| Objective:To investigate the clinical pathological characteristics and analyze the influence of Jianpi Yiwei Decoction on recurrence and metastasis,disease-free survival,overall survival and side effects of chemotherapy in patients with gastric cancer after radical operation by retrospective cohort study,so as to explore the independent influencing factors of recurrence and metastasis and disease-free survival in patients with gastric cancer after radical operationMethods:From January 1,2013 to January 1,2020,patients in China-Japan Friendship Hospital with advanced gastric cancer who underwent radical surgery in the Department of oncology integrated traditional Chinese and Western medicine and the Department of general surgery were selected as the research objects.The basic research information of patients was collected by using hospital information system and medical record system,including gender,age,smoking history,drinking history,Helicobacter pylori infection history,preoperative CEA level,tumor location,degree of differentiation,longest diameter of tumor,depth of invasion,number of lymph node metastasis,number of lymph node dissection,lymph node ratio,postoperative TNM stage,nerve invasion,vascular tumor thrombus,tumor nodule,surgical margin,number of chemotherapy cycles,TCM syndrome,intervention of Jianpi Yiwei Decoction.According to whether there was Jianpi Yiwei Decoction intervention for more than 6 months,the patients were divided into traditional Chinese medicine combined treatment group and chemotherapy group.The recurrence and metastasis,disease progression time and death time were recorded by interview or telephone follow-up.The collected case information was sorted and entered into excel.SPSS 25.0 was used for data analysis.The baseline data of the two groups were adjusted by propensity score matching to control the bias.The differences of recurrence and metastasis rates between the two groups were compared by Chi square test.The Kaplan-Meier method was used to draw the survival curve.The 1-year,3-year and 5-year survival rates,median disease-free survival(mDFS)and median overall survival(mOS)of the two groups were estimated,the Log rank method was used for significance test.Analyze the relationship between TCM Syndrome types and postoperative recurrence and metastasis.Univariate and Cox multivariate regression models were used to analyze the independent predictors of disease-free survival.The incidence of side effects was compared between the two groups.The significance level of all statistical analysis was a=0.05.Results:1.The study included 196 patients,92 cases inthe combination of traditional Chinese medicine and 104 cases in the simple chemotherapy group.The total follow-up time was 8.1-98.1 months,the median follow-up time was 42.2 months.12 patients lost to follow up,140 cases happended tumor recurrence and metastasis,the recurrence rate was 71.4%,84 cases were tumor related deaths,and the mortality rate was 42.9%.There were significant differences in preoperative CEA level,number of chemotherapy cycles and tumor nodules between the two groups at beginning of the research.It is not conducive to comparison,so SPSS 25.0 software is used to match 1:1 tendency score with 0.01 calipers value.63 pairs of patients are matched successfully.After matching,the indicators of the two groups are balanced and comparable.2.After matching,there were 63 patients in each group.In the Jianpi Yiwei decoction group,42 cases had recurrence and metastasis,with a recurrence rate of 66.7%.,among them,10 cases(23.8%)had early recurrence and metastasis(recurrence within 2 years after operation)and 32 cases(76.2%)had late recurrence and metastasis(recurrence more than 2 years);There were 51 cases of recurrence and metastasis in chemotherapy group,the recurrence rate was 81.0%,27 cases of early recurrence and metastasis(52.9%)and 24 cases of late recurrence and metastasis(47.1%),the difference was statistically significant(x2=11.408,P=0.003).The incidences of local recurrence,hematogenous metastasis,implantation metastasis and lymph node metastasis were 42.9%vs 39.2%,69%vs 76.5%,26.2%vs 43.1%and 33.3%vs 43.1%in Jianpi Yiwei decoction group and chemotherapy group respectively.Hematogenous metastasis was the most common mode,the incidence of liver metastasis was highest.There was no significant difference in recurrence and metastasis mode between the two groups(P>0.05).3.After