| Objective:In the way of systematic review and meta-analysis,the study was to evaluate the clinical efficacy of Jianpi formula in the treatment of colorectal cancer and the reduction of adverse effects of chemotherapy,and to explore the efficacy and value of Jianpi formula.The study is also aimed to provide reference for the clinical prescriptions of traditional Chinese medicine(TCM)in the treatment of colorectal cancer in evidence-based methods.Methods:A comprehensive search of Chinese and English databases was conducted on February 1,2020.The main databases searched for literature include:Chinese Biomedical Literature Database(CBM),VIP,China National Knowledge Infrastructure(CNKI),Wanfang,Cochrane Central Register of Controlled trials(CENTRAL),Embase and PubMed.The exclusion and inclusion criteria was concerned when literature screened.Meta-analysis was performed based on Review Manager 5.3 software.The analysis results were exported in the form of graph,such as forest plots and funnel plots,to clarify the efficacy and safety of Jianpi formula combined with chemotherapy in the treatment of colorectal cancer.Results:A total of 48 literatures were included in this systematic review,involving 3471 patients.The main outcomes of meta-analysis were:progression-free survival(PFS),overall survival(OS),objective response rate(ORR),disease control rate(DCR),and TCM syndrome remission rate.Secondary outcomes were:tumor markers CEA,CA199 and KPS scores;The safety outcomes were:the incidence of leukopenia,the incidence of thrombocytopenia,the incidence of vomiting and the incidence of liver dysfunction.The results analyzed by Revman5.3 are as follows:1.Survival:The PFS of the treatment group was longer than that of the control group(HR=0.66,95%CI:[0.54,0.80],P<0.0001,and the results were stable.The OS was longer than the control group(HR=0.66,95%CI:[0.52,0.83],P=0.0004),with stable results.2.Objective efficacy:The ORR in the treatment group was higher than that in the control group(RR=1.39,95%CI:[1.21,1.58],P<0.00001),with stable results and no significant publication bias.The DCR of the treatment group was higher than that of the control group(RR=1.23,95%CI:[1.16,1.31],P<0.00001),and the results were stable without significant publication bias.3.TCM syndrome remission rate:The TCM syndrome remission rate in the treatment group was higher than that in the control group(RR=1.53,95%CI:[1.42,1.66],P<0.00001),with stable results and potential publication bias.4.Tumor markers:No significant difference was showed between the treatment group and the control group in the reduction of CEA.(SMD=-0.06,95%CI:[-0.20,0.08],P=0.37),with stable results and potential publication bias;The reduction of CA199 after treatment showed no significant difference between the treatment group and the control group(SMD=-0.05,95%CI:[-0.22,0.13],P=0.60),and the results were stable without obvious publication bias.5.KPS scores:The KPS scores advance rate in the treatment group was higher than that in the control group(RR=1.72,95%CI:[1.48,1.98],P<0.00001),with stable results and potential publication bias.6.Safety outcomes:The incidence of leukopenia in the treatment group was lower than that in the control group(RR=0.69,95%CI:[0.63,0.75],P<0.00001),the results were stable,and might exist publication bias.The incidence of thrombocytopenia in the treatment group was lower than that in the control group(RR=0.68,95%CI:[0.59,0.79],P<0.00001),with stable results and no significant publication bias;The incidence of vomiting in the treatment group was less than that in the control group(RR=0.62,95%CI:[0.48,0.79],P=0.0001),and the results were stable without significant publication bias.The incidence of liver dysfunction in the treatment group was lower than that in the control group(RR=0.65,95%CI:[0.54,0.79],P<0.0001),and the results were stable without significant publication bias.Conclusion:1.Compared with simple chemotherapy,Jianpi formula combined with chemotherapy can give more the survival benefit to colorectal cancer patients and prolong both PFS and OS.2.Jianpi formula can improve objective efficacy of colorectal cancer patients receiving chemotherapy,and has a great effect in the shrinkage of tumor.3.Jianpi formula can significantly mitigate the clinical syndromes of colorectal cancer patients receiving chemotherapy,alleviate the patients' symptoms and raise their quality of life.4.Jianpi formula did not significantly reduce the tumor markers CEA and CA199 in colorectal cancer patients undergoing chemotherapy.However,the value of tumor markers in each study was quite different.Therefore,the results of this study are just for reference and need further verified.5.Jianpi formula can significantly enhance the functional status of colorectal cancer patients undergoing chemotherapy and significantly strengthen their physical agility.6.Jianpi formula can effectively reduce the adverse effects of chemotherapy such as myelosuppression,vomiting and hepatic dysfunction and improve the safety of chemotherapy.7.Compared with simple chemotherapy,Jianpi formula combined with chemotherapy has better clinical efficacy and greater safety,which is worth wider clinical application and further research. |
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