The Clinical Effect Of Shen Tao Ruan Gan Tablet On The Patients Of Hepatocarcinoma And Experimental Study Of Shen Tao Ruan Gan Tablet On Hepatoprotection

ObjectiveTo observe the clinical effect of Shen Tao Ruan Gan Tablet on the patients of Hepatocarcinoma and the Hepatoprotective effect of Shen Tao Ruan Gan Tablet on BALB/c mice.MethodClinical research:According to 2011 China guidelines of liver cancer, 80 patients with hepatocarcinoma had been collected by inclusive criteria, which include 40 patients treated by TCM,40 patients treated by TCM and TACE. 40 patients treated by TCM were divided into two groups randomly, Treatment group 1 (n=20), control group 1 (n=20).40 patients treated by TCM and TACE were divided into two groups randomly, Treatment group 2 (n=20), control group 2 (n=20). After recording the age, sex, TCM and KPS score. All of the patients were treated with general treatment. Treatment group were treated with Shen Tao Ruan Gan Tablet,6 tablets a time, thrice a day, for 12 weeks. Control group were treated with Huaier Drop,20g a time, thrice a day, for 12 weeks. To observe the change of Chinese syndrome, TCM curative effect score, western medicine curative effect score, KPS score, hepatoprotective effect,tumor marker, Ts/Ts, NK cell and safety. And according to the will of the patients, Treatment group were treated with Shen Tao Ruan Gan Tablet,6 tablets a time, thrice a day, for 36 weeks. Control group were treated with Huaier Drop,20g a time, thrice a day, for 36 weeks. To observe the PFS.Experimental Study:To observe the hepatoprotective effect of Shen Tao Ruan Gan Tablet on BALB/c mice.25 BALB/c mice hepatic injury models were established by injecting Concanavalin A, which had been devided into 5 groups, low dose group(n=5), middle dose group(n=5), high dose group(n=5), control group-Huaier Drop group(n=5) and positive control(n=5). Low dose group was treated with Shen Tao Ruan Gan Tablet,0.5 tablets a time, once a day, for 3 weeks. Middle dose group was treated with Shen Tao Ruan Gan Tablet,1 tablets a time, once a day, for 3 weeks. High dose group was treated with Shen Tao Ruan Gan Tablet,2 tablets a time, once a day, for 3 weeks. Control group-Huaier Drop groupwas treated with Shen Tao Ruan Gan Tablet,1 tablets a time, once a day, for 3 weeks. To observe the change of the weight of the mice, the hepatoprotective effect, and rehabilitation of liver cell.Result1. Clinical Effect:①The treatment group could improve TCM curative effect score. The total effective rate of treatment group 1 was 35%, the total effective rate of control group 1 was 25%, which were significantly different from control group (P=0.004). The total effective rate of treatment group 2 was 40%, the total effective rate of control group 1 was 30%, which were significantly different from control group (P=0.024).②Shen Tao Ruan Gan Tablet probably could take advantage of hepatoprotective effect. The stability ratio of treatment group 1 was 55%, the stability ratio of control group 1 was 40%, The stability ratio of treatment group 2 was 55%, the stability ratio of control group 2 was 45%. Western medicine curative effect have the upward tendency, but there is no significantly different between the treatment group and control group.③The treatment group could improve the syndrome of TCM score. Treatment group 1 were significantly different from before treatment (P=0.003). Treatment group 2 were significantly different from before treatment (P<0.001). Treatment group 1 were significantly different from control group 1 (P=0.003). Treatment group 2 were significantly different from contro group 2(P<0.001).④The treatment group could improve the syndrome of KPS score. The treatment group could improve the syndrome of TCM score. Treatment group 1 were significantly different from before treatment (P=0.017). Treatment group 2 were significantly different from before treatment (P=0.017). Treatment group 1 were significantly different from control group (P=0.028). Treatment group 2 were significantly different from control group 2(P=0.034).⑤Shen Tao Ruan Gan Tablet maybe can make the tumor more stable, the tumor change of treatment group 1 were significantly different from control group (P=0.038). the tumor change of treatment group 2 were significantly different from control group (P=0.038).⑥Shen Tao Ruan Gan Tablet could probably lengthen PFS, but there is no significantly different between the treatment group and control group.2. Tumor Marker:①Shen Tao Ruan Gan Tablet maybe can make the AFP more stable. There were 10 AFP-positive patients in treatment group 1,9 AFP-positive patients in control group 1,17 AFP-positive patients in treatment group 2,16 AFP-positive patients in control group 2. The AFP stability ratio of treatment group 1 was 40%, the stability ratio of control group 1 was 33.3%, The stability ratio of treatment group 2 was 52.9%, the stability ratio of control group 2 was 43.8%. AFP have the decrease tendency, but there is no significantly different between the treatment group and control group.