| Objective:(1)To explore the efficacy and safety of traditional Chinese medicine combined with chemotherapy in the prevention and treatment of postoperative recurrence and metastasis of locally advanced gastric cancer(LAGC)by meta-analysis,and to evaluate the efficacy of traditional Chinese medicine on quality of life,immune indexes,toxic and side effects during adjuvant chemotherapy,as well as the prevention and treatment of recurrence and metastasis after LAGC.(2)To analyze the influence of clinical data on disease-free survival(DFS)after LAGC,and screen out the risk factors and protective factors of multiple related factors including TCM Intervention on DFS after LAGC,so as to provide ideas for the better application of TCM in the prevention and treatment of recurrence and metastasis after LAGC in the future.Methods:(1)CNKI,Wanfang,VIP,PubMed,Cochrane Library and other databases were searched by computer until February 2021.Randomized controlled trials(RCTs)related to"prevention and treatment of recurrence and metastasis of gastric cancer with traditional Chinese medicine" were searched.The study population was LAGC patients who had undergone standard radical gastrectomy.The control group was treated with standard postoperative chemotherapy for more than 4 cycles,On the basis of the control group,the treatment group was treated with traditional Chinese medicine for more than 8 weeks.The outcome measures included recurrence and metastasis rate,DFS,immune function,quality of life and adverse reactions.The research literature screening and data extraction.The Review Manager 5.3 software provided by Cochrane was used for meta-analysis.(2)The general data,clinical disease data and TCM treatment data of LAGC patients treated with TCM in 4 hosptials within 2 years after operation were collected,The relevant data of all variables in the baseline data were statistically described.The results were analyzed according to the location,stage and operation method of the primary lesion.Kaplan Meier method was used in univariate analysis to screen out the factors related to postoperative DFS(P<0.05)for recurrence and metastasis curve,and then the related factors were included in Cox risk regression model for multivariate analysis to screen out the independent risk factors and protective factors of postoperative DFS.Results:(1)A total of 18 RCTs were included.Meta analysis showed that compared with chemotherapy alone,traditional Chinese medicine combined with chemotherapy could improve KPS score(MD=7.24,95%CI[5.17,9.31],P<0.00001),CD3+index level(MD=9.52,95%CI[5.90,13.15],P<0.00001)and CD4+/CD8+index level(MD=0.49,95%Cl[0.32,0.66]),The incidence of postoperative leucopenia(RR=0.55,95%CI[0.35,0.86],P=0.01),hemoglobin reduction(RR=0.60,95%CI[0.39,0.93],P=0.02),thrombocytopenia(RR=0.70,95%CI[0.57,0.87],P=0.001),nausea and vomiting(RR=0.54,95%CI[0.41,0.70],P<0.00001)and diarrhea(RR=0.61,P<0.00001)were reduced,95%CI[0.46,0.81],P=0.0007),incidence of neurotoxicity(RR=0.42,95%CI[0,19,0.93],P=0.03).In terms of postoperative QLQ-C30 score(MD=7.22,95%CI[-8.54,22.98],P=0.37),abnormal liver function(RR=0.67,95%CI[0.29,1.58],P=0.37)and abnormal renal function(RR=0.57,95%CI[0.17,1.90],P=0.36),the incidence of TCM combined chemotherapy was similar to that of chemotherapy alone,with no statistical difference;Compared with chemotherapy alone,TCM combined chemotherapy can reduce the 1-year cumulative recurrence and metastasis rate(RR=0.61,95%CI[0.44,0.85],P=0.003),2-year cumulative recurrence and metastasis rate(RR=0.62,95%CI[0.44,0.86],P=0.005),3-year cumulative recurrence and metastasis rate(RR=0.59,95%CI[0.48,0.73],P<0.00001),The 5-year cumulative recurrence and metastasis rate(RR=0.60,95%CI[0.38,0.95],P=0.03)and the disease-free survival time(MD=2.61,95%CI[1.38,3.83],P<0.0001)were prolonged.(2)A total of 62 patients who met the inclusion criteria were included in the clinical study,including 6 cases of abscission,and finally 56 cases entered the statistical analysis.As of February 2021,all the 56 patients with LAGC had reached the 2-year observation period after operation.Recurrence or metastasis occurred in 3 patients within 1 year after operation,and the cumulative recurrence and metastasis rate was 5.35%;Recurrence or metastasis occurred in 16 patients within 2 years after operation,and the cumulative recurrence and metastasis rate was 28.57%.As of February 2021,32 cases of recurrence and metastasis occurred in 56 patients after LAGC,accounting for 57.14%.The results showed that the recurrence/metastasis time of 32 patients ranged from 9 to 70 months,with an average of 28.72 months ±78 months,the median DFS was 24 months.? Univariate Cox regression showed that TNM stage(95%CI:0.21-0.97,P=0.041),postoperative serum albumin level(95%CI:0.18-0.96,P=0.04)and TCM treatment<1 year(95%CI:3.77-20.02,P<0.001)were the influencing factors of postoperative DFS.? Multivariate Cox regression showed that IB-II stage(compared with III stage)was an independent protective factor for postoperative DFS(95%CI:0.119-0.712,P=0.007),and TCM treatment time<1 year was an independent risk factor for postoperative DFS(95%CI:3.587-23.631,P<0.0001).Conclusion:(1)Meta analysis:comparing the efficacy of traditional Chinese medicine combined chemotherapy with chemotherapy alone in adjuvant chemotherapy,the immune level and KPS score of patients after LACC can be improved,and the incidence of leucopenia,hemoglobin reduction,thrombocytopenia,nausea and vomiting,diarrhea and neurotoxicity can be reduced.There was no significant difference between QLQ-C30 score and the incidence of liver and kidney dysfunction compared with chemotherapy alone;In the long-term prevention and treatment of recurrence and metastasis,the recurrence and metastasis rate of LAGC can be reduced and DFS can be improved.(2)Clinical study:under the combination of traditional Chinese medicine and chemotherapy,earlier TNM stage(IB-II stage)and longer dialectical treatment time(more than 1 year)are independent protection factors of DFS after LAGC. |
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