| Objective To explore the efficacy and safety of “Large and Drastic Formula” in the treatment of Hepatitis B associated intermediate-advanced hepatocellular carcinoma.Methods A retrospective cohort study was used to analyze the medical records of patients who were diagnosed with Hepatitis B associated intermediate-advanced hepatocellular carcinoma in Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Infectious Department during January 2012 to December 2017.Making the patients who were insisting on taking “Large and Drastic Formula” as an observation group(93cases),and the other patients who were insisting on taking “Sorafenib” as a control group(51 cases).All the cases were given symptomatic support treatment including liver protection,entecavir anti-virus treatment and human serum albumin,etc.Outcome indicator The evaluated indicators include: median survival time after treatment in both groups,median time to progression,survival rates after three months,six months,nine months,one year and two years.On the bases of RECIST 1.1 standard to evaluate the overall efficacy of patients,objective tumor remission rate and disease control rate after treatment.Compare the clinical symptom score of TCM within the group and between two groups.Evaluate the adverse reactions during the therapy.Results 1.A total of 185 cases were collected,in which144 cases were eligible,including observation group 93 cases and control group 51 cases.The baseline level was not statistically significant(P>0.05)between the two groups of patients before treatment and they were comparable.2.Both the median overall survival time and the median disease progression time in observation group were longer than those in the control group,and differences were statistically significant(P<0.01).3.The survival rate of the observation group was higher than that of the control group after three months,six months,nine months,one year and two years,and the differences were statistically significant(all P<0.05).4.After three months of treatment,the objective tumor remission rate and disease control rate in the observation group were both higher than those in the control group,and differences were statistically significant(P<0.01).5.After treatment,the clinical symptom scores in both groups decreased compared with those before treatment(P<0.01),and the observation group decreased more significantly(P<0.05).The difference was statistically significant.6.The incidence of adverse reactions in the observation group was lower than that in the control group,and the difference was statistically significant(P<0.05).Conclusion “Large and Drastic Formula” can not only significantly prolong the survival time and time to progression of patients with Hepatitis B associated intermediate-advanced hepatocellular carcinoma,but also improve survival rate and clinical symptoms.Therefore it is safe and effective in clinical use. |
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