②Shen Tao Ruan Gan Tablet probably could take advantage of AFU. Treatment group 1 were significantly different from before treatment (P<0.001). Treatment group 2 were significantly different from before treatment (P<0.001). Treatment group 1 were significantly different from control group 1 (P<0.001). Treatment group 2 were significantly different from control group 2(P=0.005).3. Hepatoprotective Effect on Patients:①Shen Tao Ruan Gan Tablet probably could take advantage of Child-Pugh score. Treatment group 1 were significantly different from before treatment (P=0.029). Treatment group 2 were significantly different from before treatment (P=0.024). Treatment group 1 were significantly different from control group 1 (P=0.037). Treatment group 2 were significantly different from control group 2(P<0.001).②Shen Tao Ruan Gan Tablet probably could reduce ALT. Treatment group 1 were significantly different from before treatment (P<0.001). Treatment group 2 were significantly different from before treatment (P<0.001). Treatment group 1 were significantly different from control group 1(P=0.037). Treatment group 2 were significantly different from control group 2(P=0.001).③Shen Tao Ruan Gan Tablet probably could take advantage of PA. Treatment group 1 were significantly different from before treatment (P<0.001). Treatment group 2 were significantly different from before treatment (P<0.001). Treatment group 1 were significantly different from control group 1 (P=0.037). Treatment group 2 were significantly different from control group 2(P<0.001).④Shen Tao Ruan Gan Tablet probably could take advantage of TPA. Treatment group 1 were significantly different from before treatment (P=0.022). Treatment group 2 were significantly different from before treatment(P=0.032). Treatment group 1 were significantly different from control group 1 (P=0.042). Treatment group 2 were significantly different from control group 2(P<0.008).⑤Shen Tao Ruan Gan Tablet probably could take advantage of CHE. Treatment group 1 were significantly different from before treatment (P<0.001). Treatment group 2 were significantly different from before treatment(P=0.011). Treatment group 1 were significantly different from control group 1 (P=0.007). Treatment group 2 were significantly different from control group 2(P=0.001).4. Immune Indexes:(DShen Tao Ruan Gan Tablet probably could take advantage of Th/Ts. Treatment group 1 were significantly different from before treatment (P=0.024). Treatment group 2 were significantly different from before treatment(P=0.002). Treatment group 1 were significantly different from control group 1 (P=0.001). Treatment group 2 were significantly different from control group 2(P=0.001).�'hen Tao Ruan Gan Tablet probably could take advantage of NK cells. Treatment group 1 were significantly different from before treatment (P<0.001). Treatment group 2 were significantly different from before treatment(P=0.002). Treatment group 1 were significantly different from control group 1 (P=0.004). Treatment group 2 were significantly different from control group 2(P=0.005).5. Hepatoprotective Effect on hepatic injury model:①Shen Tao Ruan Gan Tablet probably could take advantage of ALT of the hepatic injury model. Low dose group were significantly different from before treatment(P=0.003). Middle dose group, high dose group were significantly different from before treatment (P<0.001). Middle dose group, high dose group were significantly different from control group(P<0.005).②Shen Tao Ruan Gan Tablet probably could take advantage of AST of the hepatic injury model. Low dose group, middle dose group, high dose group were significantly different from before treatment(P<0.001). Middle dose group, high dose group were significantly different from control group (P<0.005).③Shen Tao Ruan Gan Tablet can improve weight of the hepatic injury model, which were significantly different from control group (P<0.05).④Tao Ruan Gan Tablet can rehabilitate of liver cell, which were significantly different from control group (P<0.05)6.Security:Shen Tao Ruan Gan Tablet is safety. There was no significantly different between the two groups in kidney injury. There was little adverse reaction during the research.Conelusion①Shen Tao Ruan Gan Tablet in treating hepatocarcinoma is effective; there are advantage in releasing syndrome of TCM, improving KPS score, making the tumor marker more stable, lengthen PFS.②Shen Tao Ruan Gan Tablet probably could take advantage of Child-Pugh score, ALT, PA, TPA,CHE in patients. Shen Tao Ruan Gan Tablet probably could take advantage of ALT and ALT of the hepatic injury model. Shen Tao Ruan Gan Tablet can improve weight of the hepatic injury model. Shen Tao Ruan Gan Tablet can rehabilitate of liver cell.③Shen Tao Ruan Gan Tablet probably could take advantage of Th/Ts and NK cells.④The mechanism is probable in the function of hepatoprotective effect, and rehabilitation of liver cell.