matching,the median disease-free survival(mDFS)was 33.9 months in the Jianpi Yiwei decoction group,24.4 months in the chemotherapy group(P<0.001).The 1-year,3-year and 5-year cumulative recurrence rates of the combined treatment group and the simple treatment g oup were 3.2%vs 11.2%,52.0%vs 84.9%,74.1%vs 90.7%,respectively.4.After matching,the median overall survival(mOS)was 61.6vs52.8 months in combined treatment group and chemotherapy group,P=0.014.The difference was statistically significant.The 1-year,3-year and 5-year survival rates of the combined treatment group and the simple treatment group were 100%vs100%,90.9%vs 76.4%,57.2 vs 35.8%,respectively5.The 92 patients in the combined treatment group were divided into 6 types,including 3 cases of liver Qi invading the stomach,22 cases of stomach heat injuring Yin,17 cases of spleen stomach deficiency cold,14 cases of qi stagnation and blood stasis,24 cases of phlegm dampness coagulation and 12 cases of Qi blood deficiency.Recurrence and metastasis were 2 cases(66.7%),11 cases(50%),13 cases(76.5%),9 cases(64.3%),14 cases(58.3%),12 cases(100%).Comparing the recurrence and metastasis rates of different syndrome types,the difference was statistically significant(?2=10.209,P=0.037).After excluding the syndrome of liver Qi invading stomach,the mDFS of the above syndrome types were 42.0 months,35.1 months,33.4 months,38.3 months and 26.0 months,respectively,with log rank test P=0.079>0.05,and the difference was not statistically significant.6.Cox multivariate analysis showed that Jianpi Yiwei decoction combined treatment(HR=0.365,P<0.001)was independent protective factors for disease-free survival after radical gastrectomy.high positive lymph node ratio(HR=6.057,P<0.001),pathological stage ?(HR=2.799,P<0.001),positive vascular tumor thrombus(HR=1.784,P=0.005),positive surgical margin(HR=2.332,P=0.005)were the risk factors for disease-free survival after radical gastrectomy independent risk factors.ROC curve showed that the cut-off value of LNR for predicting recurrence and metastasis was 0.16,the sensitivity and specificity were 70.3%and 77.6%respectively,which had good clinical significance.The patients were divided into<0.16 group and?0.16 group according to the cut-off value,and the median disease-free survival of the two groups was 38.5 months vs 24.0 months,P<0.0017.There were different degrees of adverse reactions in the two groups.The incidence of grade ?-? leucopenia(19.2%vs 7.6%),neutropenia(30.8%vs 8.7%),thrombocytopenia(18.3%vs 3.3%)and peripheral neurotoxicity(28.8%vs 5.4%)in the chemotherapy group was higher than that in Jianpi Yiwei decoction group(P=0.018,P<0.001,P=0.001,P=0.007).Conclusion:1.There was no significant difference in recurrence and metastasis pattern between Jianpi Yiwei Decoction group and chemotherapy alone group.2.Jianpi Yiwei decoction can reduce the recurrence and metastasis rate,prolong the disease-free survival and overall survival,and improve the 5-year survival rate.It is an independent protective factor for disease-free survival after radical gastrectomy.3.Jianpi Yiwei decoction can reduce the side effects of chemotherapy,improve the quality of life of patients,improve the completion rate of chemotherapy,and avoid the increased risk of recurrence and metastasis due to insufficient postoperative treatment.4.There is correlation between TCM syndrome and recurrence after radical operation.The recurrence and metastasis rate of patients with deficiency syndrome such as deficiency of both qi and blood,deficiency of cold of spleen and stomach is high,but there is no significant difference in disease-free survival between different syndrome types.5.Pathological stage ?,positive vascular tumor thrombus,positive surgical margin and high rate of positive lymph nodes were independent risk factors for disease-free survival after radical gastrectomy.6.Exploratory study found that the critical value of positive lymph node ratio for predicting recurrence and metastasis of gastric cancer after radical operation was 0.16.The disease-free survival time of patients with positive lymph node ratio?0.16 was significantly shorter than that of patients with positive lymph node ratio<0.16.It has reference significance for evaluating the risk of recurrence and metastasis and guiding postoperative adjuvant treatment,and is worthy of further study. |
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