cohort was superior to that of 53.3% in the Western medicine cohort,with a statistically significant variation between the cohorts(P=0.044).In regards to the KPS index,86.7%of the combined cohort had a more effective rate than 66.7% of the Western cohort,with a statistically significant variation in the two cohorts(P=0.028);the tumor indexes CEA,CA125 and SCC in both cohorts were slightly lower than those before therapy,but the difference between the two cohorts was no statistically significant(P>0.05).After therapy,CD8+ and CD4+/CD8+ in both cohorts increased slightly compared with those before therapy,but the difference between cohorts was not statistically significant(P>0.05),CD3+ and CD4+ rose compared with those before therapy,there was a noticeable augmentation in the combined cohort compared to the Western cohort,with a statistically significant difference between the cohorts(P=0.014,P=0.026).By the time the period of follow-up ended,the joint cohort had a Median PFS of 5.4 months(95%CI 4.3-6.5)and a Median OS of 7.6 months(95% CI 6.3-8.9);the Western cohort had a Median PFS of 4.6 months(95% CI 4.2-5.0)and a Median OS of 6.3 months(95% CI5.6-6.9.CI 5.6-6.9),the two cohorts had no substantially significante difference in PFS(P>0.05)and a substantially significante difference in OS between the two groups(P=0.047).2.In the aspect of unfavorable reactions,the incidence of the combined cohort was inferior to that of the Western cohort during therapy,including diarrhea and nausea and lethargy,with a statistically significant difference among the cohorts(P < 0.05),and the discrepancy among the two cohorts for the remaining statutory adverse events was not tatistically significant(P > 0.05).Conclusion:1.The second-line treatment of advanced esophageal squamous carcinoma with Qi deficiency and toxicity stagnation with Yiqi detoxification Tongluo Formula combined with camrelizumab,apatinib and S-1 can can improve patients’ TCM syndromes,which can raise the quality of life and the organism’s vaccination and prolong the survival of patients.2.Yiqi detoxification Tongluo Formula can reduce the incidence of nausea,vomiting,diarrhea and fatigue caused by camrelizumab,apatinib and S-1,and at the same time reduce the level of some adverse reactions,which has an exploitable application value in the treatment of advanced esophageal squamous cell carcinoma. |