| Objective:To provide a new treatment for intermediate-advanced Hepatocellular Carcinoma(HCC)patients,we compare of the efficacy and safety of large and drastic Formula and sorafenib via cohort study clinical research methods.Methods:By means of cohort study methods,according to the random matching principle,80 standard cases were divided into two groups: sorafenib group with 40 cases and large and drastic Formula with 40 cases.All of these cases come from Affiliated Hospital of Chengdu University of T.C.M,Infectious Department.sorafenib group was given oral sorafenib 400 mg,twice a day;arge and drastic Formula group was given large and drastic Formula,modified large and drastic Formula according to T.C.M differentiation.The patients were followed up and monitored blood routine,AFP,liver function,renal function,electrolyte and other indicators of serum and upper abdominal MRI every month.Based on Child-Pugh classification standard,we evaluated liver reserve function;The quality of life was assessed by the internationally recognized quality of life scale(QLQ-C30);TCM syndrom integral rating scale was adopted to evaluate the change of patients’ syndrome conditions;According to the RECIST evaluation criteria to assess the tumor and record disease progression and survival period timely;on the basis of the national drug adverse reaction schedule,the adverse reactions during the study were recorded to evaluate the safety of the drug.Results:1.Group conditions:80 patients were involved in this clinical study,including the treatment group and the control group,each with 40 cases.There is no significant statistical difference in age、gender、cause of disease、indicators of serum(liver function、AFP)、score of general healthy status 、Barcelona Clinical stage of liver cancer(BCLC)and TCM syndrom integral rating scale.2.Kaplan-meier method was adopted to analyse disease progression and survival period of two groups.The results showed that the median time to progression(m TPP)from patients who received large and drastic Formula is 9.0 months,while sorafenib only is 3.6 months(P<0.01).It suggested that median time to progression of intermediate-advanced hepatocellular carcinoma patients who used large and drastic Formula was prolonged significantly comparing to using sorafenib only.Patients’ survival curve showed that medium survival time in traditional chinese medicine group is 13.8 months,single drug sorafenib group is 6.0months.The difference between two groups has statistically ignificance.Suggesting that medium survival time of intermediate-advanced hepatocellular carcinoma patients can be prolonged by large and drastic Formula.In treatment group,tumor objective remission rate of patients is much better than control group.(35.0%VS 12.5%,P<0.05);Tumor disease control ratio is higher than control group.(92.5%VS 50%,P<0.05),Indicating that tumor objective remission rate and disease control ratio in treatment group are improved definitely.3.Comprison of serum indicator :AFP level in serum was compared between two groups before treatment and after treatment.The results showed the serum AFP levels in the treatment group and the control group were significantly lower than before,the difference has statistically significance.The difference of serum AFP between the two groups before and after treatment(difference= serum AFP level before treatment-after treatment)was compared,the serum AFP level of the treatment group decreased more obviously than that in control group,the difference has statistically significace.Patients’ liver function like serum ALT、TBIL and ALB was also compared.According to our statistics,serum ALT and TBIL level decreased in the same group before and after treatment;and also decreased in the treatment group and control group after treatment.The difference has statistically significant.However the serum level of ALB was increased after treatment in both groups,the difference has tatistically significant.In conclusion,after the treatment,the serum AFP level of two groups patients with liver cancer were decreased obviously,and the decreased range of serum AFP level in the treatment group significantly higher than the control group;after treatment the liver function of patients were improved in varying degrees both groups.4.Child-Pugh grade comparison for liver reserve function: Most of Child-Pugh grade of our patiens in groups are A and B.After treatment,the improvement of these indicators like total bilirubin(TBIL)、albumin(ALB)、prothrombin time(PT)、ascites and hepatic encephalopathy(HE)have no significant difference,all P>0.05.It suggesting that the Child-Pugh grade after treatment of both groups without remarkable difference.5.Quality of life(QOL)analysis showed that the quality of life score before and after treatment was compared between the two groups(quality of life score difference = quality of life score after treatment-quality of life score before treatment).In the function field,the treatment group in the physical,emotional and social function score was significantly better than the control group(P<0.05),while in the role,cognitive score had no difference between the two groups(all P>0.05);In symptoms field,there was no significant difference between the two groups(all P>0.05)of constipation,insomnia,pain and economic difficulties.While the rest of the symptoms in the treatment group is much better than the ontrol group(P<0.05);In the general health field,the score of the treatment group was higher than that of the control group(P<0.05).indicating the overall quality of survival in the treatment group after treatment is better than the single drug sorafenib group(control group),large and drastic Formula combined with sorafenib on the quality of life is much better than the control group.6.As for safety,through the analysis of the incidence rate of toxic and side effect in two groups,the incidence rate of diarrhea,fatigue,rash remarkably lower than control group(all P<0.05).Conclusion:1.Comparing with single drug sorafenib,large and drastic Formula can improve the disease control ratio of hepatocellular carcinoma patients and prolonged survival period.2.large and drastic Formula can significantly improve survival quality of intermediate-advanced hepatocellular carcinoma patients.3.large and drastic Formula can improve patients’ liver function.This combined treatment is safe and effective. |
PDF Full Text Request