| Objective: The effects of prescription for Fu He Bei Hua combined with TACE on related mechanism,short-term efficacy and safety in patients with advanced primary liver cancer were observed.Methods: Through a randomized and controlled clinical trial,105 patients with hepatocellular carcinoma were randomly divided into treatment group(n = 53)and control group(n = 52).Patients in the treatment group were treated with prescription for Fu He Bei Hua combined with TACE and the control group was treated with conventional TACE treatment.The short-term efficacy,postoperative embolism syndrome,expression levels of GLUT1,HK2,PMK2 d,PFS,AFP,KPS score and TCM syndrome score were observed and compared between the two groups.Results:(1)Short-term efficacy: The objective response rate 48.0% and disease control rate was 94.0% in the treatment group;The objective response rate was 40.0% and the disease control rate was 84.0% in the control group,there was no significant difference between the two groups(P > 0.05).(2)Postoperative embolism syndrome: There were no cases of severe or fatal embolism syndrome in the two groups,and the incidence of gastrointestinal reactions such as fever and malignant vomiting and transient liver cell damage in the treatment group was significantly lower than that in the control group(P < 0.05).(3)Glucose metabolizing-related protein levels: GLUT1,HK2 and PMK2 levels in peripheral blood of the two groups after 12 weeks of treatment were lower than before(P < 0.05),and the levels in the treatment group were significantly better than that in the control group after 12 weeks of surgery(P < 0.05).(4)PFS: The median PFS was 9.2 months in the treatment group and 7.0months in the control group,there was no significant difference between the two groups(P > 0.05).(5)AFP level: AFP level was decreased in both groups after TACE(P <0.05),and the treatment group was significantly better than the control group(P < 0.05).(6)KPS score: KPS score 12 weeks after operation was improved in both groups(P < 0.05),and the treatment group was better than the control group(P < 0.05).(7)TCM syndrome scores and total scores related to liver depression and spleen deficiency in both groups 12 weeks after surgery were significantly lower than those 1 day before surgery(P < 0.05);Moreover,the TCM syndrome scores and total scores related to liver depression and spleen deficiency in the treatment group were significantly lower than those in the control group at the same period(P < 0.05).(8)Safety: There were no serious adverse reactions related to the study occurred in the two groups.The treatment group was superior to the control group in terms of adverse reactions such as fever and temporary impairment of liver cell function(P < 0.05),and there was no significant change in laboratory examination results before and after treatment.Conclusion(s): Compared with conventional TACE in the treatment of patients with primary liver cancer in middle and advanced stage,Prescription for Fu He Bei Hua combined with TACE can effectively relieve postoperative embolism syndrome,TCM syndromes and improve the quality of life of patients.It can also down-regulate the expression levels of GLUT1,HK2 and PMK2 in peripheral blood serum 12 weeks after operation,which is worthy of further study. |