Objective: To observe the clinical efficacy and safety of Ganxi tablet combined with Aidi injection in the treatment of advanced primary liver cancer(liver stasis and spleen deficiency type),and to provide an effective method for the comprehensive treatment of advanced liver cancer in traditional Chinese medicine.Methods: 60 patients with stage C ? D primary liver cancer(liver stasis and spleen deficiency type)were divided into treatment group and control group by random digital table method.the treatment group was treated with liver xi tablet edi injection and the best support treatment.the control group was treated with only the best support treatment,and the two groups were treated with 28 days for 1 cycle and 3cycles.by observing the physical condition,clinical symptoms,liver and kidney function,tumor marker level,progression-free survival,median survival and adverse reactions of the two groups,the above data were statistically analyzed by SPSS 22.0statistical software.Results:(1)card score: the total effective rate was 87% in the treatment group and27.58% in the control group.the effective rate of the two groups was statistically significant(P<0.05).(2)Clinical symptoms of TCM: the effective rate of treatment group(obviously,the ratio of partially improved cases to total cases)was 67.74%,the control group was 27.58%,the difference between the two groups was statistically significant(P<0.05).(3)Tumor markers(AFP ?CEA? CA-199): after the treatment group,the average water of tumor markers decreased compared with the previous treatment,before and after treatment by statistical test,there was statistical significance(P<0.05),the level of tumor markers after treatment in the control group was higher than before,after treatment by statistical test,there was statistical significance(P<0.05).(4)Progressive survival and median survival :107 days in the median PFS treatment group and 82 days in the control group,with no significant difference between the two groups(P>0.05)The MST of the treatment group was 224 days,the MTS of the control group was 148 days,and the difference between the two groups was statistically significant(P<0.05).(5)Liver and kidney function: the abnormal rates of total bilirubin,alanine aminotransferase,alkaline phosphatase and urea nitrogen in treatment group were 35.4%,19.3%,45.1% and 25.8%,respectively,and 72.4%,62%,79.3% and 34.4% in control group.The difference was statistically significant(P<0.05).(6)Safety: There was no significant difference in ECG,rash and fever before treatment between the two groups,and there was difference in ECG grading after treatment between the two groups statistical significance(P<0.05).Before and after treatment,there was no significant difference between the two groups(P>0.05).Conclusion: Aidi injection combined with Ganxi tablet in the treatment of advanced primary liver cancer with liver stasis and spleen deficiency can improve patients' KPS score,improve clinical syndromes,improve quality of life,prolong median survival time,reduce tumor marker level,protect liver and kidney function,and have better safety.This scheme can provide some ideas for TCM comprehensive treatment of advanced liver cancer. |