| ObjectiveThis study is to observe the clinical effect of Shen Tao Ruan Gan Tablet(empirical prescription from Prestigious Prof.Daihan Zhou)combined with Transcatheter Hepatic Arterial Chemoembolization(TACE)in the treatment of primary liver cancer in stage B and C of Barcelona staging(BCLC),through a randomized controlled prospective study,to explore the effect of Shen Tao Ruan Gan Tablet on easing clinical symptoms,improving the quality of life,and hepatoprotecetion.Furthermore,to have a deep thought in the use of the idea of combining strengthen body resistance and eliminate pathogenic factors,the unity of the whole and the part in the treatment of cancer represented by Shen Tao Ruan Gan Tablet.MethodsAccording to the inclusion and exclusion criteria,62 eligible advanced hepatocarcinama patients selected from the First Affiliated Hospital of Guangzhou University of Chinese Medicine,were randomly divided into two groups-experimental group and control group,each group has 31 patients.The treatment method of the experimental group patients is combing Shen Tao Ruan Gan Tablet with TACE,the control group only treated with TACE.The shortest course of treatment was 4 weeks,the longest course of treatment can be up to 48 weeks.The incidence of embolism syndrome after TACE treatment was observed.The changes of TCM symptoms,liver function,immune index and tumor markers before and after the treatment were observed.The changes of tumor size were observed,and the rate of half a year survival and 1 year survival were analyzed statistically.ResultsThe frequency of nausea,anorexia,constipation symptoms after the TACE in the experimental group is less than the control group,the P values are 0.016,0.034,0.037,P<0.05,there is a significant difference;in comparison of the frequency of abdominal pain and fever symptoms,P values are 0.198,0.795,P>0.05,no significant difference.The Shen Tao Ruan Gan group may have advantages in easing the hypochondriac pain,eatingless,depression,belching,nausea and vomiting,loose stools,lassitude,emaciation,abdominal distension,dry stool,mouth pain,dry mouth,urine red,dizziness,insomnia and other symptoms,P values are less than 0.05,there is a significant difference.The total symptoms score of experimental group after treatment is improving than before,P<0.05,having a significant difference;the total symptoms score of control group after treatment have no obvious improvement than before treatment,P value is bigger than 0.05,having no significant difference;compared with the total score of TCM symptoms after treatment,the experimental group is better than the control group,P<0.05,there is a significant difference.After treatment,the total effective rate of the experimental group is 90%,while that of the control group is 60%,which is statistically significant.The results showed that there were differences between the two groups in the improvement of TCM symptoms and signs of the syndrome in the treatment group and the control group(P=0.007).The experimental group may have an advantage in reducing alanine aminotransferase(ALT),glutamic-oxalacetic transaminase(AST),gamma glutamyl transferase(GGT),total bilirubin(TB),albumin(ALB),prealbumin(PA)levels and Child-Pugh liver function grade than the control group,the P value is less than 0.05,have statistical difference.However,there was no significant difference between the two groups in reducing the level of LDH after treatment.The Shen Tao Ruan Gan group may have an advantage in reducing tumor marker alpha fetoprotein(AFP),alpha-L fucosidase(AFU)than the control group,P value is less than 0.05,have a statistical difference.BUT there is no statistical difference between the two groups in reducing carcinoembryonic antigen(CEA).The experimental group may have advantages in improving patients with total lymphocyte count(LYM)levels than the control group may have,P value is less than 0.05,have a statistical difference;but with the total number of white blood cells(WBC),the total number of neutrophils(NEU),the P value is greater than 0.05,there is no statistical difference.Compared with the control group,the experimental group has an advantage in improving the functional status of patients with Karnofsky(KPS)score,stabling tumor size,improving survival rate,P value was less than 0.05,there are statistically significant differences.In security side,there were no serious adverse reactions,except for 3 patients had a reaction of mild and transient nausea during the course of treatment,there were no hepatic encephalopathy and died patients in the two groups.ConclusionIn the effect of traditional Chinese medicine,Shen Tao Ruan Gan tablet may can reduce embolization syndrome,ease the symptoms of traditional Chinese medicine;in terms of western medicine efficacy,Shen Tao Ruan Gan tablet may can significantly reduce side effects and improve the quality of life,improve liver function,reduce tumor markers,stable the tumor and improve the survival rate of tumor,etc.Shen Tao Ruan Gan tablet’ s side reaction is small,the safety is high,the method is simple,and it is worthy of further clinical research and popularization. |
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