Medication regularity and effect of Fuzheng Qingdu therapy for survival of patients with gastric cancer based on real world evidence
Objective:To evaluate the clinical efficacy of Fuzheng Qingdu therapy(FZQDT)in the treatment of gastric cancer(GC)in the real world environment and analyze its medication rules.Methods:The clinical data of GC patients who met the inclusion and exclusion criteria in Hospital information system of multi-center from March 1,2012 to June 30,2022 were collected.Real world study was conducted.The patients were divided into the Traditional Chinese Medicine(TCM)group and the control group according to whether they received FZQDT or not.Cox regression model was used to analyze the survival prognosis.Kaplan-Meier survival curve and log-rank test were used to compare overall survival(OS)and progress-free survival(PFS).Microsoft Excel 16.0,SPSS Modeler 18.0 and Cytoscape 3.9.1 was used to carry out statistics of frequency,association rules and cluster analysis of prescription herbs respectively.Results:The total of 479 enrolled GC patients were divided into TCM group(n=200)and control group(n=279).The result of prognostic analysis showed that the TCM treatment of FZQDT was an independent protective factor for OS of GC patients(P<0.001).The median of OS(37.30 months vs.12.77 months,HR=0.38,P<0.001)and PFS(26.80 months vs.10.03 months,HR=0.59,P<0.001)of TCM group were significantly longer than those of control group.Subgroup analysis showed that the OS of GC patients,regardless of TNM stage and surgical history,in TCM group were longer than those in the control group(P<0.05).The total of 200 prescriptions and 180 herbs were included.There were 16 core herbs with utilization rate ≥50%,such as Glycyrrhiza uralensis Fisch,Astragalus membranaceus(Fisch)Bunge.Ten pairs of two herbs with support rate>35% and confidence rate>95%,such as Perilla frutescens(L)Britton-Agastache rugo-sa(Fisch.et Mey.)O.Kuntze,were found.The results of cluster analysis showed that the core herbs could be clustered into 6 categories.Conclusion:FZQDT is consistent with the pathogenesis of"spleen deficiency and toxic accumulation"of GC."Fuzheng"emphasizes spleen strengthening,followed by liver nourishing."Qingdu"focu-ses on removing"water poison",followed by"food poison"and"heat poison".FZQDT could prolong the survival of GC patients in the real world,the core herbs of which were Glycyrrhiza uralensis Fisch,Astragalus membrana-ceus(Fisch)Bunge,Poria cocos(Schw.),etc.
gastric cancersurvival timeFuzheng Qingdu therapymedication regularityreal world