Objective

2

To investigate the effect of

Fufang Banmao

Capsule

（复方斑蝥胶囊， FFBMC） combined with western medicine on the three-year survival of patients with primary liver cancer （PLC） and spleen deficiency and blood stasis syndrome.

Methods

2

Data on hospitalized patients with first PLC were retrospectively collected， and the patients were divided into western medicine group and FFBMC group according to whether FFBMC was additionally used. Western medicine group received surgical resection， minimally invasive therapy and palliative treatment according to the condition. Additionally， the FFBMC group took FFBMC （0.75 g per time， twice daily）for at least 3 months. Univariate and multivariate Cox regression analysis was conducted to explore the affecting factors of the 3-year survival of patients with PLC， including alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， total bilirubin （TBIL）， neutrophil-lymphocyte ratio （NLR）， platelet （PLT）， albumin （ALB）， prothrombin activity （PTA）， hemoglobin （Hb）， alpha-fetoprotein （AFP） ≥ 400 ng/ml， Child-Pugh grade， Barcelona Clinic Liver Cancer （BCLC）， taking FFBMC， western medicine type. The 3-year overall survival rate was compared between the two groups and between the different courses of FFBMC； the subgroup analyses in terms of different BCLC stages， different Child-Pugh grades， and hepatitis B type versus non-hepatitis B type were performed on the 3-year overall survival rate.

Results

2

A total of 406 cases were included， with 272 cases in the western medicine group and 134 cases in the FFBMC group showing imbalance baseline data between groups； after propensity score matching （PSM）， 117 cases in each group were matched obtaining comparability in critical baseline indicators. Univariate Cox regression analysis showed that AST， TBIL， NLR， PLT， ALT， ALB， PTA， Hb， AFP ≥ 400 ng/ml， Child-Pugh grades， BCLC staging， taking FFBMC， and western medicine type were the influencing factors of 3-year survival of PLC patients. Multivariate Cox regression showed that AST， TBIL， NLR， PLT， AFP≥400 ng/ml， Child-Pugh B/C grade， surgical resection， minimally invasive treatment， and taking FFBMC were independent influencing factors affecting the 3-year survival. Before PSM， the 3-year survival rate in the western medicine group was 30.5% （83/272）， while that of the FFBMC group was 74.6% （100/134）. After PSM， the 3-year overall survival rate in the wes-tern medicine group was 60.7% （71/117）， and the average three-year survival time was 25.17 months， while those of the FFBMC group were 74.4% （87/117） and 29.91 months， respectively. After PSM， the 3-year overall survival rate of the FFBMC group was higher than that of the western medicine group （

P

= 0.013）， and patients who took FFBMC for more than 12 months had higher survival rate （

P

＜0.001）. For patients in the subgroup of BCLC stage 0-A， BCLC stage B-D， Child-Pugh grade B/C， and hepatitis B-related PLC， the FFBMC group had a higher 3-year survival rate than the western medicinet group （

P

= 0.045，

P

= 0.028，

P

= 0.028 and

P

= 0.011， respectively）.

Conclusion

2

FFBMC in addition to western medicine can prolong the survival time and increase the 3-year survival rate of PLC patients with spleen deficiency and blood stasis syndrome， and those who take FFBMC for more than 1 year show more benefits.