Clinical And Experimental Study Of ShenTao RuanGan Decoction On Medium And Late Stage Primary Liver Cancer

Objective:The purpose of clinical research is to observe the therapeutic efficacy of STRG on medium and late stage primary liver cancer,to prove if it can protect the hepatic function,According to the common traditional Chinese medicine adverse effect,mainly observe the effect of digestive system,renal function and cardiovascular system,then estimate it clinical effect and safety.The purpose of experimental research is to observe the pharmaceutical serum effect the inhibitory rate, cell cycle and the apoptosis genetic expression on hepatoma carcinoma cell(HCC)cell line,then discuss the possible mechanism.Methods:Clinical research:Collected 60 eligible patients with stageⅢ-Ⅳliver cancer were divided randomly into two group,as STRG treated group and Huaier Drop control group,each group has twenty patients.The two groups accepted the same supporting treatment.Meanwhile,the treated group were treated with STRG,one dose per day,last 40 days,the control group were treated with Huaier Drop,one pack every time,three times one day,last 40 days.The therapeutic efficiency and adverse effect of the two groups were evaluated after curing 40 days,then estimate it clinical effect and safety.Experimental research:9 New-Zealand male rabbit were randomly divided into three groups,treated group,blank serum group and positive group,three in each group.The treated group fed with STRG more than 10 times adult oral dose by gavages.The blank serum group fed with the partes aequlaes normal sodium by gavages.The positive group fed with 5-FU by gavages,the dose was 41.67mg/kg/day. All the groups fed three days,twice every day.Three groups boosted the same dose after two hours in the third day,etherization after one hour.75%alcohol sterilizes, from the heart cull blood,asepsis bolter blood serum,all the same groups blood serum were mixed uniformity.Afer waterbath inactivate disposal,put them in the refrigerator below zero 20.HCC cell line was had an inoculation RPMI 1640 culture fluid that contained 10%new-born calf serum and some antibiotics.The cultivation environment was 5%CO2,37℃and saturation humidity.The cell was cultivated three or five days,then passaged after trypsin digestion adequacy.The inhibiting rate of cells observed by MTT,the cell apoptosis and period were measured by Flow Cytometry(FCM),bcl-2 and p53 gene expression were measured by ELISA,in order to discuss STRG the possible mechanism.Results:STRG has the function of invigorate the spleen and support the liver, heat-clearing and detoxicating,cool the blood and removing blood stasis,Clinical research shows STRG has stabilized the tumor,improved KPS score and the patients symptoms,especially improve hepatic region pain,abdominal distention, anorexia,hypodynamia better.This effect could have concerned with prevent ALB and PA from descending.By drug adverse reaction,a few patients had some nausea and temporary vomiting,but no need treatment,they all could relieve,not found cardiovascular system and other systems adverse reaction.It proved STRG was safety. Experimental research shows that STRG has the inhibitory on HCC cell line growth, and the dose increasing more,the function enhancement more,the inhibitory rate on tumor growth of the high density pharmaceutical serum group was significant than the no pharmaceutical serum group,which inhibitory rate reached 43.2%,and the inhibitory rate on tumor was enhanced following the dose and time increasing,48 hour reached the peak,more significant than the blank group(P＜0.01).The high, middle and low density pharmaceutical serum of STRG had inhibited to mutant P53 and bcl-2.Compared with the positive group and the blank group,three density had more significant(P＜0.01 and 0.05).There were no significant between the pharmaceutical serum and the positive group or the blank group to bcl-2,but the pharmaceutical serum figure had lower tendency,the middle density had better effect. STRG could induce apoptosis,apoptosis rate reached 15.6%,and hold cell proliferation up G0/G1 stage.It proved that STRG could induce apoptosis,inhibit mutant P53 and bcl-2,which had anticancer function by this possible mechanism possibly.Conclusion:STRG has the function of invigorate the spleen and support the liver, heat-clearing and detoxicating,cool the blood and removing blood stasis,STRG has stabilized the tumor,improved KPS score and the patients symptoms,especially improve hepatic region pain,abdominal distention,anorexia,hypodynamia better. This effect could have concerned with prevent ALB and PA from descending.By drug adverse reaction,a few patients had some nausea and temporary vomiting,but no need treatment,they all could relieve,not found cardiovascular system and other systems adverse reaction.It proved STRG was safety.STRG has the inhibitory on HCC cell line growth,and the inhibitory rate on tumor was enhanced following the dose and time increasing,The high,middle and low density pharmaceutical serum of STRG had inhibited to mutant P53 and bcl-2.STRG could induce apoptosis,and hold cell proliferation up G0/G1 stage.The results of experimental research showed that STRG had the effect of inhibitory rate on tumor,inhibited to mutant P53 and bcl-2, induce apoptosis,which would be the partial mechanism of STRG in fighting the PLC and offered the theory foundation to clinical applying.