Objective

2

To observe the effects of

Huqi Zhengxiao Formula

（槲芪癥消方） on the survival rate and quality of life of patients with stage Ⅲ hepatitis B-associated primary liver cancer （PLC） with syndrome of healthy

qi

deficiency and toxic stasis accumulation after transcatheter arterial chemoembolisation （TACE） treatment.

Methods

2

One hundred and twenty-six patients with stage Ⅲ hepatitis B-associated PLC who were identified as syndrome of healthy

qi

deficiency and toxic stasis accumulation after TACE treatment were selected， and were randomly assigned to 63 cases each of the treatment group and the control group in a ratio of 1∶1 by using the random number table method； the control group was given symptomatic supportive treatments with western internal medicine， and the treatment group was given the addition of

Huqi Zhengxiao Formula

on the basis of the control group. All patients were treated for a period of 48 weeks， and were followed up at weeks 4， 8， 12， 24， 36， and 48 of the treatment process. The primary effectiveness index was the 1-year survival rate， and the secondary effectiveness index was the Karnofsky score and the traditional Chinese medicine （TCM） syndrome score. Survival analysis was performed using the Kaplan-meier method， and Log-rank test was used to compare the differences between the survival curves of each group.

Results

2

Six withdrawals in the treatment group and seven withdrawals in the control group， and finally 57 patients in the test group and 56 patients in the control group were included in the statistical analysis. The 1-year survival rate of patients in the treatment group was 56.1% （32/57）， which was higher than that of 33.9% （19/56） in the control group （

P

= 0.033）. The mean survival time was （275.30±15.50） days in the treatment group， higher than （227.16±17.11） days in the control group （

P

= 0.039）. Thirty-two patients in the treatment group and 19 patients in the control group completed the Karnofsky score and TCM symptom score at each time point. At weeks 4， 8， 12 and 36， the difference in the Karnofsky score between the two groups was not statistically significant （

P

＞0.05）； at weeks 24 and 48， the Karnofsky score in the treatment group was higher than that in the control group at the same time point （

P

＜0.05）； analysis of variance of repeated measurements found that the downward trend of the Karnofsky score in the treatment group was slower than that in the control group （

F

= 4.47，

P

= 0.037）. The difference between the TCM symptom scores of the two groups at each follow-up observation point was not statistically significant （

P

＞0.05）； there was a tendency for the TCM symptom scores of the two groups to increase， but the ANOVA of repeated measurements found that the difference between the two groups was not statistically significant either （

F

= 0.31，

P

= 0.58）. Concusion The oral administration of

Huqi Zhengxiao Formula

can improve the survival rate， prolong the survival time， and improve the quality of life of patients with stage Ⅲ hepatitis B-associated PLC with syndrome of healthy

qi

deficiency and toxic stasis accumulations after TACE treatment.