| Objective:To evaluate the efficacy and safety of invigorating spleen,regulating qi and detoxicating herbs(Fuzhong Kangwei Yin)combined with chemotherapy in the treatment of advanced gastric cancer after surgery,and to explore the efficacy and benefit of traditional Chinese medicine combined with chemotherapy in the treatment of advanced gastric cancer after surgery.Methods:This study used a prospective cohort study,and selected the clinical data of postoperative patients with advanced gastric cancer from 11 centers including Xiyuan Hospital of China Academy of Chinese Medical Sciences as the study subjects.Two hundred and seventeen postoperative patients with advanced distal gastric cancer with pathological stage consistent with T2 NxMO were included and divided into traditional Chinese medicine combined with chemotherapy group according to whether Fuzhong Kangwei Yin,a traditional Chinese medicine for invigorating spleen,regulating qi and detoxicating,was used or dialectical traditional Chinese medicine based on this method.Fuzhong Kangwei Decoction or TCM syndrome differentiation treatment was used on the basis of standard chemotherapy for a cumulative period of not less than 6 months,and only standard chemotherapy regimen+symptomatic and supportive treatment was used from the time of chemotherapy group entry to the observation endpoint.Postoperative progression-free survival(PFS),progression-free survival(PFS)and quality of life(QOL)scores were calculated by analyzing the data of gastroscopy+pathology,imaging,cancer professional scales EORTC QLQ-C30 and EORTC QLQ-ST022 collected at each visit after surgery.The PFS and progression-free survival rates of each group were analyzed and survival curves were plotted using the Kaplan-Meier method,and the survival curves of the two groups were compared using the log-rank method.The Wilcoxon rank sum test for independent samples was used to compare the scores between groups of the Gastric Cancer Quality of Life Scale.The statistical software uses SAS version 9.3.The difference test is used.P less than or equal to 0.05 is considered statistically significant.According to age(≥60 or<60),T stage(T2/T3-4),N stage(N0/N1-X),combined disease(yes/no)and other four related influencing factors,a cox multivariate and subcomponent stratification study was conducted to analyze the related factors affecting the survival prognosis in this study and explore the efficacy benefit population of traditional Chinese medicine combined with chemotherapy in the intervention of advanced gastric cancer after surgery.The quality of life of patients at each postoperative visit and the difference before and after treatment were compared and evaluated based on the EORTC QLQ-C30 and EORTC QLQ-ST022.Results:1.217 patients were actually included in this study,including 158 patients in the traditional Chinese medicine combined with chemotherapy group and 59 patients in the chemotherapy group.The male to female ratio was 119:39 and the mean age was 58.16±10.08 years in the TCM combined with chemotherapy group;the male to female ratio was 44:15 and the mean age was 58.60±11.41 years in the chemotherapy group,and there were no significant differences in age or gender(P>0.05).2.The comparison of postoperative progression-free survival(PFS)and progression-free survival rate showed that the postoperative PFS was 14.25±5.12 months and 13.34±6.43 months in the TCM combined with chemotherapy group,which was higher in the TCM combined with chemotherapy group than in the chemotherapy group,but the difference was not statistically significant(P>0.05),and there was no significant difference in the survival curve data between the two groups(P>0.05).3.The results of multivariate analysis showed that tumor stage N was an independent factor for progression-free survival(P<0.05),and other grouping factors had no significant effect on progression-free survival(P>0.05).There was significant difference in postoperative PFS between the two groups(P<0.05).The postoperative PFS in the traditional Chinese medicine combined with chemotherapy group was higher than that in the chemotherapy group.There was no significant difference in postoperative PFS between the other groups(P>0.05).4.Based on the scales EORTC QLQ-C30 and EORTC QLQ-ST022,the scores of each visit node in different fields and the difference from the baseline were evaluated.The results showed that in the physical function domain,the difference in the scores was significant only at 9 months after operation,the score of the TCM combined with chemotherapy group was lower than that of the chemotherapy group(P<0.05),and there was no significant difference at 24 months after operation,(P>0.05);the difference between 12 months,18 months,24 months after operation and 6 months after operation was significant,all of which were the scores of the TCM combined with chemotherapy group increased(P<0.05).In the field of cognitive function,the difference in the scores was significant at 6 and 24 months after surgery,and the scores of the TCM combined with chemotherapy group were lower than those of the chemotherapy group(P<0.05);the differences at each time point were significant,both of which showed that the scores of the TCM combined with chemotherapy group increased(P<0.05).In the field of emotional function,the difference in the score was significant at 6 months after operation,and the score of the traditional Chinese medicine combined with chemotherapy group was lower than that of the chemotherapy group(P<0.05);the difference between 12 months,24 months after operation and 6 months after operation was significant,all of which were the score improvement of the traditional Chinese medicine combined with chemotherapy group(P<0.05).In the comparison of fatigue,dysphagia,limited eating,taste changes,dry mouth,nausea and vomiting,constipation,pain,and other symptoms and overall health domains,there were significant differences in the scores at each time point and the difference before and after treatment,all of which were better in the traditional Chinese medicine combined with chemotherapy group than in the chemotherapy group(P<0.05).5.Safety analysis:A total of 217 patients completed this study,and no serious adverse events occurred in the two groups during the study.Conclusion:1.The method of invigorating the spleen,regulating qi and detoxicating Chinese herbal compound(Fuzhong Kangwei Yin)combined with chemotherapy has certain positive significance for the improvement of progression-free survival and quality of life after advanced gastric cancer surgery,with certain clinical efficacy and better safety.2.Pathological tumor stage N is an independent factor affecting the survival and prognosis of patients with advanced gastric cancer after surgery,and people with concomitant diseases may benefit from such intervention regimens of traditional Chinese medicine compound combined with chemotherapy. |
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