Clinical Observation Of Fuzheng Xiaoji Formula In Preventing And Treating Early Recurrence Of Primary Liver Cancer After Radical Resection

Objective: To observe the clinical efficacy and safety of Fuzheng Xiaoji formula in the prevention and treatment of early recurrence after radical resection of primary liver cancer(liver depression and spleen deficiency,qi stagnation and blood stasis type),so as to provide an effective drugs and methods for the prevention and treatment of early recurrence of primary liver cancer with traditional Chinese medicine.Methods: Using the non-random open inclusion method,57 patients who met the inclusion criteria were divided into 28 patients in the control group and 29 patients in the observation group.The control group was treated with conventional western medicine,and the observation group was treated with Fuzheng Xiaoji formula on the basis of the former.The changes of TCM syndrome,nutritional status,recurrence free survival rate,quality of life,Karnofsky and alpha fetoprotein and liver function index were statistically analyzed to evaluate its efficacy and safety.Results:1.Curative effect of TCM syndrome in the two groups: after treatment,the syndrome scores of the two groups decreased(P < 0.05),and there was significant difference in the syndrome scores before and after the observation group(P < 0.01).The total effective rate of the control group before and after treatment was 42.9%,and that of the observation group was 65.5%,and the difference was not statistically significant(P >0.05).2.The improvement of nutritional indexes in the two groups: BW,BMI and ALB decreased slightly in the control group(P > 0.05),while BW,BMI and ALB increased slightly in the observation group(P > 0.05);After treatment,there was no significant difference in BW and BMI between the two groups(P > 0.05),and the level of ALB in the observation group was significantly higher than that in the control group(P < 0.05).3.Evaluation of recurrence free survival(RFS)rate: the one-year RFS in the control group was 75% and that in the observation group was 82.8%.There was little difference in RFS between the two groups during the treatment period(P > 0.05);After one year of follow-up,the RFS of the control group was 60.7% and that of the observation group was 72.4%.There was no significant difference in RFS between the two groups(P > 0.05).4.Improvement of quality of life and physical condition: there was no significant difference in QOL score before and after treatment in the control group(P > 0.05),but there was significant difference in QOL score before and after treatment in the observation group(P < 0.05).There was significant difference in QOL score between the two groups after treatment(P < 0.05);The improvement rate of physical condition in the control group was 35.7%,and that in the observation group was 62.1%.The difference was statistically significant(P < 0.05).5.Alpha fetoprotein and liver function indexes: AFP,ALT,AST,TBIL,ALPγ-GT indexes all decreased,ALT decreased significantly in the control group(P < 0.05),ALT and TBIL decreased significantly in the observation group(P < 0.05),and the other differences were not significant(P > 0.05);The decrease in the observation group was more than that in the control group,but the difference was not significant(P > 0.05).Conclusions: Fuzheng Xiaoji formula can improve the clinical symptoms,nutritional status,quality of life and physical condition of patients,and there is a tendency to reduce the rate of early recurrence.It is worthy of clinical